Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis

Sponsor
Elvan Onur Kirimker (Other)
Overall Status
Completed
CT.gov ID
NCT05132192
Collaborator
Ankara University (Other), Ankara Guven Hospital (Other)
335
93.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: living donor liver transplantation
  • Procedure: Thrombectomy or interposition graft

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 Design

Study Type:
Observational
Actual Enrollment :
335 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Outcomes of Surgical Strategies for Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jul 30, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Survival [Time (days) from post transplant day1 to post transplant1 year]

    Posttransplant survival time

Secondary Outcome Measures

  1. Complications [From posttransplant day1 to post-transplant 30th day]

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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients underwent liver transplantation
Exclusion Criteria:
  • Pediatric liver transplants

  • Deceased donor liver transplants

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Elvan Onur Kirimker
  • Ankara University
  • Ankara Guven Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elvan Onur Kirimker, Attending surgeon at Dept of Surgery, Ankara University
ClinicalTrials.gov Identifier:
NCT05132192
Other Study ID Numbers:
  • PVT-LDLT-ANK
First Posted:
Nov 24, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elvan Onur Kirimker, Attending surgeon at Dept of Surgery, Ankara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021