Endoscopic papillectomy for ampullary lesions of minor papilla.

BACKGROUND AND AIMS: Ampullary lesions (ALs) of the minor duodenal papilla are extremely rare. Endoscopic papillectomy (EP) is a routinely used treatment for AL of the major duodenal papilla, but the role of EP for minor AL has not been accurately studied. METHODS: We identified 20 patients with ALs of minor duodenal papilla in the multicentric database from the Endoscopic Papillectomy vs Surgical Ampullectomy vs Pancreatitcoduodenectomy for Ampullary Neoplasm study, which included 1422 EPs. We used propensity score matching (nearest-neighbor method) to match these cases with ALs of the major duodenal papilla based on age, sex, histologic subtype, and size of the lesion in a 1:2 ratio. Cohorts were compared by means of chi-square or Fisher exact test as well as Mann-Whitney U test. RESULTS: Propensity score-based matching identified a cohort of 60 (minor papilla 20, major papilla 40) patients with similar baseline characteristics. The most common histologic subtype of lesions of minor papilla was an ampullary adenoma in 12 patients (3 low-grade dysplasia and 9 high-grade dysplasia). Five patients revealed nonneoplastic lesions. Invasive cancer (T1a), adenomyoma, and neuroendocrine neoplasia were each found in 1 case. The rate of complete resection, en-bloc resection, and recurrences were similar between the groups. There were no severe adverse events after EP of lesions of minor papilla. One patient had delayed bleeding that could be treated by endoscopic hemostasis, and 2 patients showed a recurrence in surveillance endoscopy after a median follow-up of 21 months (interquartile range, 12-50 months). CONCLUSIONS: EP is safe and effective in ALs of the minor duodenal papilla. Such lesions could be managed according to guidelines for EP of major duodenal papilla.

Long-term outcomes of pancreatoscopy-guided electrohydraulic lithotripsy for the treatment of obstructive pancreatic duct stones.

Background and study aims Pancreatoscopy-guided electrohydraulic lithotripsy (EHL) has proven to be an effective first-line therapy in symptomatic chronic pancreatitis (CP) patients with obstructing pancreatic duct (PD) stones 1 . However, long-term outcomes of endoscopic EHL remain unknown. The aim of the present study was to evaluate the long-term treatment effects of EHL as first-line therapy and to compare with those obtained in a historical cohort of patients who underwent extracorporeal shockwave lithotripsy (ESWL) as primary treatment. Patients and methods An observational retrospective single-center long-term follow-up study was performed including 19 consecutive patients who previously underwent endoscopic EHL compared to 18 patients who underwent ESWL followed by endoscopic retrograde pancreatography (ERP). The primary endpoint was long-term treatment success after EHL or ESWL defined as no recurrence of symptomatic intraductal stones confirmed on imaging. Secondary endpoints for the EHL-population included long-term clinical success (i. e., a similar or lower Izbicki Pain Score or reduction in opiate usage as compared to 6-month follow-up), quality of life (QoL), pancreatic function and hospital re-admission rate. Results In the EHL group, 37 % of the patients developed recurrent symptomatic PD stones versus 61 % in the ESWL group after a median follow-up of 35.0 and 76.5 months. Of the patients with recurrence, 71 % versus 100 % underwent a reintervention. Median time to recurrence was 12.0 versus 13.0 months. Clinical success sustained in 58 % of the EHL patients. QoL was not significantly different compared with 6-month follow-up and baseline. Conclusions Also at long-term follow-up, endoscopic EHL as first-line treatment is moderately effective for symptomatic CP patients with treatment success rates that seems at least equally effective as ESWL.

Endoscopic papillectomy for ampullary lesions in patients with familial adenomatous polyposis compared with sporadic lesions: a propensity score-matched cohort.

