Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis

Completed

• Conditions: Liver Transplant; Complications; Portal Vein Thrombosis
• Interventions: Procedure: living donor liver transplantation; Procedure: Thrombectomy or interposition graft

• Registration Number: NCT05132192
• Lead Sponsor: Elvan Onur Kirimker

Brief Summary

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.

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 Timeline

• Study Start: 2013-01-01
• Primary Completion: 2020-07-30
• Study Completion: 2020-10-30
• Study First Submitted: 2021-10-28
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-19
• Last Update Submitted: 2021-11-19
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• Patients underwent liver transplantation

Exclusion Criteria

• Pediatric liver transplants
• Deceased donor liver transplants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PVT	Thrombectomy or interposition graft	Patients with pretransplant portal vein thrombosis
PVT	living donor liver transplantation	Patients with pretransplant portal vein thrombosis
non-PVT	living donor liver transplantation	Patients without pretransplant portal vein thrombosis

Primary Outcome Measures

Name	Time	Method
Survival	Time (days) from post transplant day1 to post transplant1 year	Posttransplant survival time

Secondary Outcome Measures

Name	Time	Method
Complications	From posttransplant day1 to post-transplant 30th day	Highest grade of complication after LDLT according to Dindo-Clavien Classification
Flow	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