Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis
CREST Choles
Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements - A Multicenter, Prospective and Retrospective Cohort Study Based on Case Register System
1 other identifier
observational
2,700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedNovember 27, 2018
November 1, 2018
3.4 years
September 15, 2015
November 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Adverse outcomes
The patients with complication / the total patients
3 years
Secondary Outcomes (10)
Incremental cost-effectiveness ratio
3 years
Hospital stay
3 years
Acute cholangitis rate
30 days
Bile leakage rate
30 days
Stricture of the bile duct rate rate
3 years
- +5 more secondary outcomes
Study Arms (3)
EST+LC group
Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy.
LCBDE+LC group
Patients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy.
LTCBDE+LC group
Patients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy.
Interventions
Sphincterotomy (EST) is performed to remove the common bile duct stone.
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.
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 is performed to remove the gallbladder.
Eligibility Criteria
Patients are diagnosed with gallstones and common bile duct stones.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Friendship Hospitallead
- Peking University First Hospitalcollaborator
- Xuanwu Hospital, Beijingcollaborator
- Capital Medical Universitycollaborator
- Peking University Third Hospitalcollaborator
- China-Japan Friendship Hospitalcollaborator
- Beijing Tongren Hospitalcollaborator
- LanZhou Universitycollaborator
- The First Affiliated Hospital of Dalian Medical Universitycollaborator
- Shanghai Zhongshan Hospitalcollaborator
- Peking Universitycollaborator
- Peking Union Medical College Hospitalcollaborator
Study Sites (1)
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Related Publications (1)
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.
PMID: 31767583DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhongtao Zhang, Doctor
Beijing Friendship Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
September 15, 2015
First Posted
September 18, 2015
Study Start
August 1, 2015
Primary Completion
December 15, 2018
Study Completion
December 30, 2018
Last Updated
November 27, 2018
Record last verified: 2018-11