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BDD With UDCA Therapy After Laparoscopic Cholecystectomy (BULQ-LC)

Ewha Womans University logo

Ewha Womans University

Status and phase

Unknown
Phase 3

Conditions

Cholecystitis, Acute
Cholecystitis, Chronic

Treatments

Drug: Placebo
Drug: BDD with UDCA

Study type

Interventional

Funder types

Other

Identifiers

NCT03578055
BULQ-LC trial

Details and patient eligibility

About

Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy

Primary endpoint: peak level of postoperative AST (aspartate transaminase) and postoperative ALT (alanine tansaminase)

Secondary endpoint: postoperative GIQLI (Gastrointestinal Quality of Life index) score

Full description

Because the gallbladder is adjacent to the liver, liver enzymes are often elevated when cholecystitis occurs. BDD and UDCA drugs are known to be effective in preserving liver function. The use of BDD and UDCA drugs in patients with cholecystitis is expected to inhibit elevated liver enzyme levels and to maintain liver function. The aim of this study is to analyze the effects of BDD and UDCA medication on postoperative changes in hepatic enzyme levels and quality of life in patients LFT elevated cholecystitis.

Enrollment

172 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients scheduled for surgery due to chronic cholecystitis and acute cholecystitis

Exclusion criteria

  • Failure to obtain consent
  • Under 19 years
  • If you have intellectual ability to understand this study
  • When performing cholecystectomy with other operations
  • Total bilirubin levels> 2 mg / dl
  • If you are enrolled in another clinical trial

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

172 participants in 2 patient groups, including a placebo group

BDD with UDCA
Active Comparator group
Description:
Postoperative BDD with UDCA treatment
Treatment:
Drug: BDD with UDCA
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Huisong Lee, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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