BDD With UDCA Therapy After Laparoscopic Cholecystectomy

Phase 3

• Conditions: Cholecystitis, Chronic; Cholecystitis, Acute
• Interventions: Drug: BDD with UDCA; Drug: Placebo

• Registration Number: NCT03578055
• Lead Sponsor: Ewha Womans University Mokdong Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-04-24
• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-06-25
• Status Verified: 2018-07
• Study First Posted: 2018-07-05
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BDD with UDCA	BDD with UDCA	Postoperative BDD with UDCA treatment
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Serum Aspartate Aminotransferase	Postoperative 30 days	Serum aspartate aminotransferase level (U/ml) (continuous variable)
Serum Alanine Aminotransferase	Postoperative 30 days	Serum Alanine Aminotransferase level (U/ml) (continuous variable)

Secondary Outcome Measures

Name	Time	Method
GIQLI (Gastrointestinal Quality of Life Index)	Postoperative 30 days	Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180)

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of