NCT05132192

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
335

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

7.6 years

First QC Date

October 28, 2021

Last Update Submit

November 19, 2021

Conditions

Portal Vein ThrombosisLiver Transplant; Complications

Keywords

Liver transplantationPortal vein thrombosisThrombectomyDoppler flowmeter

Outcome Measures

Primary Outcomes (1)

  • Survival

    Posttransplant survival time

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

Secondary Outcomes (2)

  • Complications

    From posttransplant day1 to post-transplant 30th day

  • Flow

    Intraoperatively twice: before recipient hepatectomy (portal flow of diseased liver ) and at the end of transplantation procedure

Study Arms (2)

PVT

Patients with pretransplant portal vein thrombosis

Procedure: living donor liver transplantationProcedure: Thrombectomy or interposition graft

non-PVT

Patients without pretransplant portal vein thrombosis

Procedure: living donor liver transplantation

Interventions

living donor liver transplantationPROCEDURE

Living donor liver transplantation

PVTnon-PVT
Thrombectomy or interposition graftPROCEDURE

Portal flow restoration due to PVT in any manner

PVT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients underwent liver transplantation

You may not qualify if:

  • Pediatric liver transplants
  • Deceased donor liver transplants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Conzen KD, Pomfret EA. Liver transplant in patients with portal vein thrombosis: Medical and surgical requirements. Liver Transpl. 2017 Oct;23(S1):S59-S63. doi: 10.1002/lt.24856. No abstract available.

    PMID: 28834305BACKGROUND

  • Yerdel MA, Gunson B, Mirza D, Karayalcin K, Olliff S, Buckels J, Mayer D, McMaster P, Pirenne J. Portal vein thrombosis in adults undergoing liver transplantation: risk factors, screening, management, and outcome. Transplantation. 2000 May 15;69(9):1873-81. doi: 10.1097/00007890-200005150-00023.

    PMID: 10830225BACKGROUND

  • Ravaioli M, Zanello M, Grazi GL, Ercolani G, Cescon M, Del Gaudio M, Cucchetti A, Pinna AD. Portal vein thrombosis and liver transplantation: evolution during 10 years of experience at the University of Bologna. Ann Surg. 2011 Feb;253(2):378-84. doi: 10.1097/SLA.0b013e318206818b.

    PMID: 21183851BACKGROUND

  • Zanetto A, Rodriguez-Kastro KI, Germani G, Ferrarese A, Cillo U, Burra P, Senzolo M. Mortality in liver transplant recipients with portal vein thrombosis - an updated meta-analysis. Transpl Int. 2018 Dec;31(12):1318-1329. doi: 10.1111/tri.13353. Epub 2018 Oct 23.

    PMID: 30230053BACKGROUND

  • Qi X, Dai J, Jia J, Ren W, Yang M, Li H, Fan D, Guo X. Association between portal vein thrombosis and survival of liver transplant recipients: a systematic review and meta-analysis of observational studies. J Gastrointestin Liver Dis. 2015 Mar;24(1):51-9, 4 p following 59. doi: 10.15403/jgld.2014.1121.qix.

    PMID: 25822434BACKGROUND

  • Hibi T, Nishida S, Levi DM, Selvaggi G, Tekin A, Fan J, Ruiz P, Tzakis AG. When and why portal vein thrombosis matters in liver transplantation: a critical audit of 174 cases. Ann Surg. 2014 Apr;259(4):760-6. doi: 10.1097/SLA.0000000000000252.

    PMID: 24299686BACKGROUND

MeSH Terms

Interventions

Thrombectomy

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Elvan O Kirimker, MD

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending surgeon at Dept of Surgery

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 24, 2021

Study Start

January 1, 2013

Primary Completion

July 30, 2020

Study Completion

October 30, 2020

Last Updated

November 24, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Data will not be shared