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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02554097
Other study ID # CR-CREST Choles
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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