Comparison of LCBDE vs ERCP + LC for Choledocholithiasis

NACompletedINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

September 1, 2015

Primary Completion Date

January 1, 2024

Study Completion Date

January 1, 2024

Conditions
Choledocholithiasis
Interventions
PROCEDURE

Laparoscopy

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.

PROCEDURE

Endoscopy

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.

Trial Locations (12)

130021

The First Hospital of Jilin University, Changchun

200092

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

250000

Shandong jiaotong Hospital, Jinan

300100

Tianjin Nankai Hospital, Tianjin

310003

The First Affiliated Hospital, Zhejiang University, Hangzhou

400038

Southwest Hospital of Third Military Medical University, Chongqing

410011

Second Xiangya Hospital, Central South University, Changsha

430022

Union hospital,Tongji medical collage,Huazhong University of science and technology, Wuhan

710061

The first affiliated hospital of Xi 'an jiaotong university, Xi’an

730000

The first hospital of Lanzhou University, Lanzhou

750004

General Hospital of Ningxia Medical University, Yinchuan

830054

The First Teaching Hospital of Xinjiang Medical University, Ürümqi

All Listed Sponsors
lead

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

NCT02515474 - Comparison of LCBDE vs ERCP + LC for Choledocholithiasis | Biotech Hunter | Biotech Hunter