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CC BY-NC-ND 4.0 · Endosc Int Open 2024; 12(11): E1392-E1400
DOI: 10.1055/a-2443-1514
Original article

Enteroscopy-assisted ERCP in patients with surgically altered anatomy: Multicenter prospective registry (SAMISEN-B) using motorized spiral enteroscopy

Tom G Moreels 
1   Hepato-Gastroenterology, Cliniques Universitaires de Saint Luc, Brussels, Belgium
,
Lars Aabakken
2   Gastroenterology, Oslo University Hospital, Oslo, Norway (Ringgold ID: RIN155272)
3   Institute of Clinical Medicine, University of Oslo, Oslo, Norway (Ringgold ID: RIN6305)
,
Marianna Arvanitakis
4   Gastroenterology, Hepatopancreatology and Digestive Oncology, Université libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (H.U.B), CUB Hôpital Erasme, Brussels, Belgium
,
Mate Knabe 
5   Department of Internal Medicine A, Goethe University Frankfurt Frankfurt University Hospital, Frankfurt am Main, Germany (Ringgold ID: RIN14984)
6   Gastroenterology, Bethanien-Hospital, Frankfurt am Main, Germany (Ringgold ID: RIN62556)
,
Torsten Beyna
7   Department of Internal Medicine, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany
› Author Affiliations
Supported by: Olympus Europa SE & CO. KG. Project ID 2021-0945 Clinical Trial: Registration number (trial ID): NCT05129449, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: prospective multicenter study
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Correction: Enteroscopy-assisted ERCP in patients with surgically altered anatomy: Multicenter prospective registry (SAMISEN-B) using motorized spiral enteroscopyEndosc Int Open 2024; 12(11): C10-C10
DOI: 10.1055/a-2494-3747

Abstract

Background and study aims This was a prospective study of efficacy and safety of motorized spiral enteroscopy (MSE) to perform biliary endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy at five European centers.

Patients and methods Consecutive patients with biliary indications for enteroscopy-assisted ERCP were enrolled. Objectives were technical success, adverse event (AE) rate, and patient radiation exposure.

Results Eighty-nine patients were enrolled and one was excluded for a pancreatic indication. All participants had variations of Billroth II reconstruction (29.5%) or Roux-en-Y reconstruction (70.5%), either with naive papilla (39%) or hepaticojejunostomy (61%). Main indications were anastomotic stricture treatment and/or biliary stone removal. Enteroscopy to reach the bile duct was possible in 65 of 88 patients (74%), bile duct cannulation in 54 of 88 (61%), and therapeutic ERCP was technically successful in 48 of 88 (54%). In Billroth II variations, technical success was achieved in 13 of 26 patients (50%) compared with 35 of 62 (57%, P = 0.5792 Chi square) in Roux-en-Y reconstructions (including bariatric gastric bypass). ERCP with intact papilla was successful in 17 of 34 patients (50%) compared with 31 of 54 (57%, P = 0.4968 Chi square) in hepaticojejunostomy. The study was prematurely terminated July 2023 because MSE was withdrawn by the manufacturer for safety issues. Overall, in 12 of 88 patients (14%), AEs were recorded and six (7%) were considered serious. Only one serious AE was attributable to MSE enteroscopy: perforation of the proximal esophagus during enteroscope insertion.

Conclusions This prospective multicenter study was prematurely discontinued due to withdrawal of the MSE by the manufacturer because of safety issues. Technical success of MSE-assisted biliary ERCP in different types of surgically altered anatomy was 54%, which was lower than anticipated. There was one esophageal perforation attributable to use of MSE. (clinicaltrials.gov: NCT05129449)

Keywords

Endoscopy Small Bowel - Small bowel endoscopy - Pancreatobiliary (ERCP/PTCD) - GI surgery


Publication History

Received: 10 June 2024

Accepted after revision: 16 October 2024

Accepted Manuscript online:
17 October 2024

Article published online:
28 November 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

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