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

NCT01688375 | Unknown Phase 2

• 2 other identifiers: E25071969FEN1969FE
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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.

Conditions

Obstructive Jaundice

Keywords

obstructive jaundice; ursodeoxycholic acid

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 14 days after treatment with ursodeoxycholic acid

Secondary Outcomes (1)

• To assess that in which functional parameters of the liver, treatment with UDCA will have greater impact

  within 14 days after treatment with ursodeoxycholic acid

Study Arms (1)

Ursodeoxycholic acid

EXPERIMENTAL

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

Interventions

Ursodeoxycholic Acid DRUG

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.

Also known as: Ursofalk, UDCA

Ursodeoxycholic acid

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Clinical Centre of Kosova: lead
• University of Zagreb: collaborator

Study Sites (3)

University clinical centre of Kosovo, Department of general surgery

Pristina, Kosovo, 10000, Serbia

Location

University clinical centre of Kosovo

Pristina, Kosovo, 10000, Serbia

Location

University clinical centre of Kosovo

Pristina, Kosovo, 10000, Serbia

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 24053627 DERIVED

MeSH Terms

Conditions

Jaundice, Obstructive

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Enver H Fekaj, PhD student

  University clinical centre of Kosovo, Department of surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enver H Fekaj, PhD student

CONTACT

+37744279296; enverfekaj@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General surgeon, PhD student

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 19, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 2, 2012

Record last verified: 2012-09

Locations

SE (3)