Publications by authors named "Jan-Werner Poley"

86 Publications

Long-term yield of pancreatic cancer surveillance in high-risk individuals.

Gut 2021 Apr 5. Epub 2021 Apr 5.

Department of Gastroenterology & Hepatology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.

Objective: We aimed to determine the long-term yield of pancreatic cancer surveillance in hereditary predisposed high-risk individuals.

Design: From 2006 to 2019, we prospectively enrolled asymptomatic individuals with an estimated 10% or greater lifetime risk of pancreatic ductal adenocarcinoma (PDAC) after obligatory evaluation by a clinical geneticist and genetic testing, and subjected them to annual surveillance with both endoscopic ultrasonography (EUS) and MRI/cholangiopancreatography (MRI/MRCP) at each visit.

Results: 366 individuals (201 mutation-negative familial pancreatic cancer (FPC) kindreds and 165 PDAC susceptibility gene mutation carriers; mean age 54 years, SD 9.9) were followed for 63 months on average (SD 43.2). Ten individuals developed PDAC, of which four presented with a symptomatic interval carcinoma and six underwent resection. The cumulative PDAC incidence was 9.3% in the mutation carriers and 0% in the FPC kindreds (p<0.001). Median PDAC survival was 18 months (range 1-32). Surgery was performed in 17 individuals (4.6%), whose pathology revealed 6 PDACs (3 T1N0M0), 7 low-grade precursor lesions, 2 neuroendocrine tumours <2 cm, 1 autoimmune pancreatitis and in 1 individual no abnormality. There was no surgery-related mortality. EUS detected more solid lesions than MRI/MRCP (100% vs 22%, p<0.001), but less cystic lesions (42% vs 83%, p<0.001).

Conclusion: The diagnostic yield of PDAC was substantial in established high-risk mutation carriers, but non-existent in the mutation-negative proven FPC kindreds. Nevertheless, timely identification of resectable lesions proved challenging despite the concurrent use of two imaging modalities, with EUS outperforming MRI/MRCP. Overall, surveillance by imaging yields suboptimal results with a clear need for more sensitive diagnostic markers, including biomarkers.
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http://dx.doi.org/10.1136/gutjnl-2020-323611DOI Listing
April 2021

Influence of a novel classification of the papilla of Vater on the outcome of needle-knife fistulotomy for biliary cannulation.

BMC Gastroenterol 2021 Apr 1;21(1):147. Epub 2021 Apr 1.

Cintesis - Center for Health Technology and Services Research, Porto, Portugal.

Background: Existing proposed classification systems for the Papilla of Vater (PV) suboptimally account for all relevant, encountered PV appearances, are too complex or have not been assessed for intra- or interobserver variability. We proposed a novel endoscopic classification system for PV, determined its inter- and intraobserver rates and used the classification system to assess whether the success and complications of needle-knife fistulotomy (NKF) are influenced by the morphology of the PV.

Methods: The classification system was developed by expert endoscopists. To evaluate the inter- and intraobserver agreement, an online questionnaire was sent to 20 endoscopists from several countries (10 experts and 10 nonexperts) that included 50 images of papillae of Vater divided among various categories. Four weeks later, a second survey, with the images from the first questionnaire randomly reordered, was sent to the same endoscopists. The inter- and intraobserver agreements among the experts and nonexperts was calculated. Using the proposed classification system, all 361 consecutive patients who underwent NKF for biliary access to a naïve papilla were prospectively enrolled in the study.

Results: The novel classification system comprises 7 categories: type I, flat type, lacking an oral protrusion; type IIA, prominent tubular nonpleated type, with an oral protrusion and < 1 transverse fold over the oral protrusion; type IIB, prominent tubular pleated type, with an oral protrusion and > 2 transverse folds over the oral protrusion; type IIC: prominent bulging type, with an enlarged and bulging oral protrusion; type IIIA, diverticular-intradiverticular type, with a papillary orifice inside the diverticulum; type IIIB: diverticular-diverticular border type, with a papillary orifice less than 2 cm from the diverticular border; type IV: unclassified papilla, with no morphology classified in the other categories. The interobserver agreement between experts was substantial (K = 0.611, 95% CI 0.498-0.709) and was higher than that between nonexperts (K = 0.516; 95% CI 0.410-0.636). The intraobserver agreement was substantial among both experts (K = 0,651; 95% CI 0.586-0.715) and nonexperts (K = 0.646, 95% CI 0.615-0.677). In a multivariate model, type IIIA and IIIB were the only independent risk factors for difficult rescue NKF biliary cannulation (P = 0.003 and P = 0.019, respectively), and type I and type IIB were the only independent risk factors for a prolonged cannulation time using NKF (P < 0.001 and P = 0.005, respectively).

Conclusions: The novel endoscopic classification system for PV is highly reproducible among experienced ERCPists according to the substantial level of agreement between experts. However, nonexperts require further training in its use. Using the novel classification system, we identified different types of papillae significantly associated with a lower efficacy of NKF and a prolonged time to obtain successful biliary cannulation using NKF.
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http://dx.doi.org/10.1186/s12876-021-01735-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8017832PMC
April 2021

Fully Covered Self-Expanding Metal Stent versus Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial.

Gastroenterology 2021 Mar 16. Epub 2021 Mar 16.

Asian Institute of Gastroenterology, Hyderabad, India. Electronic address:

Background & Aims: Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients.

Methods: Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS versus FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of ERCPs and stents, and stent- or procedure-related serious adverse events (SAEs).

Results: Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs. FCSEMS respectively, stricture resolution status at 24 months was 77.1% (54/70) vs. 75.8% (47/62) (P=0.008 for noninferiority ITT analysis), mean number of ERCPs was 3.9±1.3 vs. 2.6±1.3 (P<0.001, ITT), and mean number of stents placed was 7.0±4.4 vs. 1.3±0.6 (P<0.001, as-treated). SAEs occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P=0.568), including cholangitis/fever/jaundice (9 vs. 7 patients respectively), abdominal pain (5 vs. 5), cholecystitis (1 vs. 3) and post-ERCP pancreatitis (0 vs. 2). No stent- or procedure-related deaths occurred.

Conclusions: Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared to a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256).
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http://dx.doi.org/10.1053/j.gastro.2021.03.015DOI Listing
March 2021

Prevalence of and risk factors for stent migration-induced duodenal perforation.

Endosc Int Open 2021 Mar 19;9(3):E461-E469. Epub 2021 Feb 19.

Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.

