NCT03666689

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 9, 2018

Last Update Submit

September 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

MHV reconstruction

Both ends of middle hepatic vein tributaries V8 and/or V5 of modified right lobe graft will be anastomosed to side of a single synthetic graft which will be anastomosed to recipient's middle/left hepatic vein orifice.

Procedure: surgical technique

Separate tributaries reconstruction

End of V8 middle hepatic vein tributary of modified right lobe graft; if present, will be anastomosed to end of a synthetic graft which will be anastomosed to recipient's middle/left hepatic vein orifice, and end of V5; if present; will be anastomosed to end of a synthetic graft which will be anastomosed to recipient's Inferior Vena Cava directly.

Procedