CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,000 enrolled
Drug / intervention
Laparoscopy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02515474
NCT02515474N/ACompleted

A Long Term Comparison of Laparoscopic Common Bile Duct Exploration and Cholecystectomy Versus Sequential ERCP Followed by Cholecystectomy for Choledocholithiasis: a Multicenter Prospected Non-randomized Controlled Study

Hepatopancreatobiliary Surgery Institute of Gansu Province·interventional·Posted Aug 4, 2015·Updated Jan 5, 2024

In Brief

A clinical study evaluating Laparoscopy and Endoscopy for Choledocholithiasis. Completed, enrolled 1,000 participants across 12 sites.

Detailed Summary

Protection of Oddi's sphincter remains a huge argument especially in the long term complications like common bile duct stone recurrence or cholangitis after ERCP, which determined to destroy the sphincter of Oddi. The purpose of this study is to compare the long-term outcomes of ERCP sequential LC versus LCBDE for choledocholithiasis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 4, 2015
Enrollment StartSep 1, 2015
Primary CompletionJan 1, 2024
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 10.9 years ago

Interventions

Laparoscopyprocedure

After removing the gallbladder, Laparoscopic common bile duct exploration (LCBDE) was performed by one fulltime attending in laparoscopy in a routine fashion. Access from the opening of the anterior wall of common bile duct or from the dilated cystic duct was acceptable, removed stone(s) and irrigated the duct followed by choledochoscope detection simultaneously. Cholangiograms were also can be a alternative method to obtain stone clearance. If needed, all fluoroscopy was performed by the principal author in the presence of and concurrence with the ERCP endoscopist. Once the LCBDE was completed, the incision of the bile duct was sewed intermittently by absorbed threads, or ligated cystic duct. T-tube was acceptable if needed.

Endoscopyprocedure

Initially endoscopic retrograde cholangiopancreatography (ERCP) was performed by a fulltime attending and concurrence of the principal author in endoscopy. Patients randomized to ERCP+ LC group were scheduled to undergo the endoscopic procedure using fluoroscopy in the endoscopy center under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Gastric intestinal atony during ERCP was routinely achieved using scopolamine butylbromide injection. Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be choose accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month.