Publications by authors named "Bas L A M Weusten"

97 Publications

Endoscopic full-thickness resection of T1 colorectal cancers: a retrospective analysis from a multicenter Dutch eFTR registry.

Endoscopy 2021 Sep 6. Epub 2021 Sep 6.

Gastroenterology & Hepatology, Amsterdam University Medical Centres, Amsterdam, Netherlands.

Background And Study Aims: Complete endoscopic resection and accurate histological evaluation for T1 colorectal cancer (CRC) is critical to determine subsequent treatment. Endoscopic Full-Thickness Resection (eFTR) is a new treatment option for T1 CRC <2cm. We aim to report clinical outcomes and short-term results.

Patients And Methods: Consecutive eFTR procedures for T1 CRC, prospectively recorded in our national registry between November 2015 and April 2020, were retrospectively analysed. Primary outcomes were technical success and R0 resection. Secondary outcomes were histological risk-assessment, curative resections, adverse events and short-term outcomes.

Results: We included 330 procedures: 132 primary resections and 198 secondary scar resections after incomplete T1 CRC resection. Overall technical success, R0 resection and curative resection rates were 87.0% (95% CI [82.7 - 90.3%]), 85.6% (95% CI [81.2 - 89.2%]) and 60.3% (95% CI [54.7 - 65.7%]). Curative resection rate for primary resected T1 CRC was 23.7% (95% CI [15.9 - 33.6%]) and 60.8% (95% CI [50.4 - 70.4%]) after excluding deep submucosal invasion as risk-factor. Risk-stratification was possible in 99.3%. Severe adverse event rates was 2.2%. Additional oncologic surgery was performed in 49/320 (15.3%), with residual cancer in 11/49 (22.4%). Endoscopic follow-up was available in 200/242 (82.6%), with a median of 4 months and residual cancer in 1 (0.5%) following an incomplete resection.

Conclusions: eFTR is a relatively safe and effective method to resect small T1 CRC, both as primary and secondary treatment. eFTR can expand endoscopic treatment options for T1 CRC and could help to reduce surgical overtreatment. Future studies should focus on long-term outcomes.
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http://dx.doi.org/10.1055/a-1637-9051DOI Listing
September 2021

Cryoballoon ablation as salvage therapy after nonradical resection of a high-risk T1b esophageal adenocarcinoma: a case report.

Eur J Gastroenterol Hepatol 2021 Jul 6. Epub 2021 Jul 6.

Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University Department of Gastroenterology and Hepatology, Elisabeth TweeSteden Hospital Department of Radiotherapy, Verbeeten Institute, Tilburg, the Netherlands.

Although esophagectomy with or without (neo)adjuvant chemoradiation therapy is the current standard of care for patients with early esophageal adenocarcinoma with high-risk features or after nonradical endoscopic resection of an early esophageal adenocarcinoma, not all patients are eligible for surgery due to varying reasons. In these patients, cryoballoon ablation may serve as an alternative treatment option considering the potential of deeper tissue ablation as compared to heat-based ablation techniques. We report the first case in which cryoballoon ablation was successfully performed as salvage therapy with a curative intent for positive deep resection margins after an incomplete endoscopic resection of a recurrent early esophageal adenocarcinoma.
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http://dx.doi.org/10.1097/MEG.0000000000002242DOI Listing
July 2021

Incidence and outcomes of poor healing and poor squamous regeneration after radiofrequency ablation therapy for early Barrett's neoplasia.

Endoscopy 2021 Jun 1. Epub 2021 Jun 1.

Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands.

Background: Endoscopic eradication therapy with radiofrequency ablation (RFA) is effective in most patients with Barrett's esophagus (BE). However, some patients experience poor healing and/or poor squamous regeneration. We evaluated incidence and treatment outcomes of poor healing and poor squamous regeneration.

Methods: We included all patients treated with RFA for early BE neoplasia from a nationwide Dutch registry based on a joint treatment protocol. Poor healing (active inflammatory changes or visible ulcerations ≥ 3 months post-RFA), poor squamous regeneration (< 50 % squamous regeneration), and treatment success (complete eradication of BE [CE-BE]) were evaluated.

Results: 1386 patients (median BE C2M5) underwent RFA with baseline low grade dysplasia (27 %), high grade dysplasia (30 %), or early cancer (43 %). In 134 patients with poor healing (10 %), additional time and acid suppression resulted in complete esophageal healing, and 67/134 (50 %) had normal squamous regeneration with 97 % CE-BE. Overall, 74 patients had poor squamous regeneration (5 %). Compared with patients with normal regeneration, patients with poor squamous regeneration had a higher risk for treatment failure (64 % vs. 2 %, relative risk [RR] 27 [95 % confidence interval [CI] 18-40]) and progression to advanced disease (15 % vs. < 1 %, RR 30 [95 %CI 12-81]). Higher body mass index, longer BE segment, reflux esophagitis, and < 50 % squamous regeneration after baseline endoscopic resection were independently associated with poor squamous regeneration in multivariable logistic regression.

Conclusions: In half of the patients with poor healing, additional time and acid suppression led to normal squamous regeneration and excellent treatment outcomes. In patients with poor squamous regeneration, however, the risk for treatment failure and progression to advanced disease was significantly increased.
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http://dx.doi.org/10.1055/a-1521-6318DOI Listing
June 2021

Feasibility of sentinel node navigated surgery in high-risk T1b esophageal adenocarcinoma patients using a hybrid tracer of technetium-99 m and indocyanine green.

Surg Endosc 2021 May 27. Epub 2021 May 27.

Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Background: Minimally invasive esophagectomy with two-field lymphadenectomy is standard of care for T1b esophageal adenocarcinoma (EAC) with a high risk of lymph node metastasis. Sentinel node navigation surgery (SNNS) is a well-known concept to tailor the extent of lymphadenectomy. The aim of this study was to evaluate the feasibility and safety of SNNS with a hybrid tracer (technetium-99 m/indocyanine green/nanocolloid) for patients with high-risk T1b EAC.

Methods: In this prospective, multicenter pilot study, 5 patients with high-risk T1b EAC were included. The tracer was injected endoscopically around the endoscopic resection scar the day before surgery, followed by preoperative imaging (lymphoscintigraphy/SPECT-CT). During surgery, first the SNs were localized and resected based on preoperative imaging and intraoperative gammaprobe- and fluorescence-based detection, followed by esophagectomy. Primary endpoints were the percentage of patients with detectable SNs, concordance between preoperative and intraoperative SN detection, and the additive value of indocyanine green.

Results: SNs could be identified and resected in all patients (median 3 SNs per patient, range 2-7). There was a high concordance between preoperative and intraoperative SN detection. In 2 patients additional peritumoral SNs were identified with fluorescence-based detection. None of the resected lymph nodes showed signs of (micro)metastases and no nodal metastases were detected in the surgical resection specimen.

Conclusions: SNNS using technetium-99 m/indocyanine green/nanocolloid seems feasible and safe in patients with high-risk T1b EAC. Indocyanine green fluorescence seems to be of additive value for detection of peritumoral SNs. Whether this approach can optimize selection for esophagectomy needs to be studied in future research.
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http://dx.doi.org/10.1007/s00464-021-08551-6DOI Listing
May 2021

Extension of early esophageal squamous cell neoplasia into ducts and submucosal glands and the role of endoscopic ablation therapy.

