Endoscopy 2022; 54(08): 787-794
DOI: 10.1055/a-1737-3843
Innovations and brief communications

Effect of prophylactic endoscopic clipping for prevention of delayed bleeding after endoscopic papillectomy for ampullary neoplasm: a multicenter randomized trial

1   Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong-si, Korea
,
Tae Jun Song
2   Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
,
Jin Seok Park
3   Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Korea
,
Jae Hyuk Jun
4   Department of Gastroenterology, Eulji University College of Medicine, Daejeon, Korea
,
Tae Young Park
5   Department of Internal Medicine, Inje University Seoul Paik Hospital, Seoul, Korea
,
Dong Wook Oh
2   Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
,
Sang Soo Lee
2   Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
,
Myung-Hwan Kim
2   Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
› Author Affiliations
Trial 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


Abstract

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.

Table 1 s



Publication History

Received: 29 May 2021

Accepted: 02 December 2021

Article published online:
11 February 2022

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