Publications by authors named "Sanne N van Munster"

11 Publications

  • Page 1 of 1

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

Gastrointest Endosc 2021 May 8. Epub 2021 May 8.

Dept. of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands;; Dept. of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands;. Electronic address:

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 depth of radiofrequency ablation (RFA) and CryoBalloon ablation (CBA) into ducts/SMGs.

Methods: ESD 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 (n=4), focal CBA (n=20), and focal RFA (n=3) with 4/60/9 treatment areas, respectively. After prespecified survival periods (0h/8h/2d/5d/28d), treatment areas were evaluated for uniformity and depth of ablation and affected SMGs.

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

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

Recurrent intestinal metaplasia in the gastroesophageal junction after endoscopic eradication of Barrett's: Is ignorance bliss?

Gastrointest Endosc 2021 Mar 7. Epub 2021 Mar 7.

Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam Gastroenterology Endocrinology and Metabolism, Cancer Center, Amsterdam, The Netherlands.

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http://dx.doi.org/10.1016/j.gie.2020.12.025DOI 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

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

Successful endoscopic treatment of Barrett's dysplasia is not just about the destination; it is about the journey.

Gastrointest Endosc 2020 09;92(3):551-553

Department of Gastroenterology and Hepatology, Amsterdam Universitair Medische Centra, Vrije Universiteit Amsterdam, Amsterdam, Netherlands; Amsterdam Gastroenterology Endocrinology Metabolism, Cancer Center Amsterdam, Amsterdam, Netherlands.

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http://dx.doi.org/10.1016/j.gie.2020.04.057DOI Listing
September 2020

Aneuploidy in targeted endoscopic biopsies outperforms other tissue biomarkers in the prediction of histologic progression of Barrett's oesophagus: A multi-centre prospective cohort study.

EBioMedicine 2020 Jun 24;56:102765. Epub 2020 May 24.

MRC Cancer Unit, University of Cambridge, Hutchison/MRC Research Centre, Box 197, Cambridge Biomedical Campus, Cambridge CB2 0XZ, United Kingdom. Electronic address:

Background: The cancer risk in Barrett's oesophagus (BO) is difficult to estimate. Histologic dysplasia has strong predictive power, but can be missed by random biopsies. Other clinical parameters have limited utility for risk stratification. We aimed to assess whether a molecular biomarker panel on targeted biopsies can predict neoplastic progression of BO.

Methods: 203 patients with BO were tested at index endoscopy for 9 biomarkers (p53 and cyclin A expression; aneuploidy and tetraploidy; CDKN2A (p16), RUNX3 and HPP1 hypermethylation; 9p and 17p loss of heterozygosity) on autofluorescence-targeted biopsies and followed-up prospectively. Data comparing progressors to non-progressors were evaluated by univariate and multivariate analyses using survival curves, Cox-proportional hazards and logistic regression models.

Findings: 127 patients without high-grade dysplasia (HGD) or oesophageal adenocarcinoma (OAC) at index endoscopy were included, of which 42 had evidence of any histologic progression over time. Aneuploidy was the only predictor of progression from non-dysplastic BO (NDBO) to any grade of neoplasia (p = 0.013) and HGD/OAC (p = 0.002). Aberrant p53 expression correlated with risk of short-term progression within 12 months, with an odds ratio of 6.0 (95% CI: 3.1-11.2). A panel comprising aneuploidy and p53 had an area under the receiving operator characteristics curve of 0.68 (95% CI: 0.59-0.77) for prediction of any progression.

Interpretation: Aneuploidy is the only biomarker that predicts neoplastic progression of NDBO. Aberrant p53 expression suggests prevalent dysplasia, which might have been missed by random biopsies, and warrants early follow up.
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http://dx.doi.org/10.1016/j.ebiom.2020.102765DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7251385PMC
June 2020

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

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

Focal cryoballoon versus radiofrequency ablation of dysplastic Barrett's esophagus: impact on treatment response and postprocedural pain.

Gastrointest Endosc 2018 11 19;88(5):795-803.e2. Epub 2018 Jun 19.