Gastrointest Endosc 2021 Oct 8;94(4):832-842.e2. Epub 2021 May 8.

Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, the Netherlands; Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.

Background And Aims: Early esophageal squamous cell neoplasia (ESCN) is preferably treated with en-bloc endoscopic resection. Ablation might be an alternative for flat ESCN, but ESCN extension along the epithelial lining of ducts and submucosal glands (SMGs) might jeopardize ablation efficacy. Clinical studies suggest that local recurrence might arise from such buried ESCN niches after ablation. We studied human endoscopic resection specimens of ESCN to quantify ESCN extension into ducts/SMGs and performed a prospective porcine study to evaluate the depth of radiofrequency ablation (RFA) and CryoBalloon ablation (CBA) into ducts/SMGs.

Methods: Endoscopic submucosal dissection specimens of flat-type ESCN from a Japanese (n = 65) and Dutch cohort (n = 14) were evaluated for presence and neoplastic involvement of ducts/SMGs. Twenty-seven pigs were treated with circumferential RFA (c-RFA; n = 4), focal CBA (n = 20), and focal RFA (n = 3) with 4, 60, and 9 treatment areas, respectively. After prespecified survival periods (0 hours, 8 hours, 2 days, 5 days, and 28 days), treatment areas were evaluated for uniformity and depth of ablation and affected SMGs.

Results: Neoplastic extension in ducts/SMGs was observed in most lesions: 58% (38/65) in the Japanese and 64% (9/14) in the Dutch cohort. In the animal study, 33% of SMGs (95% confidence interval, 28-50) were not affected after c-RFA, although the overlying epithelium was ablated. Focal RFA and CBA resulted in uniform ablations with effective treatment of all SMGs.

Conclusions: ESCN extends into ducts/SMGs in most patients. In an animal model, focal RFA and CBA effectively ablated SMGs, whereas c-RFA inadequately ablated SMGs. Given this potential reason for recurrence, endoscopic resection should remain the standard of care.
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http://dx.doi.org/10.1016/j.gie.2021.04.028DOI Listing
October 2021

Long-term outcomes after endoscopic treatment for Barrett's neoplasia with radiofrequency ablation ± endoscopic resection: results from the national Dutch database in a 10-year period.

Gut 2021 Mar 22. Epub 2021 Mar 22.

Gastroenterology and Hepatology, Amsterdam UMC Locatie AMC, Amsterdam, North Holland, The Netherlands.

Objective: Radiofrequency ablation (RFA)±endoscopic resection (ER) is the preferred treatment for early neoplasia in Barrett's oesophagus (BE). We aimed to report short-term and long-term outcomes for all 1384 patients treated in the Netherlands (NL) from 2008 to 2018, with uniform treatment and follow-up (FU) in a centralised setting.

Design: Endoscopic therapy for early BE neoplasia in NL is centralised in nine expert centres with specifically trained endoscopists and pathologists that adhere to a joint protocol. Prospectively collected data are registered in a uniform database. Patients with low/high-grade dysplasia or low-risk cancer, were treated by ER of visible lesions followed by trimonthly RFA sessions of any residual BE until complete eradication of BE (CE-BE). Patients with ER alone were not included.

Results: After ER (62% of cases; 43% low-risk cancers) and median 1 circumferential and 2 focal RFA (p25-p75 0-1; 1-2) per patient, CE-BE was achieved in 94% (1270/1348). Adverse events occurred in 21% (268/1386), most commonly oesophageal stenosis (15%), all were managed endoscopically. A total of 1154 patients with CE-BE were analysed for long-term outcomes. During median 43 months (22-69) and 4 endoscopies (1-5), 38 patients developed dysplastic recurrence (3%, annual recurrence risk 1%), all were detected as endoscopically visible abnormalities. Random biopsies from a normal appearing cardia showed intestinal metaplasia (IM) in 14% and neoplasia in 0%. A finding of IM in the cardia was reproduced during further FU in only 33%, none progressed to neoplasia. Frequent FU visits in the first year of FU were not associated with recurrence risk.

Conclusion: In a setting of centralised care, RFA±ER is effective for eradication of Barrett's related neoplasia and has remarkably low rates of dysplastic recurrence. Our data support more lenient FU intervals, with emphasis on careful endoscopic inspection. Random biopsies from neosquamous epithelium and cardia are of questionable value.

Netherlands Trial Register Number: NL7039.
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http://dx.doi.org/10.1136/gutjnl-2020-322615DOI Listing
March 2021

Novel cryoballoon 180° ablation system for treatment of Barrett's esophagus-related neoplasia: a first-in-human study.

Endoscopy 2021 Mar 4. Epub 2021 Mar 4.

Dept. of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands.

Background: The novel 180° cryoballoon (CbAS) enables semicircumferential treatment over a length of 3 cm per application. This first-in-human study evaluates its feasibility, efficacy, and safety for the treatment of Barrett's esophagus (BE) neoplasia.

Methods: This multicenter study consisted of dose-finding and extension phases. Dose-finding started with the lowest dose possible (1.0 mm/s). For each dose, six patients were treated circumferentially over a 3-cm length. The dose was increased until the median BE regression was ≥ 60 % without serious adverse events (SAEs). In the extension phase, the dose was confirmed in 19 new patients. The outcomes were technical success, BE regression after one treatment, and SAEs.

Results: 25 patients (median Prague C0M3) were included (6 dose-finding/19 extension). In two patients, the CbAS could not be applied because of unstable balloon positioning. The technical success rate was 96 % (22 /23). In the six dose-finding patients, the starting dose resulted in median BE regression of 94 % (95 % confidence interval [CI] 60 %-97 %) without SAEs and was thus considered effective. Overall median BE regression was 80 % (95 %CI 60 %-90 %).

Conclusion: Single-session CbAS seems feasible, safe, and effective, and is a promising technique for the treatment of patients with BE neoplasia.
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http://dx.doi.org/10.1055/a-1381-7562DOI Listing
March 2021

Individual risk calculator to predict lymph node metastases in patients with submucosal (T1b) esophageal adenocarcinoma: a multicenter cohort study.

Endoscopy 2021 Feb 24. Epub 2021 Feb 24.

Department of Pathology, Erasmus MC Cancer Institute, University Medical Center, Rotterdam, the Netherlands.

Background:  Lymph node metastasis (LNM) is possible after endoscopic resection of early esophageal adenocarcinoma (EAC). This study aimed to develop and internally validate a prediction model that estimates the individual risk of metastases in patients with pT1b EAC.

Methods:  A nationwide, retrospective, multicenter cohort study was conducted in patients with pT1b EAC treated with endoscopic resection and/or surgery between 1989 and 2016. The primary end point was presence of LNM in surgical resection specimens or detection of metastases during follow-up. All resection specimens were histologically reassessed by specialist gastrointestinal pathologists. Subdistribution hazard regression analysis was used to develop the prediction model. The discriminative ability of this model was assessed using the c-statistic.

