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

S

Soon Chun Hyang University

Status

Unknown

Conditions

Biliary Complications
Common Bile Duct Stones
Choleretics
Gallbladder in Situ

Study type

Observational

Funder types

Other

Identifiers

NCT01829139
SCH-MULTI

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial design

200 participants in 2 patient groups

Wait-and-see group
Description:
After endoscopic clearance of their bile duct stones, this group of patients will be follow up without additional managements
Choleretics group
Description:
After endoscopic clearance of their bile duct stones, this group of patients receives choleretic agents during 3 months

Trial contacts and locations

1

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Central trial contact

Tae Hoon Lee, MD, PhD

Data sourced from clinicaltrials.gov

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