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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01829139

Enrollment

200

Registered

2013-04-11

Start date

2012-03-31

Completion date

2021-12-31

Last updated

2013-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Complications, Choleretics, Common Bile Duct Stones, Gallbladder in Situ

Keywords

Common bile duct stone, Gallbladder in situ, Choleretics

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Other

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

Countries

South Korea

Contacts

Primary ContactTae Hoon Lee, MD, PhD

thlee9@schmc.ac.kr+82-41-570-3662

Outcome results