Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis

Liver Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05132192
• Other study ID #: PVT-LDLT-ANK
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2021
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: October 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients underwent liver transplantation

Exclusion Criteria:

• Pediatric liver transplants

• Deceased donor liver transplants

Related Conditions & MeSH terms

• Liver Transplant; Complications
• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• living donor liver transplantation
Living donor liver transplantation
• Thrombectomy or interposition graft
Portal flow restoration due to PVT in any manner

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Elvan Onur Kirimker	Ankara Guven Hospital, Ankara University

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Yerdel MA, Gunson B, Mirza D, Karayalçin 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Posttransplant survival time	Time (days) from post transplant day1 to post transplant1 year
Secondary	Complications	Highest grade of complication after LDLT according to Dindo-Clavien Classification	From posttransplant day1 to post-transplant 30th day
Secondary	Flow	Intraoperative portal flow measurements (ml/min) of diseased liver and transplanted liver with Doppler flowmeter	Intraoperatively twice: before recipient hepatectomy (portal flow of diseased liver ) and at the end of transplantation procedure