NCT03789383

Brief 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. 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. 2.Evaluate outcomes of different biliary complications

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2024Jul 2027

First Submitted

Initial submission to the registry

December 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
5 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

December 25, 2018

Last Update Submit

July 21, 2025

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • pediatric liver transplantation
  • cadaveric liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alrajhy center for hepatobiliary disorders

Asyut, 71515, Egypt

RECRUITING

Al-Rajhy liver hospital

Asyut, Egypt

NOT YET RECRUITING

Central Study Contacts

Sara Sedeek

CONTACT

+201022177340sara_ali@aun.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical teaching assistant in department of Tropical Medicine and Gastroenterology

Study Record Dates

First Submitted

December 25, 2018

First Posted

December 28, 2018

Study Start

January 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)