Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis (CREST Choles)

Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements - A Multicenter, Prospective and Retrospective Cohort Study Based on Case Register System

Patients with gallstone and confirmed common bile duct stones are registered in this study. The three managements for common bile duct stones are endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative investigations, operative method, operative time, conversion to open procedure, intraoperative and postoperative complications, and the presence of retained and recurrent stones. All patients were followed up for 3 years by telephone interview ang outpatient visits. Abdominal US and liver function tests were carried out whenever any abdominal symptom appeared during the follow-up period. If there were unusual findings, magnetic resonance cholangiopancreatography(MRCP) was carried out.

Study Overview

• Status: Unknown
• Conditions: Gallstones; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis
• Intervention / Treatment: Procedure: endoscopic sphincterotomy; Procedure: laparoscopic cholecystectomy; Procedure: laparoscopic common bile duct exploration; Procedure: laparoscopic transcystic common bile duct exploration

• Study Type: Observational
• Enrollment (Anticipated): 2700

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients are diagnosed with gallstones and common bile duct stones.

Description

Inclusion Criteria:

• Patients with age between 18 - 80 years.
• Patients diagnosed with gallstones.
• Patients diagnosed with common bile duct stone by one of the three exam (MRI、MRCP and CT).
• Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
• Patients accepted one of the three managements (EST+LC, LCBDE and LTCBDE).

Exclusion Criteria:

• Combined with Mirizzi syndrome and intrahepatic bile duct stones
• Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)
• History of upper abdominal surgery.
• Serious heart,brain,lung, metabolic diseases history.
• Pregnant women
• Unwillingness or inability to consent for the study.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EST+LC group; Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy.	Procedure: endoscopic sphincterotomy; Sphincterotomy (EST) is performed to remove the common bile duct stone.; Procedure: laparoscopic cholecystectomy; Laparoscopic cholecystectomy is performed to remove the gallbladder.
LCBDE+LC group; Patients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy.	Procedure: laparoscopic cholecystectomy; Laparoscopic cholecystectomy is performed to remove the gallbladder.; Procedure: laparoscopic common bile duct exploration; Transductal exploration was carried out to remove the common bile duct stone. Primary closure or a T tube drainage was performed according to the results of transductal surgery.
LTCBDE+LC group; Patients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy.	Procedure: laparoscopic cholecystectomy; Laparoscopic cholecystectomy is performed to remove the gallbladder.; Procedure: laparoscopic transcystic common bile duct exploration; A wide local dissection of Calot's triangle is performed and a 2.8mm, 3-mm or 5-mm flexible choledochoscope according to the diameter of the cystic duct is inserted through the cystic duct into the common bile duct. After the common bile duct stone is removed, the cystic duct was ligated with Hem-o-lok.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Adverse outcomes	The patients with complication / the total patients	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental cost-effectiveness ratio	the average incremental cost associated with 1 additional unit of the measure of effect	3 years
Hospital stay	The total days in hospital	3 years
Acute cholangitis rate	The patients with acute cholangitis / the total patients	30 days
Bile leakage rate	The patients with bile juice found in the abdominal cavity after procedures / the total patients	30 days
Stricture of the bile duct rate rate	The patients with any stricture appeared after the procedures / the total patients	3 years
Mortality	Number of death connected with the procedures and complications / total patients	3 years
Perforation Rate	The patients with perforation after the procedures / the total patients	30 days
Hemorrhage Rate	The patients with hemorrhage after the procedures / the total patients	3 years
Operation time	The total time of all the procedures (min)	3 years
Acute pancreatitis Rate	The patients with acute pancreatitis after the procedures / the total patients	30 days

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Peking University; Peking University First Hospital; LanZhou University; Peking Union Medical College Hospital; Shanghai Zhongshan Hospital; Peking University Third Hospital; Xuanwu Hospital, Beijing; Beijing Tongren Hospital; China-Japan Friendship Hospital; The First Affiliated Hospital of Dalian Medical University; Beijing Luhe Hospital, Capital Medical University
• Investigators: Study Chair: Zhongtao Zhang, Doctor, Beijing Friendship Hospital

Publications and helpful links

General Publications

• Zhu JG, Wu S, Feng Q, Li F, Han W, Xiu D, Tan H, Fu J, Li X, Shang D, Liu H, Li B, Yang L, Kong Y, Zhan S, Guo W, Zhang ZT. Protocol for the CREST Choles (Chinese REgistry Study on Treatment of Cholecysto-Choledocholithiasis) study: an ambispective, multicenter, observational, open-cohort study. BMJ Open. 2019 Nov 24;9(11):e030293. doi: 10.1136/bmjopen-2019-030293.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): December 15, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 22, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: laparoscopic common bile duct exploration; cost-effective analysis; laparoscopic transcystic common bile duct exploration; endoscopic sphincterotomy,
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis
• Other Study ID Numbers: CR-CREST Choles