Brief Title
BDD With UDCA Therapy After Laparoscopic Cholecystectomy
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
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Serum Aspartate Aminotransferase
Secondary Outcome
GIQLI (Gastrointestinal Quality of Life Index)
Condition
Cholecystitis, Acute
Intervention
BDD with UDCA
Study Arms / Comparison Groups
BDD with UDCA
Description: Postoperative BDD with UDCA treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
172
Start Date
April 24, 2018
Completion Date
December 31, 2019
Primary Completion Date
November 30, 2019
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Huisong Lee, M.D., Ph.D., +82-2-2650-5694, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03578055
Organization ID
BULQ-LC trial
Responsible Party
Principal Investigator
Study Sponsor
Ewha Womans University Mokdong Hospital
Study Sponsor
Huisong Lee, M.D., Ph.D., Principal Investigator, Ewha Womans University Mokdong Hospital
Verification Date
July 2018