The safety of transpapillary biliary drainage by stent placement through endoscopic retrograde cholangiography (ERC) may be compromised by the occurrence of stent migration-induced perforation of the duodenal wall (SMDP). We aimed to assess the prevalence rate, risk factors and clinical course of SMDP. This retrospective cohort study included all patients who underwent an ERC with biliary plastic stent placement, between January 2014 and December 2018. Patients with an SMDP were identified from our endoscopy complication registry.  1227 patients underwent an ERC, of whom 629 patients (51 %) with biliary plastic stent placement; in 304 patients (25 %) stents were placed for perihilar strictures. Thirteen patients with SMDP were identified. The prevalence was 2.1 % for patients with biliary plastic stent placement and 4.3 % for patients stented for a perihilar stricture. All SMDPs occurred in patients with a perihilar stricture and with stents ≥ 12 cm (range 12-20 cm). Another potential risk factor was stent insertion into the left liver lobe, which was present in 10 of 13 patients. In 10 of 13 patients, SMDP was clinically suspected. Three of 13 patients were asymptomatic and diagnosed at elective stent retrieval. Eight patients could be endoscopically treated with an over-the-scope clip. Four patients died due to abdominal sepsis despite repeated interventions.  SMDP is a rare but potentially life-threatening complication of ERC after transpapillary drainage for perihilar biliary strictures. Stents ≥ 12 cm and stent insertion into the left liver lobe may be associated risk factors.
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http://dx.doi.org/10.1055/a-1337-2321DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7895667PMC
March 2021

Human Bile Contains Cholangiocyte Organoid-Initiating Cells Which Expand as Functional Cholangiocytes in Non-canonical Wnt Stimulating Conditions.

Front Cell Dev Biol 2020 9;8:630492. Epub 2021 Feb 9.

Department of Surgery, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.

Diseases of the bile duct (cholangiopathies) remain a common indication for liver transplantation, while little progress has been made over the last decade in understanding the underlying pathophysiology. This is largely due to lack of proper model systems to study cholangiopathies. Recently, a culture method has been developed that allows for expansion of human bile duct epithelial cells grown as extrahepatic cholangiocyte organoids (ncECOs) in non-canonical Wnt-stimulating conditions. These ncECOs closely resemble cholangiocytes in culture and have shown to efficiently repopulate collagen scaffolds that could act as functional biliary tissue in mice. Thus far, initiation of ncECOs required tissue samples, thereby limiting broad patient-specific applications. Here, we report that bile fluid, which can be less invasively obtained and with low risk for the patients, is an alternative source for culturing ncECOs. Further characterization showed that bile-derived cholangiocyte organoids (ncBCOs) are highly similar to ncECOs obtained from bile duct tissue biopsies. Compared to the previously reported bile-cholangiocyte organoids cultured in canonical Wnt-stimulation conditions, ncBCOs have superior function of cholangiocyte ion channels and are able to respond to secretin and somatostatin. In conclusion, bile is a new, less invasive, source for patient-derived cholangiocyte organoids and makes their regenerative medicine applications more safe and feasible.
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http://dx.doi.org/10.3389/fcell.2020.630492DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900156PMC
February 2021

Pain patterns in chronic pancreatitis: a nationwide longitudinal cohort study.

Gut 2020 Nov 6. Epub 2020 Nov 6.

Department of Surgery, University Medical Centre, Utrecht, The Netherlands

Objective: Pain in chronic pancreatitis is subdivided in a continuous or intermittent pattern, each thought to represent a different entity, requiring specific treatment. Because evidence is missing, we studied pain patterns in a prospective longitudinal nationwide study.

Design: 1131 patients with chronic pancreatitis (fulfilling M-ANNHEIM criteria) were included between 2011 and 2018 in 30 Dutch hospitals. Patients with continuous or intermittent pain were compared for demographics, pain characteristics, quality of life (Short-Form 36), imaging findings, disease duration and treatment. Alternation of pain pattern and associated variables were longitudinally assessed using a multivariable multinomial logistic regression model.

Results: At inclusion, 589 patients (52%) had continuous pain, 231 patients (20%) had intermittent pain and 311 patients (28%) had no pain. Patients with continuous pain had more severe pain, used more opioids and neuropathic pain medication, and had a lower quality of life. There were no differences between pain patterns for morphological findings on imaging, disease duration and treatment. During a median follow-up of 47 months, 552 of 905 patients (61%) alternated at least once between pain patterns. All alternations were associated with the Visual Analogue Scale pain intensity score and surgery was only associated with the change from pain to no pain.

Conclusion: Continuous and intermittent pain patterns in chronic pancreatitis do not seem to be the result of distinctly different pathophysiological entities. The subjectively reported character of pain is not related to imaging findings or disease duration. Pain patterns often change over time and are merely a feature of how severity of pain is experienced.
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http://dx.doi.org/10.1136/gutjnl-2020-322117DOI Listing
November 2020

Optimization of Pancreatic Juice Collection: A First Step Toward Biomarker Discovery and Early Detection of Pancreatic Cancer.

Am J Gastroenterol 2020 12;115(12):2103-2108

Department of Gastroenterology & Hepatology, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.

Introduction: Imaging-based surveillance programs fail to detect pancreatic ductal adenocarcinoma at a curable stage, creating an urgent need for diagnostic biomarkers.

Methods: Secretin-stimulated pancreatic juice (PJ) was collected from the duodenal lumen during endoscopic ultrasound. The yield of biomarkers and organoids was compared for 2 collection techniques (endoscope suction channel vs catheter-based) and 3 periods (0-4 vs 4-8 vs 8-15 minutes).

Results: Collection through the endoscope suction channel was superior to collection with a catheter. Collection beyond 8 minutes reduced biomarker yield. PJ-derived organoid culture was feasible.

Discussion: The optimal protocol for secretin-stimulated PJ collection is through the endoscope suction channel for 8 minutes allowing biomarker detection and organoid culture.
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http://dx.doi.org/10.14309/ajg.0000000000000939DOI Listing
December 2020

Optimizing cytological specimens of EUS-FNA of solid pancreatic lesions: A pilot study to the effect of a smear preparation training for endoscopy personnel on sample quality and accuracy.

Diagn Cytopathol 2021 Feb 24;49(2):295-302. Epub 2020 Oct 24.

Department of Pathology, Erasmus MC University Medical Center Rotterdam, the Netherlands and Institute for Pathology, Dueren, Germany.

Background: In the absence of rapid on-side pathological evaluation, endoscopy staff generally "smears" endoscopic ultrasound guided fine needle aspiration (EUS-FNA) specimens on a glass slide. As this technique is vulnerable to preparation artifacts, we assessed if its quality could be improved through a smear-preparation-training for endoscopy staff.

Methods: In this prospective pilot study, 10 endosonographers and 12 endoscopy nurses from seven regional EUS-centers in the Netherlands were invited to participate in a EUS-FNA smear-preparation-training. Subsequently, post training slides derived from solid pancreatic lesions were compared to pre-training "control" slides. Primary outcome was to assess if the training positively affects smear quality and, consequently, diagnostic accuracy of EUS-FNA of solid pancreatic lesions.

