Subscribe to RSS
Effect of prophylactic endoscopic clipping for prevention of delayed bleeding after endoscopic papillectomy for ampullary neoplasm: a multicenter randomized trialTrial Registration: Clinical Research Information Service, Republic of Korea (https://cris.nih.go.kr) Registration number (trial ID): KCT0003245 Type of study: Prospective, Randomized, Multi-Center Study
Background Endoscopic clip placement is technically challenging using a duodenoscope, limiting their application for treatment of bleeding after endoscopic papillectomy. This study evaluated the efficacy of newly designed clips to prevent bleeding after endoscopic papillectomy.
Methods Patients (n = 80) with suspected benign adenomas on the major papilla who were scheduled for endoscopic papillectomy with or without clipping were randomized. A new duodenoscope-compatible clip capable of being rotated, reopened, and repeatedly repositioned was used. The primary end point was incidence of delayed bleeding.
Results The clipping procedure was successful in all patients. The incidence of delayed bleeding was nonsignificantly higher in the no-clipping group than in the clipping group (31.6 % [95 % confidence interval (CI) 19.1–47.5] vs. 15.0 % [95 %CI 7.1–29.1]). The incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis did not differ significantly between the groups (clipping vs. no-clipping: 17.5 % [95 %CI 8.7–31.9] vs. 5.3 % [95 %CI 1.5–17.3]), and all cases were mild.
Conclusions Placement of the newly designed rotatable clip was technically feasible and tended to have a protective effect by preventing delayed bleeding after endoscopic papillectomy, although statistical significance was not reached.
Received: 29 May 2021
Accepted: 02 December 2021
Article published online:
11 February 2022
© 2022. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
- 1 Catalano MF, Linder JD, Chak A. et al. Endoscopic management of adenoma of the major duodenal papilla. Gastrointest Endosc 2004; 59: 225-232
- 2 Irani S, Arai A, Ayub K. et al. Papillectomy for ampullary neoplasm: results of a single referral center over a 10-year period. Gastrointest Endosc 2009; 70: 923-932
- 3 Nam K, Song TJ, Kim RE. et al. Usefulness of argon plasma coagulation ablation subsequent to endoscopic snare papillectomy for ampullary adenoma. Dig Endosc 2018; 30: 485-492
- 4 Baron TH, Norton ID, Herman L. Endoscopic hemoclip placement for post-sphincterotomy bleeding. Gastrointest Endosc 2000; 52: 662
- 5 Daram SR, Tang SJ, Wu R. et al. Benchtop testing and comparisons among three types of through-the-scope endoscopic clipping devices. Surg Endosc 2013; 27: 1521-1529
- 6 Park CH, Park SW, Hyun B. et al. Efficacy and safety of etomidate-based sedation compared with propofol-based sedation during ERCP in low-risk patients: a double-blind, randomized, noninferiority trial. Gastrointest Endosc 2018; 87: 174-184
- 7 Alexander S, Bourke MJ, Williams SJ. et al. EMR of large, sessile, sporadic nonampullary duodenal adenomas: technical aspects and long-term outcome (with videos). Gastrointest Endosc 2009; 69: 66-73
- 8 Park CH, Jung JH, Hyun B. et al. Safety and efficacy of early feeding based on clinical assessment at 4 hours after ERCP: a prospective randomized controlled trial. Gastrointest Endosc 2018; 87: 1040-1049 e1041
- 9 Okano N. The study of early complications of endoscopic papillectomy of the tumor with duodenal major papilla. Tando (Journal of Japan Biliary Association) 2007; 21: 623-629
- 10 Hiroyuki M, Kuniyuki T, Ako K. et al. Indication of endoscopic papillectomy for tumors of the papilla of Vater and its problems. Dig Endosc 2003; 15: S33-35
- 11 De Palma GD. Endoscopic papillectomy: indications, techniques, and results. World J Gastroenterol 2014; 20: 1537-1543
- 12 Kagawa K, Kubota K, Kurita Y. et al. Effect of preventive closure of the frenulum after endoscopic papillectomy: a prospective pilot study. J Gastroenterol Hepatol 2020; 35: 374-379
- 13 Mirjalili SA, Stringer MD. The arterial supply of the major duodenal papilla and its relevance to endoscopic sphincterotomy. Endoscopy 2011; 43: 307-311
- 14 Klein A, Qi Z, Bahin FF. et al. Outcomes after endoscopic resection of large laterally spreading lesions of the papilla and conventional ampullary adenomas are equivalent. Endoscopy 2018; 50: 972-983
- 15 Bohnacker S, Seitz U, Nguyen D. et al. Endoscopic resection of benign tumors of the duodenal papilla without and with intraductal growth. Gastrointest Endosc 2005; 62: 551-560
- 16 Heise C, Abou AliE, Hasenclever D. et al. Systematic review with meta-analysis: endoscopic and surgical resection for ampullary lesions. J Clin Med 2020; 9: 3622
- 17 Han J, Lee DW, Kim HG. Recent advances in endoscopic papillectomy for ampulla of vater tumors: endoscopic ultrasonography, intraductal ultrasonography, and pancreatic stent placement. Clin Endosc 2015; 48: 24-30
- 18 Desilets DJ, Dy RM, Ku PM. et al. Endoscopic management of tumors of the major duodenal papilla: refined techniques to improve outcome and avoid complications. Gastrointest Endosc 2001; 54: 202-208
- 19 Harewood GC, Pochron NL, Gostout CJ. Prospective, randomized, controlled trial of prophylactic pancreatic stent placement for endoscopic snare excision of the duodenal ampulla. Gastrointest Endosc 2005; 62: 367-370