Results:  248 patients with pT1b EAC were included. Metastases were seen in 78 patients, and the 5-year cumulative incidence was 30.9 % (95 % confidence interval [CI] 25.1 %-36.8 %). The risk of metastases increased with submucosal invasion depth (subdistribution hazard ratio [SHR] 1.08, 95 %CI 1.02-1.14, for every increase of 500 μm), lymphovascular invasion (SHR 2.95, 95 %CI 1.95-4.45), and for larger tumors (SHR 1.23, 95 %CI 1.10-1.37, for every increase of 10 mm). The model demonstrated good discriminative ability (c-statistic 0.81, 95 %CI 0.75-0.86).

Conclusions:  A third of patients with pT1b EAC experienced metastases within 5 years. The probability of developing post-resection metastases was estimated with a personalized predicted risk score incorporating tumor invasion depth, tumor size, and lymphovascular invasion. This model requires external validation before implementation into clinical practice.
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http://dx.doi.org/10.1055/a-1399-4989DOI Listing
February 2021

Toward improved endoscopic surveillance with multidiameter single fiber reflectance spectroscopy in patients with Barrett's esophagus.

J Biophotonics 2021 04 31;14(4):e202000351. Epub 2021 Jan 31.

Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands.

Patients with Barrett's esophagus are at an increased risk to develop esophageal cancer and, therefore, undergo regular endoscopic surveillance. Early detection of neoplasia enables endoscopic treatment, which improves outcomes. However, early Barrett's neoplasia is easily missed during endoscopic surveillance. This study investigates multidiameter single fiber reflectance spectroscopy (MDSFR) to improve Barrett's surveillance. Based on the concept of field cancerization, it may be possible to identify the presence of a neoplastic lesion from measurements elsewhere in the esophagus or even the oral cavity. In this study, MDSFR measurements are performed on non-dysplastic Barrett's mucosa, squamous mucosa, oral mucosa, and the neoplastic lesion (if present). Based on logistic regression analysis on the scattering parameters measured by MDSFR, a classifier is developed that can predict the presence of neoplasia elsewhere in the Barrett's segment from measurements on the non-dysplastic Barrett's mucosa (sensitivity 91%, specificity 71%, AUC = 0.77). Classifiers obtained from logistic regression analysis for the squamous and oral mucosa do not result in an AUC significantly different from 0.5.
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http://dx.doi.org/10.1002/jbio.202000351DOI Listing
April 2021

Radiofrequency vapor ablation for Barrett's esophagus: feasibility, safety and proof of concept in a stepwise study with in vitro, animal, and the first in-human application.

Endoscopy 2020 Nov 20. Epub 2020 Nov 20.

Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands.

Introduction:  The Radiofrequency Vapor Ablation (RFVA) System (AquaMedical, Inc., Santa Ana, CA) is a novel ablation system for eradication of Barrett's esophagus, that generates vapor at 100 °C using an RF electrode located in the catheter tip. We performed in-vitro dosimetry studies and the first in-human feasibility study.

Methods:  The system includes an RFVA generator with syringe pump and a through-the-scope-catheter. The RFVA system was tested in-vitro (lean-beef and porcine study) and ablation depth was compared to focal RFA. Two doses were selected for further in-vivo testing in dysplatic BE patients. Repeat endoscopy with histology was performed after 8 weeks to assess squamous conversion.

Results:  In porcine, RFVA 3-seconds was comparable to RFA, whereas RFVA 5-seconds produced slightly deeper ablation. We selected a conservative 1-second and 3-seconds for human study. Fifty-three ablations were successfully applied in 15 patients with no adverse events. Follow-up endoscopy showed a median squamous conversion of 55 % (IQR 33 - 74) and 98 % (56 - 99) for 1 and 3-seconds, respectively.

Conclusions:  In this 3-phase study with lean-beef, porcine and the first in-human application, the RFVA system was feasible for esophageal ablation and successfully and safely converted targeted BE areas into squamous epithelium.
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http://dx.doi.org/10.1055/a-1319-5550DOI Listing
November 2020

Updates in Cryotherapy for Barrett's Esophagus.

Gastrointest Endosc Clin N Am 2021 Jan;31(1):155-170

Department of Gastroenterology and Hepatology, University Medical Center Utrecht, PO Box 85500, 3508 GA Utrecht, the Netherlands; Department of Gastroenterology and Hepatology, St. Antonius Hospital, Koekoekslaan 1, PO Box 2500, 3430 EM Nieuwegein, the Netherlands. Electronic address:

Cryotherapy is an ablation modality relying on freeze-thaw cycles to promote cell death through intracellular ice crystal formation, ischemia, and apoptosis. Currently, 2 different cryotherapy systems are available for esophageal use. The first is cryospray ablation, which involves repetitive applications of liquid nitrogen. The second system, cryoballoon ablation, freezes the esophageal mucosa with liquid nitrous oxide using a compliant balloon. To date, studies have shown that cryotherapy is an effective and safe method for eradicating Barrett's esophagus; however, larger prospective series with longer follow-up are warranted to determine the clinical utility of cryotherapy in the treatment of Barrett's esophagus.
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http://dx.doi.org/10.1016/j.giec.2020.09.005DOI Listing
January 2021

Prospective development and validation of a volumetric laser endomicroscopy computer algorithm for detection of Barrett's neoplasia.

Gastrointest Endosc 2021 04 29;93(4):871-879. Epub 2020 Jul 29.

Department of Gastroenterology and Hepatology, Amsterdam UMC, location AMC, Amsterdam, the Netherlands.

Background And Aims: Volumetric laser endomicroscopy (VLE) is an advanced imaging modality used to detect Barrett's esophagus (BE) dysplasia. However, real-time interpretation of VLE scans is complex and time-consuming. Computer-aided detection (CAD) may help in the process of VLE image interpretation. Our aim was to train and validate a CAD algorithm for VLE-based detection of BE neoplasia.

Methods: The multicenter, VLE PREDICT study, prospectively enrolled 47 patients with BE. In total, 229 nondysplastic BE and 89 neoplastic (high-grade dysplasia/esophageal adenocarcinoma) targets were laser marked under VLE guidance and subsequently underwent a biopsy for histologic diagnosis. Deep convolutional neural networks were used to construct a CAD algorithm for differentiation between nondysplastic and neoplastic BE tissue. The CAD algorithm was trained on a set consisting of the first 22 patients (134 nondysplastic BE and 38 neoplastic targets) and validated on a separate test set from patients 23 to 47 (95 nondysplastic BE and 51 neoplastic targets). The performance of the algorithm was benchmarked against the performance of 10 VLE experts.

Results: Using the training set to construct the algorithm resulted in an accuracy of 92%, sensitivity of 95%, and specificity of 92%. When performance was assessed on the test set, accuracy, sensitivity, and specificity were 85%, 91%, and 82%, respectively. The algorithm outperformed all 10 VLE experts, who demonstrated an overall accuracy of 77%, sensitivity of 70%, and specificity of 81%.

Conclusions: We developed, validated, and benchmarked a VLE CAD algorithm for detection of BE neoplasia using prospectively collected and biopsy-correlated VLE targets. The algorithm detected neoplasia with high accuracy and outperformed 10 VLE experts. (The Netherlands National Trials Registry (NTR) number: NTR 6728.).
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http://dx.doi.org/10.1016/j.gie.2020.07.052DOI Listing
April 2021

Transanal minimally invasive surgery (TAMIS) versus endoscopic submucosal dissection (ESD) for resection of non-pedunculated rectal lesions (TRIASSIC study): study protocol of a European multicenter randomised controlled trial.

