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

April 8, 2013 updated by: Tae Hoon Lee, Soon Chun Hyang University

A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, Korea, Republic of, 330-721
        • Recruiting
        • Soon Chun Hyang University Cheonan Hospital
        • Contact:
          • Tae Hoon Lee, MD, PhD
        • Principal Investigator:
          • Tae Hoon Lee, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: two year
The primary outcome is biliary complications between two groups during follow-up.
two year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Natural outcomes
Time Frame: two year
Other outcome measures included adverse events after choleretics and natural clinical courses of gallbladder in situ.
two year
Other adverse events
Time Frame: two year
Other outcome measures included adverse events after choleretics and natural outcomes of gallbladder in situ.
two year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug-related adverse event
Time Frame: three months
Other outcome measure includes adverse events after choleretics.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soon Chun Hyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 8, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCH-MULTI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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