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OpenTrials
Completed

NCT Number: NCT05132192

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients underwent liver transplantation

Exclusion criteria

  • Pediatric liver transplants
  • Deceased donor liver transplants

Treatment and study plan

Living donor liver transplantation

Procedure

Living donor liver transplantation

Thrombectomy or interposition graft

Procedure

Portal flow restoration due to PVT in any manner

Primary outcomes

  1. Survival

    Time frame: Time (days) from post transplant day1 to post transplant1 year

    Posttransplant survival time

Secondary outcomes

  1. Complications

    Time frame: From posttransplant day1 to post-transplant 30th day

    Highest grade of complication after LDLT according to Dindo-Clavien Classification

  2. 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

Sponsors and collaborators

Lead sponsor

Elvan Onur Kirimker

Other

Collaborators

  • Ankara Guven Hospital
  • Ankara University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Nov 24, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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