Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT01205802 |
| Other study ID # |
MHV_Goretex_LDLT |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 2/Phase 3
|
| First received |
September 20, 2010 |
| Last updated |
September 20, 2010 |
| Start date |
August 2010 |
| Est. completion date |
July 2012 |
Study information
| Verified date |
September 2010 |
| Source |
Asan Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Republic of Korea: Asan Medical Center Institutional Review Board |
| Study type |
Interventional
|
Clinical 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. 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.
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.