BMC Gastroenterol 2020 Jul 13;20(1):225. Epub 2020 Jul 13.

Pathan B.V. - Pathology Laboratorium, Rotterdam, The Netherlands.

Background: In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden.

Methods: Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior.

Discussion: This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future.

Trial Registration: Netherlands Trial Register, NL7083 , 06 July 2018.
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http://dx.doi.org/10.1186/s12876-020-01367-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7359465PMC
July 2020

Endoscopic full-thickness resection (eFTR) of colorectal lesions: results from the Dutch colorectal eFTR registry.

Endoscopy 2020 11 4;52(11):1014-1023. Epub 2020 Jun 4.

Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, location AMC, Amsterdam Gastroenterology & Metabolism, University of Amsterdam, Amsterdam, The Netherlands.

Background: Endoscopic full-thickness resection (eFTR) is a minimally invasive resection technique that allows definite diagnosis and treatment for complex colorectal lesions ≤ 30 mm unsuitable for conventional endoscopic resection. This study reports clinical outcomes from the Dutch colorectal eFTR registry.

Methods: Consecutive patients undergoing eFTR in 20 hospitals were prospectively included. The primary outcome was technical success, defined as macroscopic complete en bloc resection. Secondary outcomes were: clinical success, defined as tumor-free resection margins (R0 resection); full-thickness resection rate; and adverse events. RESULTS : Between July 2015 and October 2018, 367 procedures were included. Indications were difficult polyps (non-lifting sign and/or difficult location; n = 133), primary resection of suspected T1 colorectal cancer (CRC; n = 71), re-resection after incomplete resection of T1 CRC (n = 150), and subepithelial tumors (n = 13). Technical success was achieved in 308 procedures (83.9 %). In 21 procedures (5.7 %), eFTR was not performed because the lesion could not be reached or retracted into the cap. In the remaining 346 procedures, R0 resection was achieved in 285 (82.4 %) and full-thickness resection in 288 (83.2 %). The median diameter of resected specimens was 23 mm. Overall adverse event rate was 9.3 % (n = 34/367): 10 patients (2.7 %) required emergency surgery for five delayed and two immediate perforations and three cases of appendicitis. CONCLUSION : eFTR is an effective and relatively safe en bloc resection technique for complex colorectal lesions with the potential to avoid surgery. Further studies assessing the role of eFTR in early CRC treatment with long-term outcomes are needed.
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http://dx.doi.org/10.1055/a-1176-1107DOI Listing
November 2020

Endoscopic management of gastrointestinal motility disorders - part 2: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

Endoscopy 2020 07 27;52(7):600-614. Epub 2020 May 27.

Department of Gastroenterology, Dudley Group NHS Foundation Trust and Birmingham City University, Birmingham, UK.

ESGE suggests flexible endoscopic treatment over open surgical treatment as first-line therapy for patients with a symptomatic Zenker's diverticulum of any size.Weak recommendation, low quality of evidence, level of agreement 100 %.ESGE recommends that emerging treatments for Zenker's diverticulum, such as Zenker's peroral endoscopic myotomy (Z-POEM) and tunneling, be considered as experimental; these treatments should be offered in a research setting only.Strong recommendation, low quality of evidence, level of agreement 100 %.ESGE recommends against the widespread clinical use of transoral incisionless fundoplication (TIF) as an alternative to proton pump inhibitor (PPI) therapy or antireflux surgery in the treatment of gastroesophageal reflux disease (GERD), because of the lack of data on the long-term outcomes, the inferiority of TIF to fundoplication, and its modest efficacy in only highly selected patients. TIF may have a role for patients with mild GERD who are not willing to take PPIs or undergo antireflux surgery.Strong recommendation, moderate quality of evidence, level of agreement 92.8 %.ESGE recommends against the use of the Medigus ultrasonic surgical endostapler (MUSE) in clinical practice because of insufficient data showing its effectiveness and safety in patients with GERD. MUSE should be used in clinical trials only.Strong recommendation, low quality evidence, level of agreement 100 %.ESGE recommends against the use of antireflux mucosectomy (ARMS) in routine clinical practice in the treatment of GERD because of the lack of data and its potential complications.Strong recommendation, low quality evidence, level of agreement 100 %.ESGE recommends endoscopic cecostomy only after conservative management with medical therapies or retrograde lavage has failed.Strong recommendation, low quality evidence, level of agreement 93.3 %.ESGE recommends fixing the cecum to the abdominal wall at three points (using T-anchors, a double-needle suturing device, or laparoscopic fixation) to prevent leaks and infectious adverse events, whatever percutaneous endoscopic cecostomy method is used.Strong recommendation, very low quality evidence, level of agreement 86.7 %.ESGE recommends considering endoscopic decompression of the colon in patients with Ogilvie's syndrome that is not improving with conservative treatment.Strong recommendation, low quality evidence, level of agreement 93.8 %.ESGE recommends prompt endoscopic decompression if the cecal diameter is > 12 cm and if the Ogilvie's syndrome exists for a duration of longer than 4 - 6 days.Strong recommendation, low quality evidence, level of agreement 87.5 %.
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http://dx.doi.org/10.1055/a-1171-3174DOI Listing
July 2020

Endoscopic management of gastrointestinal motility disorders - part 1: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

Endoscopy 2020 06 6;52(6):498-515. Epub 2020 May 6.

Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.

ESGE recommends the use of a graded pneumatic dilation protocol in achalasia, starting with a 30-mm dilation and followed by a 35-mm dilation at a planned interval of 2 - 4 weeks, with a subsequent 40-mm dilation when there is insufficient relief, over both a single balloon dilation procedure or the use of a larger balloon from the outset.Strong recommendation, high quality of evidence, level of agreement 100 %.ESGE recommends being cautious in treating spastic motility disorders other than achalasia with peroral endoscopic myotomy (POEM).Strong recommendation, very low quality of evidence, level of agreement 87.5 %.ESGE recommends against the routine use of botulinum toxin injections to treat patients with non-achalasia hypercontractile esophageal motility disorders (Jackhammer esophagus, distal esophageal spasm). However, if, in individual patients, endoscopic injection of botulinum toxin is chosen, ESGE recommends performing injections into four quadrants of the lower esophageal sphincter and in the lower third of the esophagus.Strong recommendation, low quality of evidence, level of agreement 78.6 %.ESGE recommends that endoscopic pylorus-directed therapy should be considered only in patients with symptoms suggestive of gastroparesis in combination with objective proof of delayed gastric emptying using a validated test, and only when medical therapy has failed.Strong recommendation, very low quality of evidence, level of agreement 100 %.ESGE recommends against the use of botulinum toxin injection in the treatment of unselected patients with gastroparesis. Strong recommendation, high quality of evidence, level of agreement 92.9 %.ESGE recommends consideration of gastric peroral endoscopic myotomy (G-POEM) in carefully selected patients only, because it is an emerging procedure with limited data on effectiveness, safety, and durability. G-POEM should be performed in expert centers only, preferably in the context of a clinical trial.Strong recommendation, low quality of evidence, level of agreement 100 %.
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http://dx.doi.org/10.1055/a-1160-5549DOI Listing
June 2020

Blue-light imaging and linked-color imaging improve visualization of Barrett's neoplasia by nonexpert endoscopists.

