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The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients With Obstructive Jaundice

Primary Purpose

Obstructive Jaundice

Status
Unknown status
Phase
Phase 2
Locations
Serbia
Study Type
Interventional
Intervention
Ursodeoxycholic Acid
Sponsored by
University Clinical Centre of Kosova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Jaundice focused on measuring obstructive jaundice, ursodeoxycholic acid

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Patients with obstructive jaundice
  • Serum bilirubin level higher than 50 micromole/l
  • 19+ years of age
  • written informed consent

Exclusion criteria:

  • Cholangitis
  • Acute pancreatitis
  • pregnant women
  • women during the breastfeeding
  • suspected or proven primary liver diseases
  • My family members
  • Patients who are unable to understand our study purpose

Sites / Locations

  • University clinical centre of Kosovo, Department of general surgery
  • University clinical centre of Kosovo
  • University clinical centre of Kosovo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ursodeoxycholic acid

Arm Description

Ursodeoxycholic acid administration UDCA administration will begin twenty-four hours after endoscopic or surgical procedure and will last fourteen days. UDCA dose will be administered at 750 mg/day, divided into three doses.

Outcomes

Primary Outcome Measures

Liver functional restoration
Serum-testing in patients with obstructive jaundice will include determination of bilirubin (total and direct fractions), alanine transaminase (ALT), aspartate transaminase (AST), gama-glutamyl transpeptidase (GGT), alkaline phosphatase, albumin, and cholesterol levels.

Secondary Outcome Measures

To assess that in which functional parameters of the liver, treatment with UDCA will have greater impact
determination of bilirubin (total and direct fractions), alanine transaminase (ALT), aspartate transaminase (AST), gama-glutamyl transpeptidase (GGT), alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic or surgical intervention, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or surgical intervention.

Full Information

First Posted
September 11, 2012
Last Updated
October 1, 2012
Sponsor
University Clinical Centre of Kosova
Collaborators
University of Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT01688375
Brief Title
The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients With Obstructive Jaundice
Official Title
The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients With Obstructive Jaundice After Endoscopic or Surgical Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Clinical Centre of Kosova
Collaborators
University of Zagreb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
ABSTRACT: In patients with obstructive jaundice, multi-organ dysfunction may develop. The aim of this study is to evaluate the effect of ursodeoxycholic acid on liver functional restoration on patients with obstructive jaundice after surgical or endoscopic treatment. Patients with obstructive jaundice will be divided into two groups: (A) test group in which will be administered ursodeoxycholic acid twenty-four hours after endoscopic or surgical procedure and will last fourteen days, and (B) control group. Serum-testing will include determination of bilirubin, alanine transaminase, aspartate transaminase, gama-glutamyl transpeptidase, alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic or surgical procedure, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or surgical intervention. Our hypothesis is that patients with obstructive jaundice under treatment with ursodeoxycholic acid will have better outcome than patients in control group.
Detailed Description
Study objectives: This trial will be a prospective, an open, randomized and controlled study. The objective will be to evaluate the effect of ursodeoxycholic acid (UDCA) in the functional restoration of the liver in patients with obstructive jaundice in the early post-endoscopic or post-surgical phase. Study design: After diagnosis, patients with obstructive jaundice will be divided into two groups: (A) the test group in which will be administered UDCA in the early phase after endoscopic or surgical treatment, and (B) control group, in which no treatment will be applied with UDCA. Diagnostic methods will be biochemical findings, ultrasound examination, endoscopic retrograde cholangio pancreatography (ERCP), CT-scan and magnetic resonance cholangio pancreatography (MRCP). Serum-testing in patients with obstructive jaundice will include determination of bilirubin (total and direct fractions), alanine transaminase (ALT), aspartate transaminase (AST), gama-glutamyl transpeptidase (GGT), alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic or surgical intervention, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or surgical intervention. Endoscope and surgical procedures that will end with the external derivation of bile will be named as the external bile drainage, and indeed, while endoscope and surgical procedures that will make the internal derivation of bile shall be named as the internal bile drainage. UDCA administration: UDCA administration will begin twenty-four hours after endoscopic or surgical procedure and will last fourteen days. UDCA dose will be administered at 750 mg/day, divided into three doses. Power of the study: A clinically relevant improvement of liver functional tests is defined as an improvement of 80% of liver functional tests in test group, and an improvement only 40% in control group. In our study, to have an 80% chance of detecting a 50% difference between two groups on improvement of liver functional tests at an alpha level of 0.05, the power calculation indicates that each of the two groups should have at least 27 patients. Data sources and search strategy: An electronic search was performed on PubMed (from 1 January 1985 to 1 February 2012). A combination of keywords and MeSH terms where: 'ursodeoxycholic acid' AND 'obstructive jaundice', 'obstructive jaundice' AND 'liver function tests', 'obstructive jaundice' AND 'acute renal failure'. I have used , also, limits: Type of article ( selection was- clinical trial, meta-analyses), Species( selection was- human, animals), Text options ( selection was- links to free full text, abstract), Languages( English), Sex ( male, female), Age ( all adult 19+ years), Field ( all fields). Randomization: Patients have to sign an informed consent for the involving in the trial a day before endoscopic or surgical procedure. Randomisation will be performed at the time of transfer to the endoscope or operating room. Ethics: This study will be realized in the Surgery Clinic (Department of Abdominal Surgery) at University Clinical Centre of Kosovo in Pristina. It will be conducted in accordance with the principles of the Declaration of Helsinki. This study will begin after approval of the study protocol by Medical Ethics Committee of the University Clinical Centre of Kosovo( Faculty of Medicine). Data collection and statistical analyses: Data including serum-test results will be collected in a computer secured study platform. These data will be collected continuously, for each patient, starting one day before endoscopic or surgical procedure until the last data fourteen days after intervention. X2-analysis or Fisher exact test will perform to test the differences in proportions of qualitative variables between groups. Mann Whitney U test and Kruskal Wallis test will use for testing the difference between quantitative variables when distribution is not normal and Student t-test or ANOVA test when distribution is normal. The level P<0.05 will consider as the cut-off value for significance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Jaundice
Keywords
obstructive jaundice, ursodeoxycholic acid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ursodeoxycholic acid
Arm Type
Experimental
Arm Description
Ursodeoxycholic acid administration UDCA administration will begin twenty-four hours after endoscopic or surgical procedure and will last fourteen days. UDCA dose will be administered at 750 mg/day, divided into three doses.
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid
Other Intervention Name(s)
Ursofalk, UDCA
Intervention Description
UDCA administration will begin twenty-four hours after endoscopic or surgical procedure and will last fourteen days. UDCA dose will be administered at 750 mg/day, divided into three doses.
Primary Outcome Measure Information:
Title
Liver functional restoration
Description
Serum-testing in patients with obstructive jaundice will include determination of bilirubin (total and direct fractions), alanine transaminase (ALT), aspartate transaminase (AST), gama-glutamyl transpeptidase (GGT), alkaline phosphatase, albumin, and cholesterol levels.
Time Frame
Within 14 days after treatment with ursodeoxycholic acid
Secondary Outcome Measure Information:
Title
To assess that in which functional parameters of the liver, treatment with UDCA will have greater impact
Description
determination of bilirubin (total and direct fractions), alanine transaminase (ALT), aspartate transaminase (AST), gama-glutamyl transpeptidase (GGT), alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic or surgical intervention, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or surgical intervention.
Time Frame
within 14 days after treatment with ursodeoxycholic acid

