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BMC Surgery
Published in: BMC Surgery 1/2013

Open Access 01-12-2013 | Study protocol

The effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment: a prospective, randomized, and controlled study

Authors: Enver Fekaj, Arben Gjata, Mehmet Maxhuni

Published in: BMC Surgery | Issue 1/2013

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Abstract

Background

In patients with obstructive jaundice, multi-organ dysfunction may develop.

Methods/Design

This trial is a prospective, open-label, randomized, and controlled study with the objective to evaluate the effect of ursodeoxycholic acid in liver functional restoration in patients with obstructive jaundice after endoscopic treatment. The aim of this study is to evaluate the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment. The hypothesis of this trial is that patients with obstructive jaundice, in which will be administered UDCA, in the early phase after endoscopic intervention will have better and faster functional restoration of the liver than patients in the control group.
Patients with obstructive jaundice, randomly, will be divided into two groups: (A) test group in which will be administered ursodeoxycholic acid twenty-four hours after endoscopic procedure and will last fourteen days, and (B) control group.
Serum-testing will include determination of bilirubin, alanine transaminase, aspartate transaminase, gama-glutamil transpeptidase, alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic procedure, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic intervention.

Discussion

This trial is a prospective, open-label, randomized, and controlled study to asses the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice in the early phase after endoscopic treatment.

Trial registration

ClinicalTrials.gov, NCT01688375
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Metadata
Title
The effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment: a prospective, randomized, and controlled study
Authors
Enver Fekaj
Arben Gjata
Mehmet Maxhuni
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Surgery / Issue 1/2013
Electronic ISSN: 1471-2482
DOI
https://doi.org/10.1186/1471-2482-13-38

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