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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Enver Fekaj, University Clinical Centre of Kosova.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01688375
First Posted: September 19, 2012
Last Update Posted: October 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Zagreb
Information provided by (Responsible Party):
Enver Fekaj, University Clinical Centre of Kosova
  Purpose

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.


Condition Intervention Phase
Obstructive Jaundice Drug: Ursodeoxycholic Acid Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients With Obstructive Jaundice After Endoscopic or Surgical Treatment

Resource links provided by NLM:


Further study details as provided by Enver Fekaj, University Clinical Centre of Kosova:

Primary Outcome Measures:
  • Liver functional restoration [ Time Frame: Within 14 days after treatment with ursodeoxycholic acid ]
    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 [ Time Frame: within 14 days after treatment with ursodeoxycholic acid ]
    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.


Estimated Enrollment: 54
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ursodeoxycholic acid
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.
Drug: Ursodeoxycholic Acid
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.
Other Name: Ursofalk, UDCA

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688375


Contacts
Contact: Enver H Fekaj, PhD student +37744279296 enverfekaj@hotmail.com

Locations
Serbia
University clinical centre of Kosovo, Department of general surgery Not yet recruiting
Pristina, Kosovo, Serbia, 10000
Contact: Enver H Fekaj, PhD student    37744279296    enverfekaj@hotmail.com   
Principal Investigator: Enver H Fekaj, PhD student         
University clinical centre of Kosovo
Pristina, Kosovo, Serbia, 10000
University clinical centre of Kosovo Not yet recruiting
Pristina, Kosovo, Serbia, 10000
Contact: Enver H Fekaj, PhD student    37744279296    enverfekaj@hotmail.com   
Sponsors and Collaborators
University Clinical Centre of Kosova
University of Zagreb
Investigators
Principal Investigator: Enver H Fekaj, PhD student University clinical centre of Kosovo, Department of surgery
  More Information

Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Enver Fekaj, General surgeon, PhD student, University Clinical Centre of Kosova
ClinicalTrials.gov Identifier: NCT01688375     History of Changes
Other Study ID Numbers: E25071969F
EN1969FE ( Other Identifier: University clinical centre of Kosovo )
First Submitted: September 11, 2012
First Posted: September 19, 2012
Last Update Posted: October 2, 2012
Last Verified: September 2012

Keywords provided by Enver Fekaj, University Clinical Centre of Kosova:
obstructive jaundice
ursodeoxycholic acid

Additional relevant MeSH terms:
Jaundice
Jaundice, Obstructive
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents