Systematic Reviews
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Aug 16, 2018; 10(8): 130-144
Published online Aug 16, 2018. doi: 10.4253/wjge.v10.i8.130
Comparison between endoscopic sphincterotomy vs endoscopic sphincterotomy associated with balloon dilation for removal of bile duct stones: A systematic review and meta-analysis based on randomized controlled trials
Cesar Capel de Clemente Junior, Wanderley Marques Bernardo, Tomazo Prince Franzini, Gustavo Oliveira Luz, Marcos Eduardo Lera dos Santos, Jonah Maxwell Cohen, Diogo Turiani Hourneaux de Moura, Fábio Ramalho Tavares Marinho, Martin Coronel, Paulo Sakai, Eduardo Guimarães Hourneaux de Moura
Cesar Capel de Clemente Junior, Wanderley Marques Bernardo, Tomazo Prince Franzini, Gustavo Oliveira Luz, Marcos Eduardo Lera dos Santos, Diogo Turiani Hourneaux de Moura, Fábio Ramalho Tavares Marinho, Martin Coronel, Paulo Sakai, Eduardo Guimarães Hourneaux de Moura, Gastrointestinal Endoscopy Unit, Department of Gastroenterology, University of Sao Paulo Medical School, Sao Paulo 05403-010, Brazil
Jonah Maxwell Cohen, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, United States
Author contributions: de Clemente Junior CC and Franzini TP contributed equally to the work; de Clemente Junior CC conceptualized and designed the review together with Bernardo WM; de Clemente Junior CC, Luz GO, dos Santos MEL, Marinho FRT, Coronel M and de Moura EGH carried out the analysis; de Clemente Junior CC and Sakai P drafted the initial manuscript; de Moura DTH, Cohen JM contributed to the major review changes and language; all authors reviewed and approved the final manuscript as submitted.
Conflict-of-interest statement: The authors declare that there is no conflict of interests regarding the publication of this paper.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Cesar Capel de Clemente Junior, MD, Academic Research, Gastrointestinal Endoscopy Unit, Department of Gastroenterology, University of Sao Paulo Medical School, R. Dr. Ovídio Pires de Campos, 255-Cerqueira César, Sao Paulo 05403-010, Brazil. cesar.capel@hc.fm.usp.br
Telephone: +55-11-26616467
Received: November 20, 2017
Peer-review started: November 21, 2017
First decision: December 12, 2017
Revised: March 2, 2018
Accepted: March 28, 2018
Article in press: March 28, 2018
Published online: August 16, 2018
Processing time: 269 Days and 10.5 Hours
Abstract
AIM

To compare gallstones removal rate and incidence of bleeding, pancreatitis, use of mechanical lithotripsy, cholangitis and perforation between isolated sphincterotomy vs sphincterotomy associated with balloon dilation of papilla in choledocholithiasis through the meta-analysis of randomized clinical trials.

METHODS

We conducted a systematic review according to the PRISMA guidelines. Literature search was restricted to randomized controlled trials (RCTs) on MedLine, Cochrane Library, LILACS, and EMBASE database platforms in July 2017. The manual search included references of retrieved articles. We extracted data focusing on outcomes: The primary endpoint was the stones removal rate; Secondary endpoints were rates of pancreatitis, bleeding, use of mechanical lithotripsy (ML), perforation and cholangitis.

RESULTS

Eleven RCTs with 1824 patients were included. EST was associated with more post-endoscopic retrograde cholangiopancreatography (ERCP) bleeding [FE RD-0.02, CI (-0.03, -0.00), I2 = 33%, P = 0.05] and more need of mechanical lithotripsy in general [RE RD-0.16, CI (-0.25, -0.06), I2 = 90%, P = 0.002] and in subgroup analysis of stones greater than 15 mm [RE RD-0.20, CI (-0.38, -0.02), I2 = 82%, P = 0.003]. Incidence of pancreatitis [FE RD-0.01, CI (-0.03, 0.01), I2 = 0, P = 0.36], cholangitis [FE RD-0.00, CI (-0.01, 0.01), I2 =0, P = 0.97] and perforation [FE RD-0.01, CI (-0.01, 0.00), I2 = 0, P = 0.23] was similar between the groups as well as similar stone removal rates in general [FE RD-0.01, CI (-0.01, 0.04), I2 = 0, P = 0.23] and pooled analysis of stones greater than 15 mm [FE RD-0.02, CI (-0.02, 0.07), I2 = 11%, P = 0.31].

CONCLUSION

Through meta-analysis of randomized clinical trials we found that isolated sphincterotomy was associated with more post-ERCP bleeding and more need for mechanical lithotripsy. However, there was no statistical difference in the stone removal rate between isolated sphincterotomy and sphincterotomy associated with balloon dilation in the approach to remove gallstones.

Keywords: Sphincterotomy; Papillotomy; Dilation; Cholangiopancreatography; Endoscopic retrograde; Endoscopic retrograde cholangiopancreatography; Cholangiography

Core tip: Our initial motivation was to determine if there is a preferential endoscopic approach in choledocholithiasis, comparing efficacy and safety data between the two most widespread endoscopic methods, which is sphincterotomy with vs without large balloon dilation. Through the systematic review, it was possible to perform the meta-analysis of a large sample of patients obtained from properly conducted randomized clinical trials. We found that endoscopic sphincterotomy associated with large balloon dilation was a safer method compared to isolated sphincterotomy, since this last group carried an increased risk of post ERCP bleeding and required more frequent complementation with use of mechanical lithotripsy.