BDD With UDCA Therapy After Laparoscopic Cholecystectomy

NCT03578055 | Unknown Phase 3

• 1 other identifier: BULQ-LC trial
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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

Conditions

Cholecystitis, Acute; Cholecystitis, Chronic

Outcome Measures

Primary Outcomes (2)

• Serum Aspartate Aminotransferase

  Serum aspartate aminotransferase level (U/ml) (continuous variable)

  Postoperative 30 days

• Serum Alanine Aminotransferase

  Serum Alanine Aminotransferase level (U/ml) (continuous variable)

  Postoperative 30 days

Secondary Outcomes (1)

• GIQLI (Gastrointestinal Quality of Life Index)

  Postoperative 30 days

Study Arms (2)

BDD with UDCA

ACTIVE COMPARATOR

Postoperative BDD with UDCA treatment

Drug: BDD with UDCA

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

BDD with UDCA DRUG

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

Also known as: UDEX

BDD with UDCA

Placebo DRUG

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

Also known as: No UDEX

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

RECRUITING

MeSH Terms

Conditions

Cholecystitis, Acute; Cholecystitis; Bronchiolitis Obliterans Syndrome

Interventions

7,7'-dimethoxy-(4,4'-bi-1,3-benzodioxole)-5,5'-dicarboxylic acid dimethyl ester; Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Huisong Lee, M.D., Ph.D.

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huisong Lee, M.D., Ph.D.

CONTACT

+82-2-2650-5694; huisong.lee@ewha.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 5, 2018
• Study Start: April 24, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)