Gastrointest Endosc 2020 05 3;91(5):1050-1057. Epub 2020 Jan 3.

Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Background And Aims: Endoscopic recognition of early Barrett's neoplasia is challenging. Blue-light imaging (BLI) and linked-color imaging (LCI) may assist endoscopists in appreciation of neoplasia. Our aim was to evaluate BLI and LCI for visualization of Barrett's neoplasia in comparison with white-light endoscopy (WLE) alone, when assessed by nonexpert endoscopists.

Methods: In this web-based assessment, corresponding WLE, BLI, and LCI images of 30 neoplastic Barrett's lesions were delineated by 3 expert endoscopists to establish ground truth. These images were then scored and delineated by 76 nonexpert endoscopists from 3 countries and with different levels of expertise, in 4 separate assessment phases with a washout period of 2 weeks. Assessments were as follows: assessment 1, WLE only; assessment 2, WLE + BLI; assessment 3, WLE + LCI; assessment 4, WLE + BLI + LCI. The outcomes were (1) appreciation of macroscopic appearance and ability to delineate lesions (visual analog scale [VAS] scores); (2) preferred technique (ordinal scores); and (3) assessors' delineation performance in terms of overlap with expert ground truth.

Results: Median VAS scores for phases 2 to 4 were significantly higher than in phase 1 (P < .001). Assessors preferred BLI and LCI over WLE for appreciation of macroscopic appearance (P < .001) and delineation (P < .001). Linear mixed-effect models showed that delineation performance increased significantly in phase 4.

Conclusions: The use of BLI and LCI has significant additional value for the visualization of Barrett's neoplasia when used by nonexpert endoscopists. Assessors appreciated the addition of BLI and LCI better than the use of WLE alone. Furthermore, this addition led to improved delineation performance, thereby allowing for better acquisition of targeted biopsy samples. (The Netherlands Trial Registry number: NL7541.).
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http://dx.doi.org/10.1016/j.gie.2019.12.037DOI Listing
May 2020

A novel cryoballoon ablation system for eradication of dysplastic Barrett's esophagus: a first-in-human feasibility study.

Endoscopy 2020 03 11;52(3):193-201. Epub 2019 Nov 11.

Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands.

Background: Endoscopic cryoablation for Barrett's esophagus (BE) might offer advantages over heat-based ablation. Focal cryoballoon ablation has been promising for short-segment BE, whereas the novel 90°-swipe cryoballoon ablation system (CbSAS) ablates larger areas in a single step (90° over 3 cm). The system allows for dose adjustment. CbSAS has been feasible and safe in animal and pre-esophagectomy studies. This is the first clinical study to assess feasibility, safety, and efficacy of CbSAS for eradication of dysplastic BE.

Methods: In this prospective study in dysplastic BE patients, dose finding started with semi-circumferential treatment at 0.8 mm/s (dose 1). The dose was escalated by reducing speed by 0.1 mm/s in six patients until BE surface regression was ≥ 80 % without complications ("effective dose"). The effective dose was subsequently confirmed with circumferential treatment in 12 new patients. Post-procedural pain (0 - 10) and dysphagia (0 - 4) were evaluated. Outcomes were feasibility, safety, and BE surface regression.

Results: 25 patients were included, with technically successful treatment in 92 % (95 %CI 73 % - 99 %). Median (95 %CI) BE surface regression was 78 % (50 % - 85 %) for dose 1 and 85 % (55 % - 95 %) for dose 2 (0.7 mm/s), which was defined as the effective dose. Circumferential treatment resulted in 93 % (88 % - 96 %) regression. Two of 12 patients with circumferential treatment developed strictures that required dilation. Median pain and dysphagia scores were low (0 - 3 and 0, respectively).

Conclusions: CbSAS was feasible and effective for ablating larger BE areas. The optimal dose for circumferential treatment that balances safety and efficacy requires further evaluation.
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http://dx.doi.org/10.1055/a-1024-3967DOI Listing
March 2020

Distribution of lymph node metastases in esophageal adenocarcinoma after neoadjuvant chemoradiation therapy: a prospective study.

Surg Endosc 2020 10 17;34(10):4347-4357. Epub 2019 Oct 17.

Department of Surgery, Amsterdam UMC (Location AMC), University of Amsterdam, Cancer Center Amsterdam, 1105 AZ, Amsterdam, The Netherlands.

Background: The distribution of lymph node metastases in esophageal adenocarcinoma following neoadjuvant chemoradiation (nCRTx) is unclear, but may have consequences for radiotherapy and surgery. The aim of this study was to define the distribution of lymph node metastases and relation to the radiation field in patients following nCRTx and esophagectomy.

Methods: Between April 2014 and August 2015 esophageal adenocarcinoma patients undergoing transthoracic esophagectomy with 2-field lymphadenectomy following nCRTx were included in this prospective observational study. Lymph node stations according to AJCC 7 were separately investigated. The location of lymph node metastases in relation to the radiation field was determined. The primary endpoint was the distribution of lymph node metastases and relation to the radiation field, the secondary endpoints were high-risk stations and risk factors for lymph node metastases and relation to survival.

Results: Fifty consecutive patients were included. Lymph node metastases were found in 60% of patients and most frequently observed in paraesophageal (28%), left gastric artery (24%), and celiac trunk (18%) stations. Fifty-two percent had lymph node metastases within the radiation field. The incidence of lymph node metastases correlated significantly with ypT-stage (p = 0.002), cT-stage (p = 0.005), lymph angioinvasion (p = 0.004), and Mandard (p = 0.002). The number of lymph node metastases was associated with survival in univariable analysis (HR 1.12, 95% CI 1.068-1.173, p < 0.001).

Conclusions: Esophageal adenocarcinoma frequently metastasizes to both the mediastinal and abdominal lymph node stations. In this study, more than half of the patients had lymph node metastases within the radiation field. nCRTx is therefore not a reason to minimize lymphadenectomy in patients with esophageal adenocarcinoma.
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http://dx.doi.org/10.1007/s00464-019-07205-yDOI Listing
October 2020

Curriculum for endoscopic submucosal dissection training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

Endoscopy 2019 10 30;51(10):980-992. Epub 2019 Aug 30.

Department of Gastroenterology and Hepatology, University Hospitals Leuven, and TARGID, KU Leuven, Belgium.

