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
ARTICLE HIGHLIGHTS
Research background

Endoscopic papillary large balloon dilation is increasingly being used in treating difficult bile duct stones, since it is faster and less laborious than performing multiple mechanical lithotripsies, with comparable results in terms of safety and effectiveness. However, this method is not recommended in patients with nondilated distal bile ducts, due to a theoretically higher complication rate, especially perforation.

Research motivation

Papillary large balloon dilation is an important tool to extract difficult duct stones and very few studies examined this technique in patients with nondilated distal ducts, although in its original report, this method was used in this setting.

Research objectives

To analyze the feasibility of papillary large balloon dilation in patients with difficult bile duct stones and nondilated distal bile ducts, as well as the complication rate and effectiveness of this method in this subset of stone patients. To investigate the demographic characteristics of this patient group. Data on these issues may stimulate future research and assist endoscopists in choosing the best endoscopic modality to treat difficult bile duct stones.

Research methods

We retrieved data from 1289endoscopic retrograde cholangiopancreatography (ERCP) procedures from 2 prospective randomized controlled trials dealing with post-ERCP pancreatitis (PEP). Of these, 258 cases had difficult stones (> 1 cm, multiple > 8, impacted, or having a thin distal duct) and 191 underwent papillary large balloon dilation up to 15 mm after endoscopic sphincterotomy for stone retrieval. Cholangiographies of these cases were retrospectively reviewed by the authors in order to classify the distal bile duct as dilated or nondilated, as well as stone size and number. Primary outcomes were clearance rate at first ERCP and complications.

Research results

Of the 191 patients, 113 (59%) had a nondilated or tapered distal duct (75 F/38 M, mean age: 52 years) and 78 (47 F/31 M mean age: 68 years) a dilated distal duct. Cases with a nondilated distal duct had fewer (mean = 2 vs 4.1, P < 0.05) and smaller (mean 1.1 cm vs 1.7 cm, P < 0.05) stones than those with a dilated distal duct and were significantly younger than patients with dilated distal). Patients with a nondilated distal duct were also significantly younger and more likely to receive mechanical lithotripsy (25% vs 6.4%, 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, P < 0.005). Complications were similar in both groups: 8/113 (7.1%) vs 5/78 (6.4%), however the 2 perforations occurred in patients with nondilated ducts. There was no mortality.

Research conclusions

Large balloon dilation for difficult stones is feasible in patients with a nondilated or even tapered distal duct. Although the latter patients had smaller stones, they are more difficult to remove, since ERCP procedures in these patients require mechanical lithotripsy more often and last longer.

Research perspectives

Future prospective multicenter studies should evaluate the feasibility of large balloon dilation in patients with nondilated distal bile ducts and difficult stones, since current guidelines do not recommend the procedure in this group of patients.