Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis

Cholelithiasis Clinical Trial

— CREST Choles  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02554097
• Other study ID #: CR-CREST Choles
• Status: Active, not recruiting
• Start date: August 2015
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2018
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2700
• Est. completion date: December 30, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystolithiasis
• Choledocholithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• endoscopic sphincterotomy
Sphincterotomy (EST) is performed to remove the common bile duct stone.
• 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.
• 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.
• laparoscopic cholecystectomy
Laparoscopic cholecystectomy is performed to remove the gallbladder.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (12)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Tongren Hospital, China-Japan Friendship Hospital, LanZhou University, Luhe Hospital, Capital Medical University, Peking Union Medical College Hospital, Peking University, Peking University First Hospital, Peking University Third Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Dalian Medical University, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

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