BACKGROUND: Familial adenomatous polyposis (FAP) is a rare inherited syndrome that predisposes the patient to cancer. Treatment of FAP-related ampullary lesions is challenging and the role of endoscopic papillectomy has not been elucidated. We retrospectively analyzed the outcomes of endoscopic papillectomy in matched cohorts of FAP-related and sporadic ampullary lesions (SALs). METHODS: This retrospective multicenter study included 1422 endoscopic papillectomy procedures. Propensity score matching including age, sex, comorbidity, histologic subtype, and size was performed. Main outcomes were complete resection (R0), technical success, complications, and recurrence. RESULTS: Propensity score matching identified 202 patients (101 FAP, 101 SAL) with comparable baseline characteristics. FAP patients were mainly asymptomatic (79.2 % [95 %CI 71.2-87.3] vs. 46.5 % [95 %CI 36.6-56.4]); P < 0.001). The initial R0 rate was significantly lower in FAP patients (63.4 % [95 %CI 53.8-72.9] vs. 83.2 % [95 %CI 75.8-90.6]; P = 0.001). After repeated interventions (mean 1.30 per patient), R0 was comparable (FAP 93.1 % [95 %CI 88.0-98.1] vs. SAL 97.0 % [95 %CI 93.7-100]; P = 0.19). Adverse events occurred in 28.7 %. Pancreatitis and bleeding were the most common adverse events in both groups. Severe adverse events were rare (3.5 %). Overall, 21 FAP patients (20.8 % [95 %CI 12.7-28.8]) and 16 SAL patients (15.8 % [95 %CI 8.6-23.1]; P = 0.36) had recurrence. Recurrences occurred later in FAP patients (25 [95 %CI 18.3-31.7] vs. 2 [95 %CI CI 0.06-3.9] months). CONCLUSIONS: Endoscopic papillectomy was safe and effective in FAP-related ampullary lesions. Criteria for endoscopic resection of ampullary lesions can be extended to FAP patients. FAP patients have a lifetime risk of relapse even after complete resection, and require long-time surveillance.

Implementation of mandatory ERCP registration in The Netherlands and compliance with European Society of Gastrointestinal Endoscopy performance measures: a multicenter database study.

BACKGROUND: In 2018, the European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology (UEG) published quality performance measures for endoscopic retrograde cholangiopancreatography (ERCP). Since January 2016, all endoscopists in the Netherlands have been required to register all ERCP procedures in a nationwide quality registry. This study aimed to evaluate the procedural success rates of ERCP after the implementation of mandatory national registration and to compare these with the ESGE quality performance measures. METHODS: This study was conducted with data from a multicenter endoscopy database. Data from 2019 and 2020 were analyzed. The primary outcome was ERCP procedural outcome. ESGE performance measures that could be evaluated were the percentage of successful bile duct cannulations in patients with virgin papillary anatomy; successful stent placement for a biliary obstruction located below the liver hilum; and complete removal of bile duct stones (< 10 mm). RESULT: In total, 5295 ERCPs performed in 11 centers were included for analysis. The overall procedural success rate was 89.1 %. Successful biliary cannulation in patients with a virgin papilla was 90.3 % in nonacademic and 92.4 % in academic centers. The rates of successful stent placement in patients with a biliary obstruction located below the liver hilum were 97.0 % in nonacademic and 98.2 % in academic centers, and of successful bile duct stone extraction were 97.9 % in both nonacademic and academic centers. CONCLUSIONS: The quality of ERCPs performed met five of the six evaluated ESGE performance measures. The 95 % target for successful biliary cannulation in patients with virgin papillary anatomy in academic centers was not met. Mandatory registration provides valuable insight into ERCP performance rates.

Pancreatoscopy-guided electrohydraulic lithotripsy for the treatment of obstructive pancreatic duct stones: a prospective consecutive case series.

