RCT on Necessity of Cholecystectomy for Patients After Clearance of Bile Duct Stones
Randomized Controlled Trial on Necessity of Cholecystectomy for Patients With Bile Duct Stones Combined With Gallbladder Stones After Clearance of Stones
1 other identifier
interventional
128
1 country
1
Brief Summary
To discuss necessity of cholecystectomy for patients with stones in their bile ducts and gallbladders in the absence of absolute operation indications of cholecystectomy after clearance of bile duct stones with ERCP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Shorter than P25 for not_applicable
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
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 5, 2018
CompletedFirst Posted
Study publicly available on registry
July 5, 2018
CompletedJuly 5, 2018
June 1, 2018
3 months
June 5, 2018
June 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
biliary events
The incidence of biliary events will be compared in the two groups.
12 months
Secondary Outcomes (1)
adverse events
12 months
Study Arms (2)
gallbladder preserved
PLACEBO COMPARATORPatients with stones in their bile ducts and gallbladders will keep gallbladders in stay after clearance of bile duct stones with ERCP.
cholecystectomy
EXPERIMENTALPatients with stones in their bile ducts and gallbladders will undergo cholecystectomy after clearance of bile duct stones with ERCP.
Interventions
Gallbladders will be remained after clearance of bile duct stones with ERCP and conventional therapy, such as fluid replacement and prophylactic anti infection, will be accepted.
Cholecystectomy will be done right now after clearance of bile duct stones with ERCP, and then conventional therapy will be accepted.
Eligibility Criteria
You may qualify if:
- Obtention of a written informed consent; Clinical diagnosis of gallbladder stones and common bile duct stones; No absolute operation indications of cholecystectomy
You may not qualify if:
- Intrahepatic stones; Malignant tumor disease ;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 31006, China
Related Publications (1)
Heo J, Jung MK, Cho CM. Should prophylactic cholecystectomy be performed in patients with concomitant gallstones after endoscopic sphincterotomy for bile duct stones? Surg Endosc. 2015 Jun;29(6):1574-9. doi: 10.1007/s00464-014-3844-8. Epub 2014 Oct 8.
PMID: 25294531BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xiangfeng Zhang, M.S
First People's Hospital of Hangzhou
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director
Study Record Dates
First Submitted
June 5, 2018
First Posted
July 5, 2018
Study Start
November 1, 2017
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
July 5, 2018
Record last verified: 2018-06