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

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ClinicalTrials.gov Identifier: NCT03578055
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Huisong Lee, 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


Condition or disease Intervention/treatment Phase
Cholecystitis, Acute Cholecystitis, Chronic Drug: BDD with UDCA Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: UDEX

Placebo Comparator: Placebo
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 Name: No UDEX




Primary Outcome Measures :
  1. Serum Aspartate Aminotransferase [ Time Frame: Postoperative 30 days ]
    Serum aspartate aminotransferase level (U/ml) (continuous variable)

  2. Serum Alanine Aminotransferase [ Time Frame: Postoperative 30 days ]
    Serum Alanine Aminotransferase level (U/ml) (continuous variable)


Secondary Outcome Measures :
  1. GIQLI (Gastrointestinal Quality of Life Index) [ Time Frame: Postoperative 30 days ]
    Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578055


Contacts
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Contact: Huisong Lee, M.D., Ph.D. +82-2-2650-5694 huisong.lee@ewha.ac.kr

Locations
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Korea, Republic of
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 07985
Contact: Huisong Lee, M.D., Ph.D.    +82-2-2650-5694    huisong.lee@ewha.ac.kr   
Sponsors and Collaborators
Ewha Womans University Mokdong Hospital
Investigators
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Principal Investigator: Huisong Lee, M.D., Ph.D. Ewha Womans University Mokdong Hospital

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Responsible Party: Huisong Lee, Assistant Professor, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier: NCT03578055     History of Changes
Other Study ID Numbers: BULQ-LC trial
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
7,7'-dimethoxy-(4,4'-bi-1,3-benzodioxole)-5,5'-dicarboxylic acid dimethyl ester
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 Enzyme Inhibitors