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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03789383
Other study ID # RFLTIUNE
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date February 1, 2022

Study information

Verified date July 2019
Source Assiut University
Contact Sara Sedeek
Phone +201022177340
Email sara_ali@aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Liver transplantation (LT) is a live-saving therapy for patients with complicated chronic liver diseases and acute liver failure .Even though many complications can occur after LT, biliary complications (BC) are both common and potentially severe .

a prospective study and retrospective part from hospital records.

Aim of the study:

1. Detect frequency, risk factors for development of biliary complications post living donor liver transplantation, types (stricture anastomotic or not, leak, biloma, stone, cholangitis etc.…).

2. Evaluate outcomes of different biliary complications


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date February 1, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Adults more than 18 y with living donor liver transplantation in Al-Rajhy liver hospital , Assiut university,Egypt

Exclusion Criteria:

- pediatric liver transplantation

- cadaveric liver transplantation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Al-Rajhy liver hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of biliary complications Biliary complications include biliary leak or stricture (anastomotic or non anastomotic), the investigator will record nature of complication , its time of presentation and number of hospital re-admissions due to biliary complications. 1 year after liver transplantation
Primary Type of intervention done to each complication Intervention is either non surgical (ERCP or PTD) or surgical revision with detailed description of each intervention and if the intervention is successful or not (biliary stricture resolved by MRCP, improvement of liver functions and symptoms) 1 year after liver transplantation
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