A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
Sponsor study identifier
observational
200
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 4, 2013
Actual (reported)April 11, 2013
Actual (reported)February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Complications
The primary outcome is biliary complications between two groups during follow-up.
two year
Natural outcomes
two year
Other adverse events
two year
After endoscopic clearance of their bile duct stones, this group of patients will be follow up without additional managements
After endoscopic clearance of their bile duct stones, this group of patients receives choleretic agents during 3 months
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.
Soon Chun Hyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, 330-721, South Korea
First Submitted
April 4, 2013
First Posted
April 11, 2013
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Randomized Trial for Extraction of Difficult Bile Duct Stones
Drug-related adverse event
three months
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 11, 2013
Record last verified: 2013-04
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