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Open Access 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

Enver Fekaj1*, Arben Gjata2 and Mehmet Maxhuni1

Author Affiliations

1 Department of Abdominal Surgery, University Clinical Centre of Kosovo, Rrethi i Spitalit, str: p.n., Pristina 10000, Republic of Kosovo

2 Department of Surgery, University Clinical Centre, “Nene Tereza”, Rruga Dibres 370, Tirana, Albania

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BMC Surgery 2013, 13:38  doi:10.1186/1471-2482-13-38

Published: 22 September 2013

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

Keywords:
Obstructive jaundice; Ursodeoxycholic acid; Treatment with ursodeoxycholic acid