Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
1 other identifier
observational
200
1 country
1
Brief Summary
In patients with gallbladder in situ after complete removal of common bile duct (CBD) stones, there is no definite guideline for the management of remnant acalculous gallbladder. This study was planned to evaluate the efficacy of choleretic agents in those patients comparing with non-treatment group during short (2 years) and long-term (5 to 10 years) period. So that, the investigators want to establish the treatment guideline in gallbladder in situ without definite stones following complete removal of CBD stones. Second, the protective or preventive effect of choleretics may be defined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Longer than P75 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
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 4, 2013
CompletedFirst Posted
Study publicly available on registry
April 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedApril 11, 2013
April 1, 2013
1.9 years
April 4, 2013
April 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complications
The primary outcome is biliary complications between two groups during follow-up.
two year
Secondary Outcomes (2)
Natural outcomes
two year
Other adverse events
two year
Other Outcomes (1)
Drug-related adverse event
three months
Study Arms (2)
Wait-and-see group
After endoscopic clearance of their bile duct stones, this group of patients will be follow up without additional managements
Choleretics group
After endoscopic clearance of their bile duct stones, this group of patients receives choleretic agents during 3 months
Eligibility Criteria
We randomized patients (\>18 years of age) who underwent therapeutic endoscopic biliary sphincterotomy and/or balloon dilation for the complete clearance of their bile duct stones.
You may qualify if:
- Complete clearance of CBD stones
- No definite GB stones
- Agree with the study protocol
You may not qualify if:
- \< 18 years of age
- Concomitant IHD stones
- Combined malignancy with a limted life span
- Prior cholecystectomy state
- refusal to agree to the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Soon Chun Hyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, 330-721, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 4, 2013
First Posted
April 11, 2013
Study Start
March 1, 2012
Primary Completion
February 1, 2014
Study Completion
December 1, 2021
Last Updated
April 11, 2013
Record last verified: 2013-04