BDD With UDCA Therapy After Laparoscopic Cholecystectomy

Cholecystitis, Acute Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578055
• Other study ID #: BULQ-LC trial
• Status: Recruiting
• Phase: Phase 3
• Start date: April 24, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2018
• Source: Ewha Womans University Mokdong Hospital
• Contact: Huisong Lee, M.D., Ph.D.
• Phone: +82-2-2650-5694
• Email: huisong.lee[@]ewha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute
• Cholecystitis, Chronic

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Aspartate Aminotransferase	Serum aspartate aminotransferase level (U/ml) (continuous variable)	Postoperative 30 days
Primary	Serum Alanine Aminotransferase	Serum Alanine Aminotransferase level (U/ml) (continuous variable)	Postoperative 30 days
Secondary	GIQLI (Gastrointestinal Quality of Life Index)	Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180)	Postoperative 30 days