Patency and Infection Rates Due to Usage of PTFE vs.Dacron GraftsNCT04654728
Prospective Randomized Study Comparing ePTFE Versus Dacron Graft for Anterior Sector Venous Drainage in Right Lobe Living Donor Liver Transplantation
A study testing Active Comparator: ePTFE graft in people with Patency and Infection Rates Due to Usage of PTFE vs.Dacron Grafts, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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]. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patency and Infection Rates Due to Usage of PTFE vs.Dacron Grafts
- What is being tested?
- Active Comparator: ePTFE graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Adult Living Donor Liver Transplantation
- Right Lobe graft with anterior sector venous outflow reconstruction -
Who cannot join
- Right Lobe graft without anterior sector venous outflow reconstruction
- Liver re-transplantation -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol University Faculty of Medicine
Istanbul, 34214
About this study
Official title: 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].
Read the 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.
- Being tested
- Active Comparator: ePTFE graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: ePTFE graftProcedure or surgery
Also called Other: Dacron graft
In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts
| Study group | Role | What they receive |
|---|---|---|
| ePTFE graft | Active comparator | In this group, anterior sector of the right lobe graft will be reconstructed using ePTFE vascular grafts Receives: Procedure: Active Comparator: ePTFE graft |
| Dacron graft | Other | In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts Receives: Procedure: Active Comparator: ePTFE graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency at 6-month posttransplant
Graft Patency
Measured: 6 months
Secondary outcomes (4)
Graft-related complications
Rate of graft infection
Measured: One Year
Graft survival
Morbidity
Measured: One year
Patient survival
Mortality
Measured: One Year
Graft regeneration rate
Graft regeneration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start2 Dec 2020
- Primary completion24 Sep 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patency and Infection Rates Due to Usage of PTFE vs.Dacron GraftsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be equally randomized into two groups using sealed envelope system. For anterior sector venous drainage, ePTFE vascular grafts (straight or bifurcated) in group 1, and Dacron grafts(straight or bifurcated) in 2 will be used as conduit.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ATIF TEKIN, Istanbul Medipol University Hospital
- Investigators
- Murat Dayangac, M.D., Study director, Study Chief
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654728
- Sponsor's protocol ID
- Medipol Transplant
- Status last verified
- May 2025
- First submitted
- 23 Nov 2020
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing ePTFE Versus Dacron Graft Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT04654728
- Acronym / sponsor ID
- Medipol Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 24 Sep 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be equally randomized into two groups using sealed envelope system. For anterior sector venous drainage, ePTFE vascular grafts (straight or bifurcated) in group 1, and Dacron grafts(straight or bifurcated) in 2 will be used as conduit.
| Arm | Type | Receives |
|---|---|---|
| ePTFE graft | Active comparator | Procedure: Active Comparator: ePTFE graftIn this group, anterior sector of the right lobe graft will be reconstructed using ePTFE vascular grafts |
| Dacron graft | Other | Procedure: Active Comparator: ePTFE graftIn this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary Adult Living Donor Liver Transplantation
- Right Lobe graft with anterior sector venous outflow reconstruction -
Key exclusion criteria (2 listed)
- Right Lobe graft without anterior sector venous outflow reconstruction
- Liver re-transplantation -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: ePTFE graftAlso: Other: Dacron graftIn this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts | Procedure or surgery | Dacron graft, ePTFE graft |
Primary outcome
Graft patency at 6-month posttransplant
Time frame: 6 months
Graft Patency
4 secondary outcomes
Graft-related complications
Time frame: One Year
Graft survival
Time frame: One year
Patient survival
Time frame: One Year
Graft regeneration rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Dayangac, M.D. study director
Study Chief
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: ePTFE graft in people with Patency and Infection Rates Due to Usage of PTFE vs.Dacron Grafts, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft patency at 6-month posttransplant (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.