Results: Participants collected and prepared 71 cases, mostly pancreatic head lesions (48%). Sixty-eight controls were selected from the pretraining period. The presence of artifacts was comparable for smears performed before and after training (76% vs 82%, P = .36). Likewise, smear cellularity (≥50% target cells) before and after training did not differ (44% (30/68) vs 49% (35/71), P = .48). Similar, no difference in diagnostic accuracy for malignancy was detected (P = .10).

Conclusion: In this pilot EUS-FNA smear-preparation-training for endoscopy personnel, smear quality and diagnostic accuracy were not improved after the training. Based on these results, we plan to further study other training programs and possibilities.
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http://dx.doi.org/10.1002/dc.24645DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820998PMC
February 2021

Patency of endoscopic ultrasound-guided gastroenterostomy in the treatment of malignant gastric outlet obstruction.

Endosc Int Open 2020 Sep 31;8(9):E1194-E1201. Epub 2020 Aug 31.

Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.

Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) with a lumen-apposing metal stent (LAMS) is a novel, minimally invasive technique in the palliative treatment of malignant gastric outlet obstruction (GOO). Several studies have demonstrated feasibility and safety of EUS-GE, but evidence on long-term durability is limited. The aim of this study was to evaluate patency of EUS-GE in treatment of malignant GOO. An international multicenter study was performed in seven centers in four European countries. Patients who underwent EUS-GE with a LAMS between March 2015 and March 2019 for palliative treatment of symptomatic malignant GOO were included retrospectively. Our main outcome was recurrent obstruction due to LAMS dysfunction; other outcomes of interest were technical success, clinical success, adverse events (AEs), and survival. A total of 45 patients (mean age 69.9 ± 12.3 years and 48.9 % male) were included. Median duration of follow-up was 59 days (interquartile range [IQR] 41-128). Recurrent obstruction occurred in two patients (6.1 %), after 33 and 283 days of follow-up. Technical success was achieved in 39 patients (86.7 %). Clinical success was achieved in 33 patients (73.3 %). AEs occurred in 12 patients (26.7 %), of which five were fatal. Median overall survival was 57 days (IQR 32-114). EUS-GE showed a low rate of recurrent obstruction. The relatively high number of fatal AEs underscores the importance of careful implementation of EUS-GE in clinical practice.
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http://dx.doi.org/10.1055/a-1214-5659DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458745PMC
September 2020

An international, multi-institution survey on performing EUS-FNA and fine needle biopsy.

Endosc Ultrasound 2020 Sep-Oct;9(5):319-328

Department of Gastroenterology, Sheng Jing Hospital of China Medical University, Shenyang, Liaoning Province, China.

Background And Objectives: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) and fine needle biopsy (FNB) are effective techniques that are widely used for tissue acquisition. However, it remains unclear how to obtain high-quality specimens. Therefore, we conducted a survey of EUS-FNA and FNB techniques to determine practice patterns worldwide and to develop strong recommendations based on the experience of experts in the field.

Methods: This was a worldwide multi-institutional survey among members of the International Society of EUS Task Force (ISEUS-TF). The survey was administered by E-mail through the SurveyMonkey website. In some cases, percentage agreement with some statements was calculated; in others, the options with the greatest numbers of responses were summarized. Another questionnaire about the level of recommendation was designed to assess the respondents' answers.

Results: ISEUS-TF members developed a questionnaire containing 17 questions that was sent to 53 experts. Thirty-five experts completed the survey within the specified period. Among them, 40% and 54.3% performed 50-200 and more than 200 EUS sampling procedures annually, respectively. Some practice patterns regarding FNA/FNB were recommended.

Conclusion: This is the first worldwide survey of EUS-FNA and FNB practice patterns. The results showed wide variations in practice patterns. Randomized studies are urgently needed to establish the best approach for optimizing the FNA/FNB procedures.
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http://dx.doi.org/10.4103/eus.eus_56_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811723PMC
September 2020

Role of endoscopic ultrasonography in the diagnostic work-up of idiopathic acute pancreatitis (PICUS): study protocol for a nationwide prospective cohort study.

BMJ Open 2020 08 20;10(8):e035504. Epub 2020 Aug 20.

AMC, Amsterdam, North Holland, The Netherlands.

Introduction: Idiopathic acute pancreatitis (IAP) remains a dilemma for physicians as it is uncertain whether patients with IAP may actually have an occult aetiology. It is unclear to what extent additional diagnostic modalities such as endoscopic ultrasonography (EUS) are warranted after a first episode of IAP in order to uncover this aetiology. Failure to timely determine treatable aetiologies delays appropriate treatment and might subsequently cause recurrence of acute pancreatitis. Therefore, the aim of the Pancreatitis of Idiopathic origin: Clinical added value of endoscopic UltraSonography (PICUS) Study is to determine the value of routine EUS in determining the aetiology of pancreatitis in patients with a first episode of IAP.

Methods And Analysis: PICUS is designed as a multicentre prospective cohort study of 106 patients with a first episode of IAP after complete standard diagnostic work-up, in whom a diagnostic EUS will be performed. Standard diagnostic work-up will include a complete personal and family history, laboratory tests including serum alanine aminotransferase, calcium and triglyceride levels and imaging by transabdominal ultrasound, magnetic resonance imaging or magnetic resonance cholangiopancreaticography after clinical recovery from the acute pancreatitis episode. The primary outcome measure is detection of aetiology by EUS. Secondary outcome measures include pancreatitis recurrence rate, severity of recurrent pancreatitis, readmission, additional interventions, complications, length of hospital stay, quality of life, mortality and costs, during a follow-up period of 12 months.

Ethics And Dissemination: PICUS is conducted according to the Declaration of Helsinki and Guideline for Good Clinical Practice. Five medical ethics review committees assessed PICUS (Medical Ethics Review Committee of Academic Medical Center, University Medical Center Utrecht, Radboud University Medical Center, Erasmus Medical Center and Maastricht University Medical Center). The results will be submitted for publication in an international peer-reviewed journal.

Trial Registration Number: Netherlands Trial Registry (NL7066). Prospectively registered.
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http://dx.doi.org/10.1136/bmjopen-2019-035504DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7440829PMC
August 2020

Outcomes of biliopancreatic EUS in patients with surgically altered upper gastrointestinal anatomy: a multicenter study.

Endosc Int Open 2020 Jul 16;8(7):E869-E876. Epub 2020 Jun 16.

Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, G.B. Rossi University Hospital, Verona, Italy.

