Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis

November 19, 2021 updated by: Elvan Onur Kirimker

Outcomes of Surgical Strategies for Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis

Data of demographic, clinical, laboratory and imaging studies of living donor liver transplantation (LDLT) recipients from two transplant centers were collected. Survival and morbidity rates between patients with and without portal vein thrombosis (PVT) were compared. Risk factors of mortality in the setting of PVT were identified. Intraoperative portal flow measurements were compared before and after portal flow restoration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

LDLTs performed in two experienced centers (Ankara University Ibn-i Sina Hospital and Ankara Güven Hospital) between January 2013 and February 2020 were evaluated and included in the cohort study. Deceased donor liver transplants and pediatric transplants (deceased or living) were excluded from the study.

Data relating to this study including patient history, preoperative laboratory and imaging test results, reports of surgical procedures or interventions, intraoperative anesthesia records, post-operative laboratory trends, and postoperative complications were extracted from the computer-based data management system and prospectively maintained in transplant databases in both centers. Recipients of LDLT were divided in two groups according to the presence or absence of PVT.

Portal flow measurements were recorded with VeriQ (Medistim ASA, Oslo, Norway) Doppler flowmeter device in one of the centers later in the study period.

The follow-up and recordings of the patients were maintained in the outpatient clinics of the two centers.

The most serious complication experienced by each patient was recorded according to the Clavien-Dindo classification Primary outcome of the current study was the survival rates of patients with and without PVT Secondary outcomes of the study included morbidity in patients with and without PVT after LDLT, risk factors of mortality after LDLT to patients with PVT and comparison of intraoperative portal flow measurements between patients with and without PVT

Study Type

Observational

Enrollment (Actual)

335

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients that who underwent living donor liver transplantation in the study period in the two centers

Description

Inclusion Criteria:

  • Patients underwent liver transplantation

Exclusion Criteria:

  • Pediatric liver transplants
  • Deceased donor liver transplants

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PVT
Patients with pretransplant portal vein thrombosis
Procedure: living donor liver transplantation
Living donor liver transplantation
Procedure: Thrombectomy or interposition graft
Portal flow restoration due to PVT in any manner
non-PVT
Patients without pretransplant portal vein thrombosis
Procedure: living donor liver transplantation
Living donor liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: Time (days) from post transplant day1 to post transplant1 year
Posttransplant survival time
Time (days) from post transplant day1 to post transplant1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: From posttransplant day1 to post-transplant 30th day
Highest grade of complication after LDLT according to Dindo-Clavien Classification
From posttransplant day1 to post-transplant 30th day
Flow
Time Frame: Intraoperatively twice: before recipient hepatectomy (portal flow of diseased liver ) and at the end of transplantation procedure
Intraoperative portal flow measurements (ml/min) of diseased liver and transplanted liver with Doppler flowmeter
Intraoperatively twice: before recipient hepatectomy (portal flow of diseased liver ) and at the end of transplantation procedure

Collaborators and Investigators

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

Sponsor

Elvan Onur Kirimker

Collaborators

Ankara University
Ankara Güven Hospital

Investigators

  • Principal Investigator: Elvan O Kirimker, MD, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2013

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVT-LDLT-ANK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared

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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