BACKGROUND AND AIMS: Pancreatoscopy-guided electrohydraulic lithotripsy (EHL) has shown potential in the treatment of patients with obstructive chronic calcifying pancreatitis (CCP). We aimed to prospectively investigate the efficacy and safety of EHL as first-line therapy in patients with CCP of the pancreatic duct (PD). METHODS: A prospective single-center consecutive case series was performed including symptomatic CCP patients with obstructing stones >5 mm in the head or neck of the pancreas. Stone fragmentation was performed using EHL. Primary study outcome was technical success. Secondary outcomes were clinical success, adverse events, and number of interventions. RESULTS: Thirty-four consecutive patients were included. Complete or partial stone clearance after EHL was achieved in 24 patients (70.6%). Pancreatoscopy was not performed because of failure to cannulate the PD (n = 5) or resolution of stones after stent placement at the index endoscopic retrograde pancreaticography (ERP) procedure (n = 3). After successful PD cannulation, pancreatoscopy was technically successful in 24 of 26 patients (92.3%). In 1 patient, the stone could not be visualized because of a resilient stricture. Complete stone clearance was achieved in 20 patients (80%) and partial clearance in 5 patients (20%), after a median of 2 ERP procedures (interquartile range, 2) and 1 EHL procedure (interquartile range, 1). In patients who underwent pancreatoscopy with EHL, mean Izbicki pain score at baseline was 62.3 ± 23.1 (25/25) and dropped significantly to 27.5 ± 35.0 (22/25) at the 6-month follow-up (P < .001). The most common adverse event was acute pancreatitis, all mild and treated conservatively (n = 7). CONCLUSIONS: Pancreatoscopy-guided EHL is a promising treatment for symptomatic CCP patients with obstructive PD stones. (Clinical trial registration number: NTR6853.).

Face validity of a synthetic papilla designed for biliary sphincterotomy training.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is considered one of the most technically demanding endoscopic procedures. Still, limited data are available on simulators in ERCP training. Recently, the Boskoski-Costamagna ERCP Trainer was validated as a realistic training model by our study group. As an extension to this model, a novel synthetic papilla has been designed allowing to train biliary sphincterotomy. We aimed to determine the face validity of this synthetic papilla and its didactic value for training sphincterotomy. Methods Expert participants, each with more a than 2500 ERCPs lifetime experience, were invited to perform a biliary sphincterotomy and fill out a questionnaire on the realism of the procedure and the didactic value. Results A total of 40 ERCP experts were included, originating from 16 different countries. Experts' opinion on realism of performing a biliary sphincterotomy was rated with a median of 7 on a 10-point Likert scale, resemblance of the performed maneuvers 8 and tactile feedback 7. When asked if the cutting was perceived as realistic, experts rated a 6 and the cutting result was rated 8. The potential of the cutting papilla as a training tool for novices was rated 4 on a 4-point scale and there was a high agreement among the experts to include the papilla in the training of novices (rating 4). Conclusion This is the first synthetic papilla available for training sphincterotomy on the Boskoski-Costamagna ERCP Trainer and it demonstrates good face validity. ERCP experts highly agree on its didactic value and added value in the training curriculum of novice endoscopists.

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

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.

Face and construct validity of a novel mechanical ERCP simulator.

BACKGROUND AND STUDY AIMS: Simulation-based training has become an important pillar in competence-based medicine. However, limited data are available on use of simulators in training for endoscopic retrograde cholangiopancreatography (ERCP). We aimed to determine the face and construct validity of the Boskoski-Costamagna mechanical ERCP Trainer, and to assess its didactic value, as judged by experts. METHODS: Participants were divided into four groups based on ERCP lifetime experience: novices, intermediate, experienced, and experts. Participants performed several standardized assignments on the simulator. Outcome parameters included times to complete the procedure, ability to cannulate both ducts, number of attempts to cannulate the common bile duct and pancreatic duct, number of inadvertent pancreatic duct cannulations, successful stent placement, and successful stone extraction. All experts filled out a questionnaire on the simulator's realism and didactic value. RESULTS: Novices (n = 11) completed the total procedure in 21:09 (min:sec), intermediates (n = 5) in 10:58, experienced (n = 8) in 06:42 and experts (n = 22) in 06:05. Experts were significantly faster than novices (Kruskal-Wallis test P  < 0.000). Experts rated the realism of the simulator 7.12 on a 10-point Likert scale. The simulator's potential as a tool for training novices was rated 3.91 on a four-point Likert scale, and there was a high agreement among experts to include the simulator in the training of novice endoscopists (3.86 on a four-point Likert scale). CONCLUSIONS: The novel Boskoski-Costamagna ERCP simulator demonstrates good face and construct validity. ERCP experts highly agree on the didactic value and added value of this simulator in the training curriculum for novice endoscopists.