Little is known about outcomes of biliopancreatic endosonography (EUS) in patients with surgically altered upper gastrointestinal (gastrointestinal) anatomy. We aimed to assess the rate of procedural success and EUS-related adverse events (AEs), according to post-surgical anatomies. Retrospective study including patients with post-surgical altered upper gastrointestinal anatomy who underwent EUS for evaluation of the biliopancreatic region between January 2008 and June 2018 at eight European centers. Of 242 patients (162 males, mean age 66.4 ± 12.5), 86 had (35.5 %) Billroth II, 77 (31.8 %) pancreaticoduodenectomy, 23 (9.5 %) Billroth I, 19 (7.9 %) distal esophagectomy, 15 (6.2 %) total gastrectomy, 14 (5.8 %) sleeve gastrectomy, and eight (3.3 %) Roux-en-Y. Sleeve gastrectomy, Billroth I, and pancreaticoduodenectomy were associated with high rates of success (100 %, 95.7 %, and 92.2 %, respectively). Visualization of the head of the pancreas was significantly impacted by total gastrectomy, Billroth II, and Roux-en-Y (success rates 6.7 %, 53.7 %, and 57.1 %, respectively). Examination of the pancreatic body and tail was impaired in esophagectomy and total gastrectomy (82.4 % and 71.4 %, respectively). Technical success and diagnostic accuracy of EUS-guided tissue acquisition (EUS-TA) was 78.2 % and 71.3 % (95 % CI, 60.6-80.5), respectively. Four (1.6 %) AEs were observed: one mucosal tearing in a Billroth II patient, one cardiac arrest in a distal esophagectomy patient, one bleed after EUS-TA in a Billroth I patient, and one acute pancreatitis after EUS-TA in a sleeve gastrectomy patient. The yield of bilio-pancreatic EUS is dependent on lesion location and surgery type. Before considering EUS in these patients, one must carefully consider whether the lesion may be approachable by EUS.
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http://dx.doi.org/10.1055/a-1161-8713DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7297615PMC
July 2020

Clinical outcome of endoscopic treatment for symptomatic sterile walled-off necrosis.

Endoscopy 2021 Feb 12;53(2):136-144. Epub 2020 Jun 12.

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

Background:  The majority of patients with symptomatic sterile walled-off necrosis (WON) can be treated conservatively. Although endoscopic transluminal drainage (ETD) is often performed in cases of persistent symptoms, post-procedural iatrogenic infection may occur. This study aimed to evaluate clinical outcomes after ETD of symptomatic sterile WON.

Methods:  This was a retrospective, multicenter, open-label case series of 56 patients with necrotizing pancreatitis who underwent ETD for symptomatic sterile WON between July 2001 and August 2018 at two tertiary referral hospitals. Primary end point was clinically relevant post-procedural iatrogenic infection, defined as need for endoscopic transluminal necrosectomy. Secondary end points included mortality, total number of interventions, hospital stay, and resolution of symptoms at 1-year follow-up.  RESULTS : ETD of sterile WON was performed in 56 patients (median age 55 years, 57 % male), who presented with abdominal pain (71 %), gastric outlet obstruction (45 %), jaundice (20 %), and failure to thrive (27 %). A total of 41 patients (73 %) developed clinically relevant post-procedural iatrogenic infection, resulting in a median of 3 (interquartile range [IQR] 2 - 4) endoscopic, radiological, and/or surgical interventions. Mortality rate was 2 %. Median total hospital stay was 12 days (IQR 6 - 17). Resolution of symptoms was reported in 40 of 46 patients (87 %) for whom long-term follow-up data were available (median follow-up 13 months, IQR 6 - 29).

Conclusions: ETD of symptomatic sterile WON resulted in high clinical success. Nonetheless, the majority of patients required additional reinterventions for clinically relevant post-procedural iatrogenic infection.
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http://dx.doi.org/10.1055/a-1198-7501DOI Listing
February 2021

Fully covered self-expanding metal stents for benign biliary stricture after orthotopic liver transplant: 5-year outcomes.

Gastrointest Endosc 2020 12 15;92(6):1216-1224. Epub 2020 May 15.

Department of Gastroenterology and Hepato-pancreatology, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.

Background And Aims: Minimally invasive treatments of anastomotic benign biliary stricture (BBS) after orthotopic liver transplantation (OLT) include endoscopic placement of multiple plastic stents or fully covered self-expandable metal stents (FCSEMSs). No multiyear efficacy data are available on FCSEMS treatment after OLT.

Methods: We prospectively studied long-term efficacy and safety of FCSEMS treatment in adults aged ≥18 years with past OLT, cholangiographically confirmed BBS, and an indication for ERCP with stent placement. Stent removal was planned after 4 to 6 months, with subsequent follow-up until 5 years or stricture recurrence. Long-term outcomes were freedom from stricture recurrence, freedom from recurrent stent placement, and stent-related serious adverse events (SAEs).

Results: In 41 patients, long-term follow-up began after FCSEMS removal (n = 33) or observation of complete distal migration (CDM) (n = 8). On an intention-to-treat basis, the 5-year probability of remaining stent-free after FCSEMS removal or observation of CDM was 48.9% (95% confidence interval [CI], 33.2%-64.7%) among all patients and 60.9% (95% CI, 43.6%-78.2%) among 31 patients with over 4 months of FCSEMS indwell time. In 28 patients with stricture resolution at FCSEMS removal or observed CDM (median, 5.0 months indwell time), the 5-year probability of no stricture recurrence was 72.6% (95% CI, 55.3%-90%). Sixteen patients (39%) had at least 1 related SAE, most commonly cholangitis (n = 10).

Conclusions: By 5 years after temporary FCSEMS treatment of post-OLT BBS, approximately half of all patients remained stent-free on an intention-to-treat basis. Stent-related SAEs (especially cholangitis) were common. FCSEMS placement is a viable long-term treatment option for patients with post-OLT BBS. (Clinical trial registration number: NCT01014390.).
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http://dx.doi.org/10.1016/j.gie.2020.04.078DOI Listing
December 2020

Patient-reported burden of intensified surveillance and surgery in high-risk individuals under pancreatic cancer surveillance.

Fam Cancer 2020 07;19(3):247-258

Department of Gastroenterology & Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.

In high-risk individuals participating in a pancreatic cancer surveillance program, worrisome features warrant for intensified surveillance or, occasionally, surgery. Our objectives were to determine the patient-reported burden of intensified surveillance and/or surgery, and to assess post-operative quality of life and opinion of surgery. Participants in our pancreatic cancer surveillance program completed questionnaires including the Cancer Worry Scale (CWS) and the Hospital Anxiety and Depression Scale (HADS). For individuals who underwent intensified surveillance, questionnaires before, during, and ≥ 3 weeks after were analyzed. In addition, subjects who underwent intensified surveillance in the past 3 years or underwent surgery at any time, were invited for an interview, that included the Short-Form 12 (SF-12). A total of 31 high-risk individuals were studied. During the intensified surveillance period, median CWS scores were higher (14, IQR 7), as compared to before (12, IQR 9, P = 0.007) and after (11, IQR 7, P = 0.014), but eventually returned back to baseline (P = 0.823). Median HADS scores were low: 5 (IQR 6) for anxiety and 3 (IQR 5) for depression, and they were unaffected by the intensified surveillance period. Of the 10 operated patients, 1 (10%) developed diabetes and 7 (70%) pancreatic exocrine insufficiency. The interviews yielded median quality-of-life scores comparable to the general population. Also, after surgery, patients' attitudes towards surveillance were unchanged (5/10, 50%) or became more positive (4/10, 40%). Although patients were aware of the (sometimes benign) pathological outcome, when asked if surgery had been justified, only 20% (2/10) disagreed, and all would again have chosen to undergo surgery. In conclusion, in individuals at high risk for pancreatic cancer, intensified surveillance temporarily increased cancer worries, without affecting general anxiety or depression. Although pancreatic surgery led to substantial co-morbidity, quality of life was similar to the general population, and surgery did not negatively affect the attitude towards surveillance.
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http://dx.doi.org/10.1007/s10689-020-00171-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242488PMC
July 2020

Methods and outcome of the endoscopic treatment of ampullary tumors.