There is a need for well-organized comprehensive strategies to achieve good training in ESD. In this context, the European Society of Gastrointestinal Endoscopy (ESGE) have developed a European core curriculum for ESD practice across Europe with the aim of high quality ESD training.Advanced endoscopy diagnostic practice is advised before initiating ESD training. Proficiency in endoscopic mucosal resection (EMR) and adverse event management is recommended before starting ESD trainingESGE discourages the starting of initial ESD training in humans. Practice on animal and/or ex vivo models is useful to gain the basic ESD skills. ESGE recommends performing at least 20 ESD procedures in these models before human practice, with the goal of at least eight en bloc complete resections in the last 10 training cases, with no perforation. ESGE recommends observation of experts performing ESD in tertiary referral centers. Performance of ESD in humans should start on carefully selected lesions, ideally small ( < 30 mm), located in the antrum or in the rectum for the first 20 procedures. Beginning human practice in the colon is not recommended. ESGE recommends that at least the first 10 human ESD procedures should be done under the supervision of an ESD-proficient endoscopist.Endoscopists performing ESD should be able to correctly estimate the probability of performing a curative resection based on the characteristics of the lesion and should know the benefit/risk relationship of ESD when compared with other therapeutic alternatives. Endoscopists performing ESD should know how to interpret the histopathology findings of the ESD specimen, namely the criteria for low risk resection ("curative"), local risk resection, and high risk resection ("non-curative"), as well as their implications. ESD should be performed only in a setting where early and delayed complications can be managed adequately, namely with the possibility of admitting patients to a ward, and access to appropriate emergency surgical teams for the organ being treated with ESD.
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http://dx.doi.org/10.1055/a-0996-0912DOI Listing
October 2019

Self-sizing radiofrequency ablation balloon for eradication of Barrett's esophagus: results of an international multicenter randomized trial comparing 3 different treatment regimens.

Gastrointest Endosc 2019 09 17;90(3):415-423. Epub 2019 May 17.

Department of Gastroenterology and Hepatology, UZ Gasthuisberg, Leuven, Belgium.

Background And Aims: Recently, the 360 Express radiofrequency ablation balloon catheter (360 Express, Medtronic, Minneapolis, Minn, USA) has replaced the traditional system for circumferential radiofrequency ablation (RFA) of Barrett's esophagus (BE). The aim was to compare 3 different ablation regimens for the 360 Express.

Methods: An international multicenter noninferiority randomized controlled trial was conducted in which patients with a BE (2-15 cm) with dysplasia or early cancer were randomly assigned to the standard (1 × 10 J/cm-clean-1 × 10 J/cm), simple-double (2 × 10 J/cm-no clean), or simple-single ablation regimen (1 × 10 J/cm-no clean). The primary outcome was the percentage endoscopically visual BE regression at 3 months. Secondary outcomes were procedure time, adverse events, and patient discomfort.

Results: Between September 2015 and October 2017, 104 patients were enrolled. The simple-double ablation arm was closed prematurely because of a 21% stenosis rate. The trial continued with the standard (n = 37) and simple-single arm (n = 38). Both arms were comparable at baseline. Noninferiority of the simple-single arm could not be demonstrated: BE regression was 73% in the simple-single arm versus 85% in the standard arm; the median difference was 13% (95% confidence interval, 5%-23%). The procedure time was significantly longer in the standard arm (31 vs 17 minutes, P < .001). Both groups were comparable with regard to adverse events and patient discomfort.

Conclusions: This randomized trial shows that circumferential RFA with the 360 Express using the simple-double ablation regimen results in an unacceptable high risk of stenosis. Furthermore, the results suggest that a single ablation at 10 J/cm results in inferior BE regression at 3 months. We therefore advise using the standard ablation regimen (1 × 10 J/cm-clean-1 × 10 J/cm) for treatment of BE using the 360 Express. (Clinical trial registration number: NTR5191.).
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http://dx.doi.org/10.1016/j.gie.2019.05.023DOI Listing
September 2019

Impact of ablation of Barrett's esophagus with low-grade dysplasia on patients' illness perception and quality of life: a multicenter randomized trial.

Gastrointest Endosc 2019 08 23;90(2):215-221. Epub 2019 Apr 23.

Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Background And Aims: A previous multicenter randomized trial demonstrated that radiofrequency ablation (RFA) significantly reduced the risk of neoplastic progression compared with surveillance (1.5% vs 26.5%) in patients with Barrett's esophagus (BE) and low-grade dysplasia (LGD). In the same population, this study aimed to compare the quality of life (QOL) and illness perception (IP) among patients treated with RFA and patients kept under surveillance.

Methods: From June 2007 to June 2011, patients with BE and LGD were randomly assigned to RFA or surveillance. QOL and IP were assessed at baseline, 2, 9, 14, 26, and 38 months. Standardized questionnaires were used (SF-36, EORTC QLQ-C30, EORTC QLQ-OES18, and the brief Illness Perception Questionnaire [IPQ]).

Results: Forty-seven patients in the ablation group and 49 patients in the surveillance group completed the questionnaires (median follow-up, 36 months). Marginal differences were observed in the SF-36 and the EORTC-QLQ-C30. Based on the EORTC-QLQ-OES18, the ablation group reported more diarrhea (7.8 vs 4.0; P = .018), whereas the surveillance group reported more reflux (15.1 vs 9.0; P < .001) and more problems with speaking (4.3 vs 2.2; P = .019). The IPQ showed that patients in the ablation group perceived their disease lasted for a shorter period of time (P < .001), experienced fewer symptoms (P < .001), had fewer concerns about their condition (P < .001), and tended to be less emotionally affected by their condition (P = .012) than patients in the surveillance group. As a result, patients who underwent ablation experienced their condition as less threatening compared with patients in the surveillance group (P < .001).

Conclusion: Patients treated with ablation for BE with LGD reported a QOL comparable with that of patients undergoing endoscopic surveillance; however, the patients in the ablation group had fewer concerns and a less-threatening view of their condition. (Clinical trial registration number [www.trialregister.nl]: NTR1198; 25-1-2008.).
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http://dx.doi.org/10.1016/j.gie.2019.04.226DOI Listing
August 2019

Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China.

Gastrointest Endosc 2019 08 25;90(2):204-212. Epub 2019 Mar 25.

Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Background And Aims: Esophageal squamous cell neoplasia (ESCN) has a significant risk for progression to cancer. Current treatment options, endoscopic mucosal resection (EMR) or submucosal dissection (ESD), have their limitations. The cryoballoon focal ablation system (CbFAS) is a novel endoscopic ablation therapy device. We aimed to assess the safety, tolerability, and efficacy of CbFAS for eradication of ESCN.

Methods: In this single-center prospective trial in China, patients with 1 flat unstained lesion (USL) on Lugol chromoendoscopy that contained moderate- or high-grade intraepithelial neoplasia (MGIN or HGIN, respectively) were enrolled. CbFAS was performed using side-by-side applications of 10 seconds, treatment was repeated at 3-month intervals until a complete response (CR) was established. The response at 12 months was the primary trial endpoint. Safety phone calls were performed at 2, 7, and 30 days after the initial CbFAS.

Results: We enrolled 80 patients (59 MGIN, 21 HGIN) with a median USL length of 3 cm (interquartile range [IQR], 3-4). Seventy-nine received treatment, with a median of 5 side-by-side applications (IQR, 4-7) per patient over a median of 8 minutes (IQR, 5-10). After a single treatment, 70 of 78 patients (90%) exhibited CR, and 1 was lost to follow-up. The other 8 with persisting USLs were retreated, and all achieved CR after this second treatment. At 12 months after the initial CbFAS, 76 of 78 patients (97%) exhibited CR and 2 (3%) had recurrent MGIN. No strictures or serious adverse events occurred. Four patients developed self-limiting mucosal lacerations on balloon inflation. The postprocedure median pain score was 1 of 10 (IQR, 0-2) at day 2 and 0 (0-0) at days 7 and 30.

