Stented Biliary Anastomosis in Living Donor Liver Transplantation

May 14, 2020 updated by: Alaa Mstafa Hassan Sewefy

Randomized Controlled Clinical Trial Of Stented Versus Stentless Biliary Anastomosis In Living Donor Liver Transplantation

Determination of biliary complications in stented group compared to duct to duct anastomosis without stent

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

30 patients included in the study. patients will be randomly allocated in two equal groups. In group A anastomosis will be done on intraductal stent and in group B anastomosis done without stent .the patients will be followed for one year to compare the result of two groups as regard biliary complications.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • Egypt
      • Cairo, Egypt, 11865
        • Air force spcialized hospital

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients eligible for a liver transplantation
  • patients' written informed consent signed.

Exclusion Criteria:

  • biliary reconstruction requires a hepatico-jejunostomy for anatomical/biliary disease reason.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intraductal stent
in this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis with internal biliary stent
Procedure: living donor liver transplantation with internal biliary stent
living donor liver transplantation without internal biliary stent
ACTIVE_COMPARATOR: stentless
in this group ,patients candidate for living donor liver transplantation duct to duct biliary anastomosis will done without internal biliary
Procedure: living donor liver transplantation with internal biliary stent
living donor liver transplantation without internal biliary stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biliary complications after living donor liver transplantation
Time Frame: one year
incidence of biliary complications after living donor liver transplantation
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital stay
Time Frame: one month
hospital stay
one month
biliary complications
Time Frame: one year
types of biliary complications
one year
biliary related mortality
Time Frame: one year
mortality
one year
rate of cholangitis
Time Frame: 3 months
rate of cholangitis
3 months
time 2 biliary complications
Time Frame: one year
time 2 biliary complications
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
skeletonization of duct
Time Frame: 10 hours
skeletonization of duct
10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaa Mstafa Hassan Sewefy

Collaborators

Ain Shams University

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 (ACTUAL)

August 10, 2018

Primary Completion (ACTUAL)

November 10, 2019

Study Completion (ACTUAL)

November 10, 2019

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (ACTUAL)

August 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AS.fac.med.55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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