Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis

NCT ID: NCT02554097

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-12-30

Brief Summary

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.

Conditions

Gallstones; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

EST+LC group

Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy.

endoscopic sphincterotomy

Intervention Type: PROCEDURE

Sphincterotomy (EST) is performed to remove the common bile duct stone.

laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Laparoscopic cholecystectomy is performed to remove the gallbladder.

LCBDE+LC group

Patients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy.

laparoscopic common bile duct exploration

Intervention Type: PROCEDURE

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.

laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Laparoscopic cholecystectomy is performed to remove the gallbladder.

LTCBDE+LC group

Patients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy.

laparoscopic transcystic common bile duct exploration

Intervention Type: PROCEDURE

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.

laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Laparoscopic cholecystectomy is performed to remove the gallbladder.

Interventions

endoscopic sphincterotomy

Sphincterotomy (EST) is performed to remove the common bile duct stone.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

laparoscopic cholecystectomy

Laparoscopic cholecystectomy is performed to remove the gallbladder.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Capital Medical University

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role: collaborator

LanZhou University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhongtao Zhang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhongtao Zhang, Doctor

Role: STUDY_CHAIR

Beijing Friendship Hospital

Locations

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31767583 (View on PubMed)

Other Identifiers

CR-CREST Choles

Identifier Type: -

Identifier Source: org_study_id