Ther Adv Gastrointest Endosc 2020 Jan-Dec;13:2631774519899786. Epub 2020 Jan 21.

Gastroenterology & Hepatology, Erasmus MC, Rotterdam, The Netherlands.

Ampullary tumors are rare neoplasms but increasingly encountered due to an increase in diagnostic procedures, mainly upper gastrointestinal endoscopy. Diagnosis, staging, and treatment of these tumors are described and recommendations given based on the most recent literature.
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http://dx.doi.org/10.1177/2631774519899786DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6977234PMC
January 2020

Diagnostic yield and agreement on fine-needle specimens from solid pancreatic lesions : comparing the smear technique to liquid-based cytology.

Endosc Int Open 2020 Feb 22;8(2):E155-E162. Epub 2020 Jan 22.

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

 The traditional "smear technique" for processing and assessing endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is sensitive to artifacts. Processing and evaluation of specimens collected in a liquid medium, liquid-based cytology (LBC) may be a solution. We compared the diagnostic value of EUS-FNA smears to LBC in pancreatic solid lesions in the absence of rapid on-site evaluation (ROSE). Consecutive patients who required EUS-FNA of a solid pancreatic lesion were included in seven hospitals in the Netherlands and followed for at least 12 months. Specimens from the first pass were split into two smears and a vial for LBC (using ThinPrep and/or Cell block). Smear and LBC were compared in terms of diagnostic accuracy for malignancy, sample quality, and diagnostic agreement between three cytopathologists. Diagnostic accuracy for malignancy was higher for LBC (82 % (58/71)) than for smear (66 % (47/71),  = 0.04), but did not differ when smears were compared to ThinPrep (71 % (30/42),  = 0.56) or Cell block (62 % (39/63),  = 0.61) individually. Artifacts were less often present in ThinPrep (57 % (24/42),  = 0.02) or Cell block samples (40 % (25/63),  < 0.001) than smears (76 % (54/71)). Agreement on malignancy was equally good for smears and LBC (ĸ = 0.71 versus ĸ = 0.70,  = 0.98), but lower for ThinPrep (ĸ = 0.26,  = 0.01) than smears. After a single pass, LBC provides higher diagnostic accuracy than the conventional smear technique for EUS-FNA of solid pancreatic lesions in the absence of ROSE. Therefore, LBC, may be an alternative to the conventional smear technique, especially in centers lacking ROSE.
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http://dx.doi.org/10.1055/a-1038-4103DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6976322PMC
February 2020

Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis: The ESCAPE Randomized Clinical Trial.

JAMA 2020 01;323(3):237-247

Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Importance: For patients with painful chronic pancreatitis, surgical treatment is postponed until medical and endoscopic treatment have failed. Observational studies have suggested that earlier surgery could mitigate disease progression, providing better pain control and preserving pancreatic function.

Objective: To determine whether early surgery is more effective than the endoscopy-first approach in terms of clinical outcomes.

Design, Setting, And Participants: The ESCAPE trial was an unblinded, multicenter, randomized clinical superiority trial involving 30 Dutch hospitals participating in the Dutch Pancreatitis Study Group. From April 2011 until September 2016, a total of 88 patients with chronic pancreatitis, a dilated main pancreatic duct, and who only recently started using prescribed opioids for severe pain (strong opioids for ≤2 months or weak opioids for ≤6 months) were included. The 18-month follow-up period ended in March 2018.

Interventions: There were 44 patients randomized to the early surgery group who underwent pancreatic drainage surgery within 6 weeks after randomization and 44 patients randomized to the endoscopy-first approach group who underwent medical treatment, endoscopy including lithotripsy if needed, and surgery if needed.

Main Outcomes And Measures: The primary outcome was pain, measured on the Izbicki pain score and integrated over 18 months (range, 0-100 [increasing score indicates more pain severity]). Secondary outcomes were pain relief at the end of follow-up; number of interventions, complications, hospital admissions; pancreatic function; quality of life (measured on the 36-Item Short Form Health Survey [SF-36]); and mortality.

Results: Among 88 patients who were randomized (mean age, 52 years; 21 (24%) women), 85 (97%) completed the trial. During 18 months of follow-up, patients in the early surgery group had a lower Izbicki pain score than patients in the group randomized to receive the endoscopy-first approach group (37 vs 49; between-group difference, -12 points [95% CI, -22 to -2]; P = .02). Complete or partial pain relief at end of follow-up was achieved in 23 of 40 patients (58%) in the early surgery vs 16 of 41 (39%)in the endoscopy-first approach group (P = .10). The total number of interventions was lower in the early surgery group (median, 1 vs 3; P < .001). Treatment complications (27% vs 25%), mortality (0% vs 0%), hospital admissions, pancreatic function, and quality of life were not significantly different between early surgery and the endoscopy-first approach.

Conclusions And Relevance: Among patients with chronic pancreatitis, early surgery compared with an endoscopy-first approach resulted in lower pain scores when integrated over 18 months. However, further research is needed to assess persistence of differences over time and to replicate the study findings.

Trial Registration: ISRCTN Identifier: ISRCTN45877994.
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http://dx.doi.org/10.1001/jama.2019.20967DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990680PMC
January 2020

Endoscopic ultrasound and fine-needle aspiration for the detection of residual nodal disease after neoadjuvant chemoradiotherapy for esophageal cancer.

Endoscopy 2020 03 9;52(3):186-192. Epub 2019 Dec 9.

Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.

Background: Endoscopic ultrasound (EUS) and fine-needle aspiration (FNA) are potential tools for the detection of residual disease after neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer. This study investigated yield of EUS and FNA for detection of malignant lymph nodes (LNs) after nCRT.

Methods: This was a post hoc analysis of the preSANO trial. EUS was performed 10 - 12 weeks after nCRT. 18F-fluorodeoxyglucose positron emission tomography - computed tomography (F-FDG PET-CT) was used to guide targeting of suspicious LNs. Consecutive FNA sampling was performed for suspicious LNs identified on EUS and/or PET-CT. EUS nodal staging was compared with histopathological examination of the resection specimen. The primary outcome was the proportion of correctly identified patients with malignant LNs by radial EUS.

