Clinical trial NCT02554097: Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis
Official title: Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements - A Multicenter, Prospective and Retrospective Cohort Study Based on Case Register System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gallstones
Cholelithiasis
Cholecystolithiasis
Choledocholithiasis
Keywords: laparoscopic transcystic common bile duct exploration
laparoscopic common bile duct exploration
endoscopic sphincterotomy,
cost-effective analysis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Xuanwu Hospital, Beijing
name: Capital Medical University
name: Peking University Third Hospital
name: China-Japan Friendship Hospital
name: Beijing Tongren Hospital
name: LanZhou University
name: The First Affiliated Hospital of Dalian Medical University
name: Shanghai Zhongshan Hospital
name: Peking University
name: Peking Union Medical College Hospital
First posted: 2015-09-18
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are diagnosed with gallstones and common bile duct stones.

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.


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.

Primary outcomes:
measure: Rate of Adverse outcomes
timeFrame: 3 years
Secondary outcomes:
measure: Incremental cost-effectiveness ratio
timeFrame: 3 years
measure: Hospital stay
timeFrame: 3 years
measure: Acute cholangitis rate
timeFrame: 30 days
measure: Bile leakage rate
timeFrame: 30 days
measure: Stricture of the bile duct rate rate
timeFrame: 3 years
measure: Mortality
timeFrame: 3 years
measure: Perforation Rate
timeFrame: 30 days
measure: Hemorrhage Rate
timeFrame: 3 years
measure: Operation time
timeFrame: 3 years
measure: Acute pancreatitis Rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhongtao Zhang, Doctor
role: STUDY_CHAIR
References:
citation: 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.