Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones

• Conditions: Common Bile Duct Stones; Gallbladder in Situ; Choleretics; Biliary Complications

• Registration Number: NCT01829139
• Lead Sponsor: Soon Chun Hyang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2013-04
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-08
• Last Update Submitted: 2013-04-08
• Study First Posted: 2013-04-11
• Last Update Posted: 2013-04-11
• Primary Completion: 2014-02
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Complete clearance of CBD stones
• No definite GB stones
• Agree with the study protocol

Exclusion Criteria

• < 18 years of age
• Concomitant IHD stones
• Combined malignancy with a limted life span
• Prior cholecystectomy state
• refusal to agree to the study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complications	two year	The primary outcome is biliary complications between two groups during follow-up.

Secondary Outcome Measures

Name	Time	Method
Natural outcomes	two year	Other outcome measures included adverse events after choleretics and natural clinical courses of gallbladder in situ.
Other adverse events	two year	Other outcome measures included adverse events after choleretics and natural outcomes of gallbladder in situ.

Trial Locations

Locations (1)

Soon Chun Hyang University Cheonan Hospital; 🇰🇷 Cheonan, Chungcheongnam-do, Korea, Republic of