Conclusions: The results suggest that the CbFAS is safe, well tolerated, and effective in inducing endoscopic and histologic remission in patients with ESCN of limited size. (Clinical trial registration number: NCT02605759.).
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http://dx.doi.org/10.1016/j.gie.2019.03.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7545726PMC
August 2019

Optimizing histopathologic evaluation of EMR specimens of Barrett's esophagus-related neoplasia: a randomized study of 3 specimen handling methods.

Gastrointest Endosc 2019 09 22;90(3):384-392.e5. Epub 2019 Mar 22.

Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, the Netherlands; Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.

Background And Aims: Endoscopic resection is the cornerstone of treatment of Barrett's esophagus (BE)-related neoplasia. However, accurate histopathologic evaluation of endoscopic resection specimens can be challenging, and the preferred specimen handling method remains unknown. Therefore, the aim of our study was to compare 3 different specimen handling methods for assessment of all clinically relevant histopathologic parameters and time required for specimen handling.

Methods: In this multicenter, randomized study EMR specimens of BE-related neoplasia with no suspicion of submucosal invasion during endoscopy were randomized to 3 specimen handling methods: pinning on paraffin using needles, direct fixation in formalin without prior tissue handling, and the cassette technique (small box for enclosing specimens). The histopathologic evaluation scores were assessed by 2 dedicated GI pathologists blinded to the handling method.

Results: Of the 126 randomized EMR specimens, 45 were assigned to pinning on paraffin, 41 to direct fixation in formalin, and 40 to the cassette technique. The percentages of specimens with overall optimal histopathologic evaluation scores were similar for the pinning method (98%; 95% confidence interval [CI], 88.0-99.9) and for no handling (90%; 95% CI, 76.9-97.3) but were significantly lower (64%; 95% CI, 47.2-78.8) for the cassette technique (P < .001). Time required for specimen handling was shortest when no handling method was used (P < .001 vs pinning and cassette).

Conclusions: Both pinning on paraffin and direct fixation in formalin resulted in optimal histopathologic evaluation scores in a high proportion of specimens, whereas the cassette technique performs significantly worse, and its use in clinical daily practice should be discouraged. Given the significantly shorter handling time, direct fixation in formalin appears to be the preferred method over pinning on paraffin. However, the latter needs to be confirmed in larger studies with inclusion of all EMR specimens. (Clinical trial registration number: ISRCTN50525266.).
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http://dx.doi.org/10.1016/j.gie.2019.03.014DOI Listing
September 2019

Durability of radiofrequency ablation for treatment of esophageal squamous cell neoplasia: 5-year follow-up of a treated cohort in China.

Gastrointest Endosc 2019 04 26;89(4):736-748.e2. Epub 2018 Oct 26.

Department of Endoscopy, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China.

Background And Aims: Radiofrequency ablation (RFA) is an accepted treatment for flat Barrett's neoplasia. Less is known about RFA for esophageal squamous cell neoplasia (ESCN). Our group has reported several prospective studies of RFA for ESCN in China with promising results through 12 months of follow-up. In this cohort study we aimed to evaluate longer term outcomes after RFA for ESCN.

Methods: Patients with flat unstained lesions (USLs) on Lugol's endoscopy containing moderate-/high-grade intraepithelial neoplasia (MGIN/HGIN) or mucosal cancer were treated with RFA every 3 months until complete remission (CR; no MGIN or a worse histologic grade). Patients with CR at 12 months (CR12) were included for follow-up and underwent annual Lugol's endoscopy with biopsy sampling and re-RFA for flat USLs. The clinical course of patients with persistent ESCN at 12 months (treatment failures) is also reported.

Results: Among the 78 patients in CR12, 67 (86%) had sustained CR during a median of 48 months (interquartile range, 48-48) of follow-up and 5 endoscopies (interquartile range, 4-6). Recurrence occurred in 7 of 78 patients (9%; MGIN, n = 6; HGIN, n = 1); all lesions were managed with RFA. Four other patients (5%) had progression (to HGIN, n = 1; submucosal esophageal squamous cell carcinoma, n = 3). During follow-up protocol violations occurred in 46 of 78 patients (59%). Of the 12 treatment failures, progression occurred in 6. Overall, 2 patients developed subepithelial disease that was not visible after Lugol's endoscopy. Based on post-hoc analysis, the pink-color sign at baseline (a pink color change after Lugol's endoscopy) significantly predicted failure after RFA.

Conclusions: RFA is relatively easy to apply and can efficiently treat large areas with ESCN. Despite protocol violations that may have interfered with the efficacy of RFA in 59% of patients, most patients with CR12 had sustained CR during follow-up. However, some patients progressed to advanced disease and 2 developed subepithelial disease, not visible after Lugol's endoscopy. Based on currently available data, we advise the restriction of the use of RFA for flat MGIN and HGIN without the pink-color sign on Lugol's chromoendoscopy. (Clinical trial registration number: NCT02047305.).
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http://dx.doi.org/10.1016/j.gie.2018.10.030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7517876PMC
April 2019

Efficacy of individual and group hypnotherapy in irritable bowel syndrome (IMAGINE): a multicentre randomised controlled trial.

Lancet Gastroenterol Hepatol 2019 Jan 23;4(1):20-31. Epub 2018 Nov 23.

Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, Netherlands.

Background: Hypnotherapy for irritable bowel syndrome (IBS) has been used primarily in patients with refractory symptoms in specialised departments and delivered on an individual basis. We aimed to test the hypothesis that hypnotherapy would be more effective than educational supportive therapy, and that group hypnotherapy would be non-inferior to individual hypnotherapy for patients with IBS referred from primary and secondary care.

Methods: We did a multicentre randomised controlled trial (IMAGINE) in 11 hospitals in the Netherlands. Patients with IBS, aged 18-65 years, who were referred from primary or secondary care were randomly allocated (3:3:1) in blocks of six using a computer-based random number table procedure by staff not involved in the treatment to receive six sessions of individual or group hypnotherapy or group educational supportive therapy (control group). The primary outcome was adequate relief of IBS symptoms, with responders defined as patients who reported adequate relief when asked once weekly on three or four occasions in 4 consecutive weeks. We compared hypnotherapy (both groups) with control in the intention-to-treat population (excluding individuals subsequently found to be ineligible for enrolment), and assessed non-inferiority of group hypnotherapy versus individual hypnotherapy in the per-protocol population (with a non-inferiority margin of 15%) at 3 months and 12 months. This trial is registered with ISRCTN, number ISRCTN22888906, and is completed.

