Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis

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

Interventions

PROCEDURE

endoscopic sphincterotomy

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

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.

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.

PROCEDURE

laparoscopic cholecystectomy

Laparoscopic cholecystectomy is performed to remove the gallbladder.

Sponsors & Collaborators

• Peking University First Hospital

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Capital Medical University

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• Beijing Tongren Hospital

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Peking University

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Beijing Friendship Hospital

  lead OTHER

Principal Investigators

• Zhongtao Zhang, Doctor · Beijing Friendship Hospital

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2018-12-15

Completion

2018-12-30

Countries

• China

Study Locations