BDD With UDCA Therapy After Laparoscopic Cholecystectomy | NCT03578055

Studies
BDD With UDCA Therapy After Laparoscopic Cholecystectomy

NCT03578055

Sponsor

Ewha Womans University Mokdong Hospital

Status

Unknown status

Last Update Posted

Jul 18, 2018Actual

Enrollment

172Estimated

Phase

Phase 3

Conditions

Cholecystitis, Acute
Cholecystitis, Chronic

Interventions

BDD with UDCA
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2018Actual

Primary Completion Date

Nov 30, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Jun 25, 2018

First Submission Date that Met QC Criteria

Jun 25, 2018

First Posted Date

Jul 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2018

Last Update Posted Date

Jul 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Huisong Lee, Assistant Professor, Ewha Womans University Mokdong HospitalPrincipal Investigator

Lead Sponsor

Ewha Womans University Mokdong HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

172Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BDD with UDCA	Active Comparator	Postoperative BDD with UDCA treatment	Drug: BDD with UDCA
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
GIQLI (Gastrointestinal Quality of Life Index)	Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180)	Postoperative 30 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huisong Lee, M.D., Ph.D.	Contact	+82-2-2650-5694		huisong.lee@ewha.ac.kr

Overall Officials

Name	Affiliation	Role
Huisong Lee, M.D., Ph.D.	Ewha Womans University Mokdong Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ewha Womans University Mokdong Hospital	Recruiting	Seoul		07985	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D041881	Cholecystitis, Acute
D002764	Cholecystitis
D000092122	Bronchiolitis Obliterans Syndrome

Ancestor Terms

ID	Term
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D000092124	Organizing Pneumonia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C041398	7,7'-dimethoxy-(4,4'-bi-1,3-benzodioxole)-5,5'-dicarboxylic acid dimethyl ester
D014580	Ursodeoxycholic Acid

Ancestor Terms

ID	Term
D003840	Deoxycholic Acid
D002793	Cholic Acids
D001647	Bile Acids and Salts
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided