Clinical trial NCT03666689: Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation
Official title: Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation: Middle Hepatic Vein Reconstruction Versus Separate Tributaries to Inferior Vena Cava Anastomosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will included in the study all patients accepted for Living Donor Liver Transplantation (LDLT) according to hospital protocol

Brief summary: Modified Right Lobe Graft(MRLG) is one of the most common used graft in liver transplantation .Anterior sector of allograft in MRLG usually congested to decrease this congestion tributaries of middle hepatic vein should be drained to inferior vena cava .

There are too many techniques available for this drainage using either cryopreserved or synthetic graft for vascular anastomosis .In this study we will compare between two different technique using ringed synthetic polytetrafluoroethylene (PTFE) graft to assess outflow adequacy in both technique.

Detailed description: Comparative, prospective, observational, two-groups study. group 1 : Middle Hepatic Vein(MHV) will reconstructed by fashioning a PTFE graft of suitable size positioned parallel to the cut surface of the Modified Right Lobe Graft.This position theoretically make the PTFE graft in a position similar to MHV.Any vein \>4mm will be connected end to side fashion to the PTFE graft.The distal end of the PTFE graft will be closed by hemolock just distal to segment 5 vein .The proximal end of PTFE graft will be anastomosed to the recipient MHV orifice or MHV/lift orifice group 2: The end of segment 5 vein will be anastomosed to the end of suitable size PTFE graft which will be anastomosed to Inferior Vena Cava (IVC) directly and The end of segment 8 vein will be anastomosed to the end of suitable size PTFE graft which will be anastomosed to MHV or MHV/Lift orifice directly.the study will not be randomized .All operation will be done by tha same team .Choice of technique at surgeon discretion .Outflow adequecy will be assessed by Doppler Ultrasound intraoperatively and daily for 5 day once per week for 4 week and ,2,3,6,month.Progressive diminished flow or absent flow both will be considered as graft not patent .Markers of venous congestion will be considered as secondary outcome measure.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing Living Donor Liver Transplantation(LDLT) accepted according to hospital protocol
* Written informed consent obtained
* patient undergoing venous reconstruction either segment 5 or segment 8 vein or both

Exclusion Criteria:

* Acute fulminant liver failure

Primary outcomes:
measure: Outflow adequacy of liver graft within the first 6 month post transplant
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lo CM, Fan ST, Liu CL, Wei WI, Lo RJ, Lai CL, Chan JK, Ng IO, Fung A, Wong J. Adult-to-adult living donor liver transplantation using extended right lobe grafts. Ann Surg. 1997 Sep;226(3):261-9; discussion 269-70. doi: 10.1097/00000658-199709000-00005.
citation: Fan ST, Lo CM, Liu CL, Wang WX, Wong J. Safety and necessity of including the middle hepatic vein in the right lobe graft in adult-to-adult live donor liver transplantation. Ann Surg. 2003 Jul;238(1):137-48. doi: 10.1097/01.sla.0000077921.38307.16.
citation: Yi NJ, Suh KS, Lee HW, Cho EH, Shin WY, Cho JY, Lee KU. An artificial vascular graft is a useful interpositional material for drainage of the right anterior section in living donor liver transplantation. Liver Transpl. 2007 Aug;13(8):1159-67. doi: 10.1002/lt.21213.
citation: 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.