Findings: Between May 31, 2011, and April 6, 2016, 494 patients referred for psychological treatment for IBS were assessed for eligibility, of whom 354 were randomly allocated to the three groups: 150 to individual hypnotherapy, 150 to group hypnotherapy, and 54 to educational supportive therapy. After exclusion of individuals subsequently found to be ineligible for enrolment, 142 patients in the individual hypnotherapy group, 146 in the group hypnotherapy group, and 54 in the control group were included in the intention-to-treat population. Of these, 22 (15%) patients in the individual hypnotherapy group, 22 (15%) in the group hypnotherapy group, and 11 (20%) in the control group dropped out before or during therapy. In the intention-to-treat analysis, the adequate response rate was 40·8% (95% CI 31·7-50·5) in the individual hypnotherapy group, 33·2% (24·3-43·5) in the group hypnotherapy group, and 16·7% (7·6-32·6) in the control group at 3 months. At 12 months, 40·8% (31·3-51·1) of patients in the individual hypnotherapy group, 49·5% (38·8-60·0) of patients in the group hypnotherapy group, and 22.6% (11·5-39·5) of patients in the control group reported adequate relief. Hypnotherapy was more effective than control at 3 months (odds ratio 2·9, 95% CI 1·2-7·4, p=0·0240) and 12 months (2·8, 1·2-6·7, p=0·0185). In the per-protocol analysis, 49·9% (39·2-60·6) in the individual hypnotherapy group and 42·7% (32·3-53·8) in the group hypnotherapy group had adequate relief at 3 months, and 55·5% (43·4-67·1) of individual and 51·7% (40·2-63·0) of group hypnotherapy patients reported adequate relief at 12 months. Group hypnotherapy was therefore non-inferior to individual hypnotherapy. Eight unexpected serious adverse reactions (six in the individual hypnotherapy group and two in the group hypnotherapy group) were reported, most of which were cancer or inflammatory bowel disease, and were judged by the medical ethics committee as not being related to the therapy.

Interpretation: Hypnotherapy should be considered as a possible treatment for patients with IBS in primary and secondary care. Furthermore, group therapy could allow many more patients to be treated for the same cost.

Funding: None.
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http://dx.doi.org/10.1016/S2468-1253(18)30310-8DOI Listing
January 2019

Blue-light imaging has an additional value to white-light endoscopy in visualization of early Barrett's neoplasia: an international multicenter cohort study.

Gastrointest Endosc 2019 04 9;89(4):749-758. Epub 2018 Nov 9.

Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Background And Aims: Endoscopic features of early neoplasia in Barrett's esophagus (BE) are subtle. Blue-light imaging (BLI) may improve visualization of neoplastic lesions. The aim of this study was to evaluate BLI in visualization of Barrett's neoplasia.

Methods: Corresponding white-light endoscopy (WLE) and BLI images of 40 BE lesions were obtained prospectively and assessed by 6 international experts in 3 assessments. Each assessment consisted of overview and magnification images. Assessments were as follows: assessment 1, WLE only; assessment 2, BLI only; and assessment 3, corresponding WLE and BLI images. Outcome parameters were as follows: (1) appreciation of macroscopic appearance and surface relief (visual analog scale scores); (2) ability to delineate lesions (visual analog scale scores); (3) preferred technique for delineation (ordinal scores); and (4) quantitative agreement on delineations (AND/OR scores).

Results: Experts appreciated BLI significantly better than WLE for visualization of macroscopic appearance (median 8.0 vs 7.0, P < .001) and surface relief (8.0 vs 6.0, P < .001). For both overview and magnification images, experts appreciated BLI significantly better than WLE for ability to delineate lesions (8.0 vs 6.0, P < .001 and 8.0 vs 5.0, P < .001). There was no overall significant difference in AND/OR scores of WLE + BLI when compared with WLE, yet agreement increased significantly with WLE + BLI for cases with a low baseline AND/OR score on WLE, both in overview (mean difference, 0.15; P = .015) and magnification (mean difference, 0.10; P = .01).

Conclusions: BLI has additional value for visualization of BE neoplasia. Experts appreciated BLI better than WLE for visualization and delineation of BE neoplasia. Quantitative agreement increased significantly when BLI was offered next to WLE for lesions that were hard to delineate with WLE alone. (ISRCTN registry study ID: ISRCTN15916689.).
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http://dx.doi.org/10.1016/j.gie.2018.10.046DOI Listing
April 2019

Simplified versus standard regimen for focal radiofrequency ablation of dysplastic Barrett's oesophagus: a multicentre randomised controlled trial.

Lancet Gastroenterol Hepatol 2018 08 20;3(8):566-574. Epub 2018 Jun 20.

Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, Netherlands; Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, Netherlands. Electronic address:

Background: For focal radiofrequency ablation of Barrett's oesophagus, a simplified regimen (3 × 15 J/cm, without cleaning) has proven to be as effective as the standard regimen (2 × 15 J/cm, followed by cleaning, followed by 2 × 15 J/cm). However, this simplified regimen seemed to be associated with a higher stenosis rate. Therefore, we lowered the radiofrequency energy and hypothesised that this new simplified regimen would be as effective and safe as the standard regimen.

Methods: This randomised non-inferiority trial included patients with dysplastic Barrett's oesophagus or residual Barrett's oesophagus after endoscopic resection or circumferential radiofrequency ablation, in five European tertiary referral centres. Patients were randomly assigned (1:1) to the new simplified regimen (3 × 12 J/cm, without cleaning) or the standard regimen, with variable block sizes of four, six, and eight patients, stratified by participating hospital. Focal radiofrequency ablation was done every 3 months, up to a maximum of three treatments, until all Barrett's oesophagus was eradicated. The primary outcome was complete endoscopic and histological regression of dysplasia and intestinal metaplasia after two focal radiofrequency ablation treatments, assessed in the intention-to-treat population. Non-inferiority was assessed on the basis of the difference between groups in the median percentage of Barrett's oesophagus surface regression, with a non-inferiority margin of -15%. This study is registered with www.trialregister.nl, number NTR4994, and is completed.

Findings: Between March 25, 2015, and July 25, 2016, 84 patients were randomly assigned to treatment: 44 to receive the simplified regimen and 40 to receive the standard regimen. One patient assigned to the simplified regimen and four assigned to the standard regimen were excluded because they weree found not to be eligible; therefore the final intention-to-treat population consisted of 43 patients in the simplified ablation group and 36 in the standard ablation group. Complete endoscopic and histological regression of dysplasia and intestinal metaplasia after two focal radiofrequency ablation treatments was achieved in 32 (74%, 95% CI 59-87) patients treated with the simplified protocol, versus 30 (83%, 95% CI 67-94) patients treated with the standard protocol (p=0·34). Median Barrett's oesophagus surface regression after two focal radiofrequency ablation sessions was 98% (IQR 95-100) in the simplified regimen group and 100% (97-100) in the standard regimen group. The difference between medians was 2% (95% CI -0·562 to 3·162); thus the simplified regimen was deemed non-inferior to the standard regimen. Stenoses requiring dilatation were observed in four (9%) of 43 patients in the simplified regimen group and four (11%) of 36 in the standard regimen group. Post-procedural bleeding requiring repeat endoscopy occurred in one (2%) patient in the simplified ablation group and three (8%) patients in the standard ablation group. One patient (2%) in the simplified treatment group died 36 days after the second radiofrequency ablation procedure, due to an unknown cause.

Interpretation: Based on the results of this study, we conclude that the simplified regimen is the preferred regimen for focal radiofrequency ablation of Barrett's oesophagus.

Funding: None.
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http://dx.doi.org/10.1016/S2468-1253(18)30157-2DOI Listing
August 2018
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