NCT03893773

Brief Summary

Graft ischemia after liver transplantation is associated with a high incidence of morbidity and mortality . The overall incidence of vascular complications in adults varies widely among transplant centers worldwide, but remains around 7% in various series of deceased donor liver transplantation (DDLT), and around 13% involving living donor liver transplantation (LDLT) Vascular complications include; hepatic artery thrombosis and stenosis, portal vein thrombosis and stenosis, caval and hepatic veins obstruction, arterial pseudo aneurysm. Biliary complications include; biliary leakage, stricture and obstruction .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

2.1 years

First QC Date

March 24, 2019

Last Update Submit

March 26, 2019

Conditions

Liver Transplant, Complications

Outcome Measures

Primary Outcomes (2)

  • Incidence of vascular complication:

    A. Hepatic artery thrombosis (HAT), stenosis (HAS). B. Portal vein thrombosis (PVT), or stenosis. C. Hepatic veins and inferior vena cava thrombosis, or stenosis. The investigator will record nature of the complication, time of presentation and Number of hospital re-admissions (due to vascular complications).

    6 month after liver transplantation.

  • Intervention done due to vascular complication

    Non-surgical intervention (percutaneous transluminal angioplasty (PTA) +/- stent placement, catheter-directed thrombolysis, thrombectomy, trans-catheter arterial embolization) or surgical revision with detailed description of each intervention and if the intervention is successful or not (improvement of symptom and liver function).

    6 month after liver transplantation

Interventions

doppler ultrasonagraphyDEVICE

The following parameters will be measured: Hepatic artery Resistance index (HARI), Diameter, peak systolic velocity (HAPSV, cm/s). Portal vein peak velocity (PVPV) and diameter at the anastomotic and non-anastomotic sites. Hepatic vein peak velocity and wave form

Eligibility Criteria

Age18 Years - 70 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-Rajhi liver hospital, Assiut, Egypt

You may qualify if:

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

You may not qualify if:

  • Pediatric liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

March 24, 2019

First Posted

March 28, 2019

Study Start

April 1, 2019

Primary Completion

April 30, 2021

Study Completion

June 30, 2021

Last Updated

March 28, 2019

Record last verified: 2019-03