Clinical Trials Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 21, 2015; 21(7): 2147-2151
Published online Feb 21, 2015. doi: 10.3748/wjg.v21.i7.2147
Is intraoperative cholangiography necessary during laparoscopic cholecystectomy for cholelithiasis?
Guo-Qian Ding, Wang Cai, Ming-Fang Qin
Guo-Qian Ding, Wang Cai, Ming-Fang Qin, Tianjin Nankai Hospital, Tianjin 300100, China
Guo-Qian Ding, Nankai Clinical School of Medicine, Tianjin Medical University, Tianjin 300700, China
Author contributions: Ding GQ, Cai W and Qin MF contributed equally to this work; Ding GQ designed the study, analyzed the data, and wrote the manuscript; Cai W and Qin MF performed the research.
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: Ming-Fang Qin, Professor, Tianjin Nankai Hospital, 122 Sanwei Road, Nankai District, Tianjin 300100, China. dingguoqian@126.com
Telephone: +86-22-27435267 Fax: +86-22-27435268
Received: June 20, 2014
Peer-review started: June 25, 2014
First decision: July 21, 2014
Revised: September 6, 2014
Accepted: October 14, 2014
Article in press: October 15, 2014
Published online: February 21, 2015
Processing time: 235 Days and 17.7 Hours
Abstract

AIM: To determine the efficacy and safety benefits of performing intraoperative cholangiography (IOC) during laparoscopic cholecystectomy (LC) to treat symptomatic cholelithiasis.

METHODS: Patients admitted to the Minimally Invasive Surgery Center of Tianjin Nankai Hospital between January 2012 and January 2014 for management of symptomatic cholelithiasis were recruited for this prospective randomized trial. Study enrollment was offered to patients with clinical presentation of biliary colic symptoms, radiological findings suggestive of gallstones, and normal serum biochemistry results. Study participants were randomized to receive either routine LC treatment or LC + IOC treatment. The routine LC procedure was carried out using the standard four-port technique; the LC + IOC procedure was carried out with the addition of meglumine diatrizoate (1:1 dilution with normal saline) injection via a catheter introduced through a small incision in the cystic duct made by laparoscopic scissors. Operative data and postoperative outcomes, including operative time, retained common bile duct (CBD) stones, CBD injury, other complications and length of hospital stay, were recorded for comparative analysis. Inter-group differences were statistically assessed by the χ2 test (categorical variables) and Fisher’s exact test (binary variables), with the threshold for statistical significance set at P < 0.05.

RESULTS: A total of 371 patients were enrolled in the trial (late-adolescent to adult, age range: 16-70 years), with 185 assigned to the routine LC group and 186 to the LC + IOC group. The two treatment groups were similar in age, sex, body mass index, duration of symptomology, number and size of gallstones, and clinical symptoms. The two treatment groups also showed no significant differences in the rates of successful LC (98.38% vs 97.85%), CBD stone retainment (0.54% vs 0.00%), CBD injury (0.54% vs 0.53%) and other complications (2.16% vs 2.15%), as well as in duration of hospital stay (5.10 ± 1.41 d vs 4.99 ± 1.53 d). However, the LC + IOC treatment group showed significantly longer mean operative time (routine LC group: 43.00 ± 4.15 min vs 52.86 ± 4.47 min, P < 0.01). There were no cases of fatal complications in either group. At the one-year follow-up assessment, one patient in the routine LC group reported experiencing diarrhea for three months after the LC and one patient in the LC + IOC group reported on-going intermittent epigastric discomfort, but radiological examination provided no abnormal findings.

CONCLUSION: IOC addition to the routine LC treatment of symptomatic cholelithiasis does not improve rates of CBD stone retainment or bile duct injury but lengthens operative time.

Keywords: Cholelithiasis; Cholecystectomy; Cholangiography; Laparoscopic; Gallstones

Core tip: The clinical benefits, in terms of efficacy and safety, of performing the additional intraoperative cholangiography (IOC) procedure during laparoscopic cholecystectomy (LC) treatment in patients with symptomatic cholelithiasis are not definitively established. This prospective randomized trial was designed to compare the operative and outcome features of patients treated by routine LC or LC + IOC. No statistically significant benefits were found for rates of common bile duct (CBD) stone retainment, CBD injury or other complications, or length of hospital stay, but the LC + IOC treatment required significantly longer operative time.