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

July 16, 2018 updated by: Huisong Lee, Ewha Womans University Mokdong Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Dosage: 1 capsule of placebo, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery
Other Names:
  • No UDEX
Active Comparator: BDD with UDCA
Postoperative BDD with UDCA treatment
Drug: BDD with UDCA
Dosage: Udex 1 capsule, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery
Other Names:
  • UDEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Aspartate Aminotransferase
Time Frame: Postoperative 30 days
Serum aspartate aminotransferase level (U/ml) (continuous variable)
Postoperative 30 days
Serum Alanine Aminotransferase
Time Frame: Postoperative 30 days
Serum Alanine Aminotransferase level (U/ml) (continuous variable)
Postoperative 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GIQLI (Gastrointestinal Quality of Life Index)
Time Frame: Postoperative 30 days
Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180)
Postoperative 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University Mokdong Hospital

Investigators

  • Principal Investigator: Huisong Lee, M.D., Ph.D., EWHA Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

June 25, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BULQ-LC trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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