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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01205802
First received: September 20, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Patency, Hepatic Venous Congestion
Procedure: MHV reconstruction
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study on Usability of Ringed Polytetrafluoroethylene Graft for Venous Vascular Reconstruction of Living Donor Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Patency of the reconstructed MHV [ Time Frame: Follow-up for 1 year ] [ Designated as safety issue: No ]
    Patency rate up to 1 year


Estimated Enrollment: 200
Study Start Date: August 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PTFE group
MHV reconstruction with ringed Goretex
Procedure: MHV reconstruction
MHV reconstruction with PTFE or homograft
Placebo Comparator: Homograft group
MHV reconstruction with homograft
Procedure: MHV reconstruction
MHV reconstruction with PTFE or homograft

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Living donor liver transplantation requiring MHV reconstruction

Exclusion Criteria:

  • Living donor liver transplantation not requiring MHV reconstruction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205802

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
  More Information

No publications provided by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shin Hwang / Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01205802     History of Changes
Other Study ID Numbers: MHV_Goretex_LDLT
Study First Received: September 20, 2010
Last Updated: September 20, 2010
Health Authority: Republic of Korea: Asan Medical Center Institutional Review Board

Keywords provided by Asan Medical Center:
patency, hepatic venous congestion, liver transplantation

Additional relevant MeSH terms:
Hyperemia
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014