Results: 101 consecutive patients were included: 79 patients had no malignant LNs, of whom 62 were classified correctly by EUS (specificity 78 %); 22 patients had malignant LNs, of whom 11 were identified (sensitivity 50 %). Six of these patients had ≥ 1 suspicious LN not fulfilling EUS criteria (round, hypoechogenic, > 5 mm). Malignant LNs in falsely negative patients were predominantly located at distal LN stations. Specificity and sensitivity of conclusive FNA outcomes were 100 % (7/7) and 75 % (3/4), respectively. FNA outcome was uncertain in eight patients, half of whom appeared to have malignant LNs.

Conclusions: EUS only detected 50 % of patients with malignant LNs 10 - 12 weeks after nCRT. To optimize sensitivity and minimize the risk of missing residual disease, FNA of LNs should be performed even in cases of low endosonographic suspicion.
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http://dx.doi.org/10.1055/a-1065-1759DOI Listing
March 2020

The role of EUS in diagnosis and treatment of liver disorders.

Endosc Int Open 2019 Oct 1;7(10):E1262-E1275. Epub 2019 Oct 1.

Department of Gastroenterology and Hepatology, Erasmus MC, The Netherlands.

 Transabdominal ultrasound (US), computed tomographic scanning (CT) and magnetic resonance imaging (MRI) are established diagnostic tools for liver diseases. Percutaneous transhepatic cholangiography is used to perform hepatic interventional procedures including biopsy, biliary drainage procedures, and radiofrequency ablation. Despite their widespread use, these techniques have limitations. Endoscopic ultrasound (EUS), a tool that has proven useful for evaluating the mediastinum, esophagus, stomach, pancreas, and biliary tract, has an expanding role in the field of hepatology complementing the traditional investigational modalities. This review aimed to assess the current scientific evidence regarding diagnostic and therapeutic applications of EUS for hepatic diseases.
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http://dx.doi.org/10.1055/a-0958-2183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6773586PMC
October 2019

An international, multi-institution survey of the use of EUS in the diagnosis of pancreatic cystic lesions.

Endosc Ultrasound 2019 Nov-Dec;8(6):418-427

Endoscopy Center, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China.

Background And Objectives: Currently, pancreatic cystic lesions (PCLs) are recognized with increasing frequency and have become a more common finding in clinical practice. EUS is challenging in the diagnosis of PCLs and evidence-based decisions are lacking in its application. This study aimed to develop strong recommendations for the use of EUS in the diagnosis of PCLs, based on the experience of experts in the field.

Methods: A survey regarding the practice of EUS in the evaluation of PCLs was drafted by the committee member of the International Society of EUS Task Force (ISEUS-TF). It was disseminated to experts of EUS who were also members of the ISEUS-TF. In some cases, percentage agreement with some statements was calculated; in others, the options with the greatest numbers of responses were summarized.

Results: Fifteen questions were extracted and disseminated among 60 experts for the survey. Fifty-three experts completed the survey within the specified time frame. The average volume of EUS cases at the experts' institutions is 988.5 cases per year.

Conclusion: Despite the limitations of EUS alone in the morphologic diagnosis of PCLs, the results of the survey indicate that EUS-guided fine-needle aspiration is widely expected to become a more valuable method.
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http://dx.doi.org/10.4103/eus.eus_61_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6927137PMC
September 2019

Interobserver agreement among expert pathologists on through-the-needle microforceps biopsy samples for evaluation of pancreatic cystic lesions.

Gastrointest Endosc 2019 11 16;90(5):784-792.e4. Epub 2019 Jul 16.

Pathology Unit, Azienda USL Città di Bologna, Ospedale Maggiore, Bologna, Italy.

Background And Aims: The recent development of microforceps for EUS through-the-needle biopsy (TTNB) sampling of the wall of pancreatic cystic lesions (PCLs) allows the collection of histologic specimens never handled and evaluated before by pathologists. We aimed to estimate the interobserver agreement among pathologists in evaluating such samples.

Methods: TTNB specimen slides from 40 PCLs with worrisome features were retrieved and independently evaluated for specimen adequacy, presence of lining epithelium, grade of epithelial dysplasia, presence of ovarian type stroma, and specific diagnosis by 6 expert pathologists from 6 different tertiary care centers. The Gwet's AC1 was used to assess interobserver agreement.

Results: An almost perfect agreement was observed for specimen adequacy (AC1, .82; 95% confidence interval [CI], .79-.98), presence of lesional epithelium (AC1, .90; 95% CI, .86-.92), epithelial dysplasia (AC1, .97; 95% CI, .95-.99), and ovarian-like stroma (AC1, .90; 95% CI, .86-.93). When considering all diagnoses separately, a moderate to substantial agreement was observed (AC1, .62; 95% CI, .57-.67), similarly to mucinous cysts versus serous adenoma versus other diagnoses (AC1, .65; 95% CI, .59-.70) and for mucinous cysts versus all other diagnoses (AC1,.74; 95% CI, .68-.84). The agreement for diagnosis of mucinous cystic neoplasm versus intraductal mucinous papillary neoplasm was almost perfect (AC1, .88; 95% CI, .81-.95).

Conclusions: Interobserver agreement between expert pathologists in the evaluation of TTNB samples from PCLs with worrisome features was close to perfection for all evaluated parameters, except definitive diagnosis. When mucinous cystic lesions were compared versus all other diagnoses, the agreement became substantial, thus indicating that TTNB specimens can provide important information for PCL management decisions.
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http://dx.doi.org/10.1016/j.gie.2019.07.011DOI Listing
November 2019

EUS-FNB with or without on-site evaluation for the diagnosis of solid pancreatic lesions (FROSENOR): Protocol for a multicenter randomized non-inferiority trial.

Dig Liver Dis 2019 06 8;51(6):901-906. Epub 2019 Apr 8.

Digestive Endoscopy Unit, University Hospital A. Gemelli, IRCCS, Roma, Italy.

Background: Rapid on-site evaluation (ROSE) of cytological specimensacquired with EUS-guided fine needle aspiration (EUS-FNA) represents the most accurate available technique to reach a definitive diagnosis in patients with pancreatic solid masses. Recently, needles with high histological yield have been developed for EUS-guided fine needle biopsy (EUS-FNB), with which the need for ROSE can be potentially overcome.

Aims: The primary aim is to compare the diagnostic accuracy of EUS-FNB with or without ROSE. The main endpoint will be measured against the gold standard diagnosis (surgical pathology whenever available or diagnostic work-up in agreement with a clinical course of at least six months). Secondary endpoints include: (a) safety; (b) presence of tissue core; (c) quality of specimens; (d) time of the sampling procedure. Reliability of macroscopic on-site evaluation (MOSE) by endosonographers will be also assessed.

