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

NCT ID: NCT01829139

Last Updated: 2013-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Common Bile Duct Stones Gallbladder in Situ Choleretics Biliary Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Wait-and-see group

After endoscopic clearance of their bile duct stones, this group of patients will be follow up without additional managements

No interventions assigned to this group

Choleretics group

After endoscopic clearance of their bile duct stones, this group of patients receives choleretic agents during 3 months

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soon Chun Hyang University

OTHER

Sponsor Role lead

Responsible Party

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Tae Hoon Lee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Soon Chun Hyang University Cheonan Hospital

Cheonan, Chungcheongnam-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Tae Hoon Lee, MD, PhD

Role: CONTACT

+82-41-570-3662

Facility Contacts

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Tae Hoon Lee, MD, PhD

Role: primary

Other Identifiers

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SCH-MULTI

Identifier Type: -

Identifier Source: org_study_id

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