Randomized Clinical Trial
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Jul 16, 2022; 14(7): 424-433
Published online Jul 16, 2022. doi: 10.4253/wjge.v14.i7.424
Feasibility of endoscopic papillary large balloon dilation to remove difficult stones in patients with nondilated distal bile ducts
Julio Carlos Pereira Lima, Giusepe Saifert Moresco, Ivan David Arciniegas Sanmartin, Isabela Contin, Guilherme Pereira-Lima, Guilherme Watte, Stephan Altmayer, Carlos Eduardo Oliveira dos Santos
Julio Carlos Pereira Lima, Giusepe Saifert Moresco, Ivan David Arciniegas Sanmartin, Isabela Contin, Guilherme Pereira-Lima, Department of Gastroenterology, Endoscopy Division, Federal University of Health Sciences of Porto Alegre/Santa Casa Hospital, Porto Alegre 90020-090, RS, Brazil
Guilherme Watte, Stephan Altmayer, Department of Biostatistics and Epidemiology, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre 90619-900, RS, Brazil
Carlos Eduardo Oliveira dos Santos, Department of Gastroenterology and Endoscopy, Santa Casa Hospital, Bagé 96400-130, RS, Brazil
Author contributions: Pereira Lima JC, Saifert Moresco G, Sanmartin IDA, Contin I, Pereira-Lima G, Watte G, Altmayer S, Oliveira dos Santos CE, have been involved equally and have read and approved the final manuscript; Pereira Lima JC, Saifert Moresco G, Sanmartin IDA, Contin I, Pereira-Lima G, Watte G, Altmayer S, Oliveira dos Santos CE meet the criteria for authorship established by the International Committee of Medical Journal Editors and verify the validity of the results reported.
Institutional review board statement: This study and protocols were approved by the Research Ethics Commission of our Institution and registered in the Brazilian Protocol Registry under number RBR-979wh3 (http://www.ensaiosclinicos.gov.br/rg/RBR-979wh3) and UTN Number: U111-1207-7823 (URL: http://www.ensaiosclinicos.gov.br/rg/RBR-6zkm5k/). Written informed consent was obtained from all patients. The study adheres to the declaration of Helsinki.
Clinical trial registration statement: Brazilian Protocol Registry under number RBR-979wh3 (http://www.ensaiosclinicos.gov.br/rg/RBR-979wh3) and UTN Number: U111-1207-7823 (URL:http://www.ensaiosclinicos.gov.br/rg/RBR-6zkm5k/).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Prof. Dr. Julio Pereira Lima (jpereiralima@terra.com.br) is on the speakers’ board of Takeda Pharmaceutical Latin America and receives honoraria as consultant of Boston Scientific, Latin America and Cook Endoscopy, Brazil. Dr. Carlos Eduardo Oliveira dos Santos (ddendo@uol.com.br) receives speaker fees and is a consultant of the speakers’ board of Fujinon Co., Latin America. Drs. Giusepe Saifert Moresco (giusepemoresco@outlook.com), Ivan David Arciniegas Sanmartín (davidarciniegas23@gmail.com), Isabela Contin (isabeladbcontin@gmail.com), Guilherme Pereira Lima (guilhermepl14@gmail.com), Guilherme Watte (g.watte@gmail.com), and Stephan Altmayerstephanaltmayer@gmail.com) have no conflicts of interest or financial ties to disclose.
Data sharing statement: Dataset available from the corresponding author at pereiralimajulio@gmail.com. Participants gave informed consent for data sharing.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Julio Carlos Pereira Lima, FASGE, MD, MSc, PhD, Professor, Department of Gastroenterology, Endoscopy Division, Federal University of Health Sciences of Porto Alegre/Santa Casa Hospital, Rua Professor Annes Dias, 295, Porto Alegre 90020-090, RS, Brazil. pereiralimajulio@gmail.com
Received: January 21, 2022
Peer-review started: January 21, 2022
First decision: April 19, 2022
Revised: May 10, 2022
Accepted: June 24, 2022
Article in press: June 24, 2022
Published online: July 16, 2022
Processing time: 174 Days and 6.8 Hours
Abstract
BACKGROUND

Current guidelines recommend not performing papillary large balloon dilation in patients with nondilated distal bile ducts.

AIM

To assess the feasibility of balloon dilation to remove difficult stones in patients with nondilated distal bile ducts.

METHODS

Data from 1289 endoscopic retrograde cholangiopancreatography (ERCP) procedures were obtained from two prospective studies. While 258 cases had difficult stones (> 1 cm, multiple > 8, impacted, or having a thin distal duct), 191 underwent biliary dilation up to 15 mm after endoscopic sphincterotomy. Cholangiographies of these cases were retrospectively reviewed in order to classify the distal bile duct and both the stone size and number. Primary outcomes were clearance rate at first ERCP and complications.

RESULTS

Of the 191 patients (122 women and 69 men; mean age: 60 years) who underwent biliary dilation for difficult stones, 113 (59%) had a nondilated or tapered distal duct. Patients with a dilated distal duct were older than those with nondilated distal ducts (mean 68 and 52 years of age, respectively; P < 0.05), had more stones (median 4 and 2 stones per patient, respectively; P < 0.05), and had less need for additional mechanical lithotripsy (6.4% vs 25%, respectively; P < 0.05). Clearance rate at first ERCP was comparable between patients with a dilated (73/78; 94%) and nondilated distal ducts (103/113; 91%). Procedures were faster in patients with a dilated distal duct (mean 17 vs 24 min, respectively; P < 0.005). Complications were similar in both groups (6.4% vs 7.1%, respectively).

CONCLUSION

Large balloon dilation for difficult stones is feasible in patients with a nondilated or even tapered distal duct.

Keywords: Difficult bile duct stones; Endoscopic retrograde cholangiopancreatography; Balloon dilation; Complications; Biliary dilation; Cholangiography

Core Tip: Endoscopic papillary large balloon dilation is increasingly being used in treating difficult bile duct stones, since it is faster and less laborious than mechanical lithotripsy, with comparable results in terms of safety and effectiveness. However, this method is not recommended in patients with nondilated distal ducts, due to a higher complication rate, especially perforation. This study evaluated a large cohort of difficult duct stones patients submitted to large balloon dilation and found that patients with dilated and nondilated distal ducts had similar complication rates. This study suggests that large balloon dilation may be feasible in the latter group of patients.