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: Radiofrequency ablation (RFA) is safe and effective for eradicating Barrett's esophagus (BE) but is associated with significant postprocedural pain. Alternatively, balloon-based focal cryoablation (CRYO) has recently been developed, which preserves the extracellular matrix and might therefore be less painful. Although data for CRYO are still limited, uncontrolled studies suggest comparable safety and efficacy to RFA in eradicating limited BE areas. Therefore, secondary endpoints such as pain might become decisive for treatment selection. We aimed to compare efficacy and tolerability between focal CRYO and RFA.

Methods: We identified BE patients undergoing focal ablation (either RFA or CRYO) of all visible BE from our prospective cohort in 2 Dutch referral centers. After ablation, patients completed a 14-day digital diary to assess chest pain (0-10), dysphagia (0-4), and analgesics use. A follow-up endoscopy was scheduled after 3 months to assess the BE surface regression (blindly scored by 2 independent BE expert endoscopists). Outcomes were BE surface regression; 14-day cumulative scores (area under the curves [AUCs]) for pain, dysphagia, analgesics, and peak pain.

Results: We identified 46 patients (20 CRYO, 26 RFA) with similar baseline characteristics. The BE regression was comparable (88% vs 90%, P = .62). AUCs for pain, dysphagia, and analgesics were significantly smaller after CRYO versus RFA (all P < .01). Peak pain was lower after CRYO (visual analog scale 2 vs 4, P < .01), and the duration of pain was also shorter after CRYO (2 vs 4 days, P < .01). CRYO patients used analgesics for 2 days versus 4 days for RFA (P < .01).

Conclusions: In this multicenter, nonrandomized cohort study, we found no differences in efficacy after a single treatment with CRYO and RFA for short-segment BE. Patients reported less pain after CRYO as compared with RFA. Moreover, CRYO patients used fewer analgesics. Our results suggest a different pain course favoring CRYO over RFA, but a randomized trial is needed for definitive conclusions. (Clinical trial registration number: NCT02249975.).
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http://dx.doi.org/10.1016/j.gie.2018.06.015DOI Listing
November 2018

Effect modification in the association between glycated haemoglobin and cardiovascular disease and mortality in patients with type 2 diabetes.

Diabetes Obes Metab 2017 03 28;19(3):320-328. Epub 2016 Dec 28.

Department of Vascular Medicine, University Medical Centre Utrecht, Utrecht, The Netherlands.

Aim: To identify patients with type 2 diabetes (T2D) who may benefit from lower or higher glycated haemoglobin (HbA1c) targets, based on readily available patient characteristics.

Materials And Methods: Patients with T2D were included in the present study from the Second Manifestations of ARTerial disease (SMART) cohort. Several patient characteristics were evaluated for effect modification in the relationship between HbA1c and cardiovascular disease and all-cause mortality, using multiplicative interaction analyses and stratified Cox proportional hazard analyses. Combinations of patient characteristics, as used in existing treatment algorithms, were similarly evaluated.

Results: Of 1753 patients, 323 experienced a vascular event during a median of 6.6 years of follow-up and 375 patients died. For the association between HbA1c and cardiovascular events, no effect modifiers were found. Body mass index (BMI) and weight showed significant interaction for the association between HbA1c and mortality ( P = .04). Analyses, stratified for 25 kg/m or 30 or 35 kg/m , showed quite dissimilar hazard ratios without reaching statistical significance. Combinations of patient characteristics used in existing treatment algorithms, did not influence the relationship between HbA1c and cardiovascular disease or mortality ( P = .46 to P = .92).

Conclusions: Using easily obtainable patient characteristics, whether alone or in combinations used in existing treatment algorithms, it was not possible, except for BMI or weight, considered continuously, to identify patients with T2D who had a differential association between HbA1c and cardiovascular events or all-cause mortality in our cohort.
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http://dx.doi.org/10.1111/dom.12820DOI Listing
March 2017

Magnetic resonance enterography findings of a gastrocolic fistula in Crohn's disease.

Quant Imaging Med Surg 2016 Aug;6(4):482-485

Department of Radiology, Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands.

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http://dx.doi.org/10.21037/qims.2016.08.06DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5009107PMC
August 2016