BDD With UDCA Therapy After Laparoscopic Cholecystectomy (BULQ-LC)
Primary Purpose
Cholecystitis, Acute, Cholecystitis, Chronic
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BDD with UDCA
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis, Acute
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
Sites / Locations
- Ewha Womans University Mokdong HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
BDD with UDCA
Placebo
Arm Description
Postoperative BDD with UDCA treatment
Placebo
Outcomes
Primary Outcome Measures
Serum Aspartate Aminotransferase
Serum aspartate aminotransferase level (U/ml) (continuous variable)
Serum Alanine Aminotransferase
Serum Alanine Aminotransferase level (U/ml) (continuous variable)
Secondary Outcome Measures
GIQLI (Gastrointestinal Quality of Life Index)
Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180)
Full Information
NCT ID
NCT03578055
First Posted
June 25, 2018
Last Updated
July 16, 2018
Sponsor
Ewha Womans University Mokdong Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03578055
Brief Title
BDD With UDCA Therapy After Laparoscopic Cholecystectomy
Acronym
BULQ-LC
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University Mokdong Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Acute, Cholecystitis, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BDD with UDCA
Arm Type
Active Comparator
Arm Description
Postoperative BDD with UDCA treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
BDD with UDCA
Other Intervention Name(s)
UDEX
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
No UDEX
Intervention Description
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
Primary Outcome Measure Information:
Title
Serum Aspartate Aminotransferase
Description
Serum aspartate aminotransferase level (U/ml) (continuous variable)
Time Frame
Postoperative 30 days
Title
Serum Alanine Aminotransferase
Description
Serum Alanine Aminotransferase level (U/ml) (continuous variable)
Time Frame
Postoperative 30 days
Secondary Outcome Measure Information:
Title
GIQLI (Gastrointestinal Quality of Life Index)
Description
Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180)
Time Frame
Postoperative 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huisong Lee, M.D., Ph.D.
Phone
+82-2-2650-5694
Email
huisong.lee@ewha.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huisong Lee, M.D., Ph.D.
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huisong Lee, M.D., Ph.D.
Phone
+82-2-2650-5694
Email
huisong.lee@ewha.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BDD With UDCA Therapy After Laparoscopic Cholecystectomy
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