Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis

NCT ID: NCT05132192

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2020-10-30

Brief Summary

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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

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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

Conditions

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Portal Vein Thrombosis Liver Transplant; Complications

Keywords

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Liver transplantation Portal vein thrombosis Thrombectomy Doppler flowmeter

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PVT

Patients with pretransplant portal vein thrombosis

living donor liver transplantation

Intervention Type PROCEDURE

Living donor liver transplantation

Thrombectomy or interposition graft

Intervention Type PROCEDURE

Portal flow restoration due to PVT in any manner

non-PVT

Patients without pretransplant portal vein thrombosis

living donor liver transplantation

Intervention Type PROCEDURE

Living donor liver transplantation

Interventions

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living donor liver transplantation

Living donor liver transplantation

Intervention Type PROCEDURE

Thrombectomy or interposition graft

Portal flow restoration due to PVT in any manner

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients underwent liver transplantation

Exclusion Criteria

* Pediatric liver transplants
* Deceased donor liver transplants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role collaborator

Ankara Guven Hospital

UNKNOWN

Sponsor Role collaborator

Elvan Onur Kirimker

OTHER

Sponsor Role lead

Responsible Party

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Elvan Onur Kirimker

Attending surgeon at Dept of Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Elvan O Kirimker, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara University

References

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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.

Reference Type BACKGROUND
PMID: 28834305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10830225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21183851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30230053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25822434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24299686 (View on PubMed)

Other Identifiers

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PVT-LDLT-ANK

Identifier Type: -

Identifier Source: org_study_id