Methods: FROSENOR is an international randomized non-inferiority ongoing study at sixteen centers in four continents. Eight hundred patients will be randomized in two arms (EUS-FNB + ROSE vs. EUS-FNB alone) and outcomes compared. Sample size has been calculated in order to demonstrate the non-inferiority of FNB alone. Randomization and data collection will be performed online.

Discussion: This study will ascertain if ROSE is still needed when performing EUS-FNB of solid pancreatic lesions.
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http://dx.doi.org/10.1016/j.dld.2019.03.008DOI Listing
June 2019

Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Updated August 2018.

Endoscopy 2019 02 17;51(2):179-193. Epub 2019 Jan 17.

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

ESGE suggests endoscopic therapy and/or extracorporeal shockwave lithotripsy (ESWL) as the first-line therapy for painful uncomplicated chronic pancreatitis (CP) with an obstructed main pancreatic duct (MPD) in the head/body of the pancreas. The clinical response should be evaluated at 6 - 8 weeks; if it appears unsatisfactory, the patient's case should be discussed again in a multidisciplinary team and surgical options should be considered.Weak recommendation, low quality evidence.ESGE suggests, for the selection of patients for initial or continued endoscopic therapy and/or ESWL, taking into consideration predictive factors associated with a good long-term outcome. These include, at initial work-up, absence of MPD stricture, a short disease duration, non-severe pain, absence or cessation of cigarette smoking and of alcohol intake, and, after initial treatment, complete removal of obstructive pancreatic stones and resolution of pancreatic duct stricture with stenting.Weak recommendation, low quality evidence.ESGE recommends ESWL for the clearance of radiopaque obstructive MPD stones larger than 5 mm located in the head/body of the pancreas and endoscopic retrograde cholangiopancreatography (ERCP) for MPD stones that are radiolucent or smaller than 5 mm. Strong recommendation, moderate quality evidence.ESGE suggests restricting the use of endoscopic therapy after ESWL to patients with no spontaneous clearance of pancreatic stones after adequate fragmentation by ESWL.Weak recommendation, moderate quality evidence.ESGE suggests treating painful dominant MPD strictures with a single 10-Fr plastic stent for one uninterrupted year if symptoms improve after initial successful MPD drainage. The stent should be exchanged if necessary, based on symptoms or signs of stent dysfunction at regular pancreas imaging at least every 6 months. ESGE suggests consideration of surgery or multiple side-by-side plastic stents for symptomatic MPD strictures persisting beyond 1 year after the initial single plastic stenting, following multidisciplinary discussion. Weak recommendation, low quality evidence.ESGE recommends endoscopic drainage over percutaneous or surgical treatment for uncomplicated chronic pancreatitis (CP)-related pseudocysts that are within endoscopic reach.Strong recommendation, moderate quality evidence.ESGE recommends retrieval of transmural plastic stents at least 6 weeks after pancreatic pseudocyst regression if MPD disruption has been excluded, and long-term indwelling of transmural double-pigtail plastic stents in patients with disconnected pancreatic duct syndrome.Strong recommendation, low quality evidence.ESGE suggests the temporary insertion of multiple side-by-side plastic stents or of a fully covered self-expandable metal stent (FCSEMS) for treating CP-related benign biliary strictures.Weak recommendation, moderate quality evidence.ESGE recommends maintaining a registry of patients with biliary stents and recalling them for stent removal or exchange.Strong recommendation, low quality evidence.
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http://dx.doi.org/10.1055/a-0822-0832DOI Listing
February 2019

Performance measures for endoscopic retrograde cholangiopancreatography and endoscopic ultrasound: A European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

United European Gastroenterol J 2018 Dec 19;6(10):1448-1460. Epub 2018 Oct 19.

Northern Institute for Cancer Research, Newcastle University, Newcastle, UK.

The European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology present a short list of key performance measures for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP). We recommend that endoscopy services across Europe adopt the following seven key and one minor performance measures for EUS and ERCP, for measurement and evaluation in daily practice at centre and endoscopist level: Adequate antibiotic prophylaxis before ERCP (key performance measure, at least 90%); antibiotic prophylaxis before EUS-guided puncture of cystic lesions (key performance measure, at least 95%); bile duct cannulation rate (key performance measure, at least 90%); tissue sampling during EUS (key performance measure, at least 85%); appropriate stent placement in patients with biliary obstruction below the hilum (key performance measure, at least 95%); bile duct stone extraction (key performance measure, at least 90%); post-ERCP pancreatitis (key performance measure, less than 10%); and adequate documentation of EUS landmarks (minor performance measure, at least 90%). This present list of quality performance measures for ERCP and EUS recommended by the ESGE should not be considered to be exhaustive; it might be extended in future to address further clinical and scientific issues.
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http://dx.doi.org/10.1177/2050640618808157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6297928PMC
December 2018

A multi-institution consensus on how to perform EUS-guided biliary drainage for malignant biliary obstruction.

Endosc Ultrasound 2018 Nov-Dec;7(6):356-365

Endoscopy Center, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China.

Background And Objectives: EUS-guided biliary drainage (EUS-BD) was shown to be useful for malignant biliary obstruction (MBO). However, there is lack of consensus on how EUS-BD should be performed.

Methods: This was a worldwide multi-institutional survey among members of the International Society of EUS conducted in February 2018. The survey consisted of 10 questions related to the practice of EUS-BD.

Results: Forty-six endoscopists of them completed the survey. The majority of endoscopists felt that EUS-BD could replace percutaneous transhepatic biliary drainage after failure of ERCP. Among all EUS-BD methods, the rendezvous stenting technique should be the first choice. Self-expandable metal stents (SEMSs) were recommended by most endoscopists. For EUS-guided hepaticogastrostomy (HGS), superiority of partially-covered SEMS over fully-covered SEMS was not in agreement. 6-Fr cystotomes were recommended for fistula creation. During the HGS approach, longer SEMS (8 or 10 cm) was recommended. During the choledochoduodenostomy approach, 6-cm SEMS was recommended. During the intrahepatic (IH) approach, the IH segment 3 was recommended.

Conclusion: This is the first worldwide survey on the practice of EUS-BD for MBO. There were wide variations in practice, and randomized studies are urgently needed to establish the best approach for the management of this condition.
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http://dx.doi.org/10.4103/eus.eus_53_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6289007PMC
December 2018

A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device.

Gastrointest Endosc 2019 02 24;89(2):329-339. Epub 2018 Oct 24.

Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.

Background And Aims: Several studies have compared EUS-guided FNA with fine-needle biopsy (FNB), but none have proven superiority. We performed a multicenter randomized controlled trial to compare the performance of a commonly used 25-gauge FNA needle with a newly designed 20-gauge FNB needle.

Methods: Consecutive patients with a solid lesion were randomized in this international multicenter study between a 25-gauge FNA (EchoTip Ultra) or a 20-gauge FNB needle (ProCore). The primary endpoint was diagnostic accuracy for malignancy and the Bethesda classification (non-diagnostic, benign, atypical, malignant). Technical success, safety, and sample quality were also assessed. Multivariable and supplementary analyses were performed to adjust for confounders.

Results: A total of 608 patients were allocated to FNA (n = 306) or FNB (n = 302); 312 pancreatic lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Technical success rate was 100% for the 25-gauge FNA and 99% for the 20-gauge FNB needle (P = .043), with no differences in adverse events. The 20-gauge FNB needle outperformed 25-gauge FNA in terms of histologic yield (77% vs 44%, P < .001), accuracy for malignancy (87% vs 78%, P = .002) and Bethesda classification (82% vs 72%, P = .002). This was robust when corrected for indication, lesion size, number of passes, and presence of an on-site pathologist (odds ratio, 3.53; 95% confidence interval, 1.55-8.56; P = .004), and did not differ among centers (P = .836).

Conclusion: The 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histologic yield and diagnostic accuracy. This benefit was irrespective of the indication and was consistent among participating centers, supporting the general applicability of our findings. (Clinical trial registration number: NCT02167074.).
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http://dx.doi.org/10.1016/j.gie.2018.10.026DOI Listing
February 2019

Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

Endoscopy 2018 11 19;50(11):1116-1127. Epub 2018 Oct 19.

Northern Institute for Cancer Research, Newcastle University, Newcastle, United Kingdom.

The European Society of Gastrointestinal Endoscopy and United European Gastroenterology present a short list of key performance measures for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP). We recommend that endoscopy services across Europe adopt the following seven key and one minor performance measures for EUS and ERCP, for measurement and evaluation in daily practice at center and endoscopist level: 1: Adequate antibiotic prophylaxis before ERCP (key performance measure, at least 90 %); 2: Antibiotic prophylaxis before EUS-guided puncture of cystic lesions (key performance measure, at least 95 %); 3: Bile duct cannulation rate (key performance measure, at least 90 %); 4: Tissue sampling during EUS (key performance measure, at least 85 %); 5: Appropriate stent placement in patients with biliary obstruction below the hilum (key performance measure, at least 95 %); 6: Bile duct stone extraction (key performance measure, at least 90 %); 7: Post-ERCP pancreatitis (key performance measure, less than 10 %). 8: Adequate documentation of EUS landmarks (minor performance measure, at least 90 %).This present list of quality performance measures for ERCP and EUS recommended by ESGE should not be considered to be exhaustive: it might be extended in future to address further clinical and scientific issues.
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http://dx.doi.org/10.1055/a-0749-8767DOI Listing
November 2018

Protocol for the STRONG trial: stereotactic body radiation therapy following chemotherapy for unresectable perihilar cholangiocarcinoma, a phase I feasibility study.

BMJ Open 2018 10 15;8(10):e020731. Epub 2018 Oct 15.

Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.

Introduction: For patients with perihilar cholangiocarcinoma (CCA), surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients, the tumours are found to be unresectable at presentation due to either local invasive tumour growth or the presence of distant metastases. For patients with unresectable CCA, palliative chemotherapy is the standard treatment yielding an estimated median overall survival (OS) of 12-15.2 months. There is no evidence from randomised trials to support the use of stereotactic body radiation therapy (SBRT) for CCA. However, small and most often retrospective studies combining chemotherapy with SBRT have shown promising results with OS reaching up to 33-35 months.

Methods And Analysis: This study has been designed as a single-centre phase I feasibility trial and will investigate the addition of SBRT after standard chemotherapy in patients with unresectable perihilar CCA (T1-4 N0-1 M0). A total of six patients will be included. SBRT will be delivered in 15 fractions of 3-4.5 Gy (risk adapted). The primary objective of this study is to determine feasibility and toxicity. Secondary outcomes include local tumour control, progression-free survival (PFS), OS and quality of life. Length of follow-up will be 2 years. As an ancillary study, the personalised effects of radiotherapy will be measured in vitro, in patient-derived tumour and bile duct organoid cultures.

Ethics And Dissemination: Ethics approval for the STRONG trial has been granted by the Medical Ethics Committee of Erasmus MC Rotterdam, the Netherlands. It is estimated that all patients will be included between October 2017 and October 2018. The results of this study will be published in a peer-reviewed journal, and presented at national and international conferences.

Trial Registration Number: NCT03307538; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2017-020731DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6196820PMC
October 2018

Endoscopic resection of advanced ampullary adenomas: a single-center 14-year retrospective cohort study.

Surg Endosc 2019 04 23;33(4):1180-1188. Epub 2018 Aug 23.

Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, Postbus 2040, 3000 CA, Rotterdam, The Netherlands.

Background: Endoscopic ampullectomy has been recognized as a safe and reliable means to resect selective tumors of the ampulla of Vater and is associated with lower morbidity and mortality rates compared to surgical resection. Success rates range from 42 to 92%, with recurrences reported in up to 33%. Studies on endoscopic resection of advanced lesions such as those with intraductal extension of adenoma (IEA) and lateral spreading adenomas (LSA) are limited. We aimed to evaluate the technical success, complications, and recurrence of endoscopic resection of ampullary adenomas, including advanced lesions.

Methods: All patients referred to the Erasmus Medical Center for endoscopic resection of an ampullary lesion were retrospectively identified between 2002 and 2016. Endoscopic success was defined as complete excision of the adenoma, irrespective of the number of attempts, in the absence of recurrence.

Results: We included 87 patients with a median age of 65 years. Of these, 56 patients (64%) had an adenoma confined to the ampulla (ACA), 20 patients (23%) had an LSA, and 11 patients (13%) were treated for an IEA. The median lesion sizes were 24.6 mm, 41.4 mm, and 16.3 mm, respectively (P < 0.001). Complications occurred in 22 patients (25.3%), of which hemorrhage was most prevalent (12.6%), followed by perforation (8.1%). Complications were equally divided (P = 0.874). The median follow-up duration was 21.1 months (12-45.9) for ACA, 14.7 months (4.2-34.5) for LSA, and 5.8 months (3.7-22.0) for IEA (P = 0.051). Endoscopic resection was curative in 87.5% of patients with an ACA, 85% in patients with an LSA, and in only one patient with an IEA (P < 0.001). Recurrence occurred in 10 patients (11.5%) (P = 0.733).

Conclusion: Endoscopic ampullectomy is safe and highly successful in selected patients with an adenoma with or without lateral spreading. Outcomes of endoscopic treatment adenomas with an intraductal extension are less favorable and in these cases surgery should be considered.
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http://dx.doi.org/10.1007/s00464-018-6392-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6430826PMC
April 2019