BDD With UDCA Therapy After Laparoscopic Cholecystectomy

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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