AzTrials
AzTrials

Patency, Hepatic Venous CongestionPhase 2/3MHVLDLTNCT01205802

Usability of Ringed Polytetrafluoroethylene Graft for Venous Vascular Reconstruction of Living Donor Liver Transplantation

A Phase 2/3 study testing MHV reconstruction in people with Patency, Hepatic Venous Congestion, run by Asan Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Middle hepatic vein (MHV) reconstruction with an interposition vessel graft has been settled as a standard procedure for living donor liver transplantation (LDLT) using a right lobe graft. Read more about this study

Who is it for?
Any age
Conditions the study is for
Patency, Hepatic Venous Congestion
What is being tested?
MHV reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteSouth Korea
Study dates
Aug 2010to Jul 2012
Phase
Phase 2/3
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Living donor liver transplantation requiring MHV reconstruction

Who cannot join

  • Living donor liver transplantation not requiring MHV reconstruction

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Asan Medical Center

    Seoul, Seoul, 138-736

Other trials in South Korea

About this study

Official title: Prospective Study on Usability of Ringed Polytetrafluoroethylene Graft for Venous Vascular Reconstruction of Living Donor Liver Transplantation

Middle hepatic vein (MHV) reconstruction with an interposition vessel graft has been settled as a standard procedure for living donor liver transplantation (LDLT) using a right lobe graft. Increasing demand of vessel graft in the situation of limited resources of allograft led the investigators to search for new vessel substitutes. Since the use of thin-walled expanded polytetrafluoroethylene (PTFE) graft showed poor long-term patency, a prospective study is going to be performed to enhance the clinical usability of expanded PTFE graft. A clinical study intends to know how to maintain its luminal flow effectively by using ringed PTFE graft. During 12 months of study period, ringed PTFE graft will be used for reconstruction of MHV reconstruction. The investigators expect that ringed PTFE graft seems to be a more useful alternative than usual PTFE graft when adequate autologous or allogenic vessel graft is not available.

Read the detailed description

Since late 2009, the relative supply of vessel allograft over the increasing demand on LDLT became seriously shortened in the investigators' institution. Thus the investigators decide to use prosthetic vascular grafts more frequently than before. After a preliminary study from January 2010 to July 2010, a prospective case-controlled study will be performed for 12 months from August 2010 to July 2011.

The case number of patients requiring MHV reconstruction is expected as being 200 during the study period. Of them, currently using homologous or autologous vessel grafts will be used for 150. Due to expected shortage of such human vessels, other 50 will undergo MHV reconstruction using ringed PTFE graft in addition to available autologous or homologous vessel segments.

According to the implications from precedent animal and preliminary studies, the investigators set up the institutional guidelines for use of prosthetic vascular graft during MHV reconstruction of LDLT as follows: use only ringed PTFE graft; choose graft of a larger-caliber (≥1 cm); apply an intervening patch when making an end-to-side anastomosis for MHV branch of the segment 8 (V8); provide a slight redundancy in length; make the IVC-side orifice much larger than the usual; perform flow surveillance more frequently with dynamic CT scan and Doppler ultrasonography; place a stent as soon as any significant luminal narrowing is detected; and keep hypocoagulable state for at least 2 weeks and anti-platelet therapy for 6 months.

Technical knacks for secure suture include minimal removal of the rings attached at the surface of the ringed PTFE, use of PTFE suture material (GORE-TEX SUTURE; GORE-TEX, W.L. Gore \& Associated, Inc., USA) - a non-absorbable monofilament made of expanded PTFE enabling 1:1 needle to thread ratio to minimize needle hole bleeding at anastomoses, making a redundant patch plasty for end-to-side branch anastomosis especially for V8, and spray application of fibrin glues for suture-point minute bleedings and for stable fixation of PTFE graft at the liver cut surface.

The primary goal for this clinical study is set to keep up the rate of luminal patency as 100% for at least 1 month after MHV reconstruction for LDLT. Any occurrence of flow disturbance at luminal narrowing greater than 50% of the original cross-sectional area at 1 month should make the guidelines revise extensively. This protocol is designed as being a prospective case-controlled study for 1 year.

The use of PTFE graft for various hepatobiliary surgical procedures including LDLT has been permissible in the investigators' institution. Only after parenchymal transection of the donor liver, the size and shape of suitable vessel allograft for MHV reconstruction is determined. Thus the use of PTFE graft will be decided at this time after checking the list of all available allograft stored at the institutional tissue bank. The indication of PTFE use will be confined to the occasions that adequate allograft was not available. Permission for potential use of PTFE graft will be obtained from all cases of LDLT using a right lobe graft. This study protocol is approved by the institutional review board for clinical study.

Being tested
MHV reconstruction
Keywords
patency, hepatic venous congestion, liver transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MHV reconstructionProcedure or surgery

    MHV reconstruction with PTFE or homograft

Study groups in NCT01205802
Study groupRoleWhat they receive
PTFE groupActive comparatorMHV reconstruction with ringed Goretex
Receives: Procedure: MHV reconstruction
Homograft groupPlacebo comparatorMHV reconstruction with homograft
Receives: Procedure: MHV reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patency of the reconstructed MHV

    Patency rate up to 1 year

    Measured: Follow-up for 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJul 2011 (estimated)
  4. Study completionJul 2012 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01205802
Sponsor's protocol ID
MHV_Goretex_LDLT
Acronym
MHVLDLT
Status last verified
Sep 2010
First submitted
20 Sep 2010
Last updated
21 Sep 2010
Results posted
No
Data monitoring committee
No

Publications

  • Hwang S, Jung DH, Ha TY, Ahn CS, Moon DB, Kim KH, Song GW, Park GC, Jung SW, Yoon SY, Namgoong JM, Park CS, Park YH, Park HW, Lee HJ, Lee SG. Usability of ringed polytetrafluoroethylene grafts for middle hepatic vein reconstruction during living donor liver transplantation. Liver Transpl. 2012 Aug;18(8):955-65. doi: 10.1002/lt.23456.

    PubMed 22511404

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MHV reconstruction in people with Patency, Hepatic Venous Congestion, run by Asan Medical Center at 1 site in South Korea.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Sep 2010. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Patency of the reconstructed MHV (time frame: Follow-up for 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01205802, which also lists 1 linked publication.

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 21 Sep 2010.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in