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with obstructive jaundice Serum bilirubin level higher than 50 micromole/l 19+ years of age written informed consent Exclusion criteria: Cholangitis Acute pancreatitis pregnant women women during the breastfeeding suspected or proven primary liver diseases My family members Patients who are unable to understand our study purpose
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enver H Fekaj, PhD student
Phone
+37744279296
Email
enverfekaj@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enver H Fekaj, PhD student
Organizational Affiliation
University clinical centre of Kosovo, Department of surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University clinical centre of Kosovo, Department of general surgery
City
Pristina
State/Province
Kosovo
ZIP/Postal Code
10000
Country
Serbia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enver H Fekaj, PhD student
Phone
37744279296
Email
enverfekaj@hotmail.com
First Name & Middle Initial & Last Name & Degree
Enver H Fekaj, PhD student
Facility Name
University clinical centre of Kosovo
City
Pristina
State/Province
Kosovo
ZIP/Postal Code
10000
Country
Serbia
Facility Name
University clinical centre of Kosovo
City
Pristina
State/Province
Kosovo
ZIP/Postal Code
10000
Country
Serbia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enver H Fekaj, PhD student
Phone
37744279296
Email
enverfekaj@hotmail.com

12. IPD Sharing Statement

Citations:
Citation
1. Roche SP, Kobos R. Jaundice in the adult patient. Am Fam Physician. 2004; 69(2):299-304. 2. Rerknimitr R, Kullavanijaya P. Operable malignant jaundice: To stent or not to stent before the operation? World J Gastrointest Endosc. 2010; 2(1):10-4. 3.Yi-Jun Y, Jing-Sen SH, Shu-Min X, De-Ting ZH, Bing-Sheng C. Effects of different drainage procedures on levels of serum endotoxin and tumor necrosis factor in patients with malignant obstructive jaundice. HBPD Int. 2003;2:426-30. 4.Scott-Conner CE, Grogan JB. The pathophysiology of biliary obstruction and its effect on phagocytic and immune function. J Surg Res. 1994;57(2):316-36. 5.Assimakopoulos SF, Scopa ChD, Vaginos CE. Pathophysiology of increased intestinal permeability in obstructive jaundice. World J Gastroenterol. 2007;13(48):6458-64.
Results Reference
background
PubMed Identifier
24053627
Citation
Fekaj E, Gjata A, Maxhuni M. The effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment: a prospective, randomized, and controlled study. BMC Surg. 2013 Sep 22;13:38. doi: 10.1186/1471-2482-13-38.
Results Reference
derived

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The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients With Obstructive Jaundice

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