- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03789383
Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation
July 1, 2019 updated by: Sara Ali Hassan, Assiut University
Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation in Al-Rajhy Liver Hospital in Upper Egypt.
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:
- Detect frequency, risk factors for development of biliary complications post living donor liver transplantation, types (stricture anastomotic or not, leak, biloma, stone, cholangitis etc.…).
- Evaluate outcomes of different biliary complications
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Assiut, Egypt
- Al-Rajhy liver hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults more than 18 y with living donor liver transplantation in Al-Rajhy liver hospital, Assiut university, Egypt.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of biliary complications
Time Frame: 1 year after liver transplantation
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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.
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1 year after liver transplantation
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Type of intervention done to each complication
Time Frame: 1 year after liver transplantation
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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)
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1 year after liver transplantation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2020
Primary Completion (Anticipated)
December 30, 2021
Study Completion (Anticipated)
February 1, 2022
Study Registration Dates
First Submitted
December 25, 2018
First Submitted That Met QC Criteria
December 26, 2018
First Posted (Actual)
December 28, 2018
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 1, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- RFLTIUNE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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