Usability of Ringed Polytetrafluoroethylene Graft for Venous Vascular Reconstruction of Living Donor Liver Transplantation
NCT ID: NCT01205802
Last Updated: 2010-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2010-08-31
2012-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PTFE group
MHV reconstruction with ringed Goretex
MHV reconstruction
MHV reconstruction with PTFE or homograft
Homograft group
MHV reconstruction with homograft
MHV reconstruction
MHV reconstruction with PTFE or homograft
Interventions
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MHV reconstruction
MHV reconstruction with PTFE or homograft
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Asan Medical Center
Locations
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Asan Medical Center
Seoul, Seoul, South Korea
Countries
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References
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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.
Other Identifiers
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MHV_Goretex_LDLT
Identifier Type: -
Identifier Source: org_study_id