Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation

Liver Transplant Clinical Trial

Official title:

Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation: Middle Hepatic Vein Reconstruction Versus Separate Tributaries to Inferior Vena Cava Anastomosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03666689
• Other study ID #: MHV reconstruction in LDLT
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: May 2021

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: Ahmed Abdalla, master
• Phone: +2001018942253
• Email: draboabdalla33[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Procedure:
• surgical technique
surgical reconstruction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outflow adequacy of liver graft within the first 6 month post transplant	Outflow adequacy of the graft will be assessed intraoperatively by the presence of the congestion and the color of the graft and Doppler ultrasound will be done after vascular reconstruction and before closure of anterior abdominal wall. Outflow adequacy will be assessed postoperatively by Doppler ultrasound once per day for the first 5 days, then once per week for 4 weeks then 2,3,and 6 months. Computed tomography (CT) scan will be done in the 6 postoperative month	6 month