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

Patency and Infection Rates Due to Usage of PTFE vs.Dacron Grafts Clinical Trial

Official title:

Prospective Randomized Study Comparing ePTFE Versus Dacron Graft Donor Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654728
• Other study ID #: Medipol Transplant
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2020
• Source: Istanbul Medipol University Hospital
• Contact: ATIF TEKIN, M.D.
• Phone: +905321007771
• Email: dr.atiftekin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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].

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 30, 2022
• Est. primary completion date: September 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Patency and Infection Rates Due to Usage of PTFE vs.Dacron Grafts

Intervention

Procedure:
• Active Comparator: ePTFE graft
In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts

Locations

Country	Name	City	State
Turkey	Medipol University Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft patency at 6-month posttransplant	Graft Patency	6 months
Secondary	Graft-related complications	Rate of graft infection	One Year
Secondary	Graft survival	Morbidity	One year
Secondary	Patient survival	Mortality	One Year
Secondary	Graft regeneration rate	Graft regeneration	6 months