Prospective Randomized Study Comparing ePTFE Versus Dacron Graft for Anterior Sector Venous Drainage in Right Lobe Living Donor Liver Transplantation

Prospective Randomized Study Comparing ePTFE Versus Dacron Graft Donor Liver Transplantation

Living donor liver transplantation (LDLT) using the right lobe (RL) has created a significant increase in graft supply worldwide. However, it is a technically demanding procedure particularly because of the unique functional anatomic characteristics of hepatic venous drainage [1].

Study Overview

• Status: Unknown
• Conditions: Patency and Infection Rates Due to Usage of PTFE vs.Dacron Grafts
• Intervention / Treatment: Procedure: Active Comparator: ePTFE graft

Detailed Description

In the absence of an adequate drainage of the anterior sector (AS) veins, the consequent venous congestion in the RL graft may result in impaired graft regeneration, immediate liver dysfunction, and graft loss even in a liver graft of adequate size [2]. To overcome this problem, Lee et al. [3] introduced the concept of modified RL graft in which the branches of the middle hepatic vein (MHV) was drained using interposition vascular grafts. Although, the issue of when and how the MHV branches should be drained has been controversial since then, reconstruction of segment 5 and 8 veins using an interposition graft has become a standard procedure during RL LDLT. The vascular graft of choice in this procedure has been cryopreserved homologous vein graft, which provides excellent patency with low infection risk. However, such grafts are often unavailable, particularly in programs where deceased donors are scarce and surgeons must rely on synthetic grafts such as expanded polytetrafluoroethylene (ePTFE) and polyethylene terephthalate (Dacron®). Since we have developed an "intent-to-drain" policy in our LDLT program, we have been using Dacron grafts exclusively [4]. Although, complications such as early graft thrombosis, graft infection, and hollow viscous migration remain as major concerns, the safety and efficacy of both ePTFE and Dacron grafts in LDLT has been proven [5, 6]. However, to date, none of the previous studies have specifically compared these two different prosthetic materials, addressing graft patency and complication rates in patients undergoing LDLT. The aim of our study is to compare AS venous outflow reconstruction using ePTFE vs. Dacron grafts for their patency and infection rates and outcomes with respect to graft and patient survival in RL LDLT.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ATIF TEKIN, M.D.; Phone Number: +905321007771; Email: dr.atiftekin@gmail.com
• Study Contact Backup: Name: Mahmut Zenciroglu, M.D.; Phone Number: +905064919779; Email: mahmutzenciroglu@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34214
    • Recruiting
    • Medipol University Faculty of Medicine
    • Contact: ATIF TEKIN, M.D.; Phone Number: +905321007771; Email: dr.atiftekin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Primary Adult Living Donor Liver Transplantation
2. Right Lobe graft with anterior sector venous outflow reconstruction -

Exclusion Criteria:

1. Right Lobe graft without anterior sector venous outflow reconstruction
2. Liver re-transplantation -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ePTFE graft; In this group, anterior sector of the right lobe graft will be reconstructed using ePTFE vascular grafts	Procedure: Active Comparator: ePTFE graft; In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts; Other Names: Other: Dacron graft
Other: Dacron graft; In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts	Procedure: Active Comparator: ePTFE graft; In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts; Other Names: Other: Dacron graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft patency at 6-month posttransplant	Graft Patency	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft-related complications	Rate of graft infection	One Year
Graft survival	Morbidity	One year
Patient survival	Mortality	One Year
Graft regeneration rate	Graft regeneration	6 months

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Murat Dayangac, M.D., Study Chief

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Anticipated): September 24, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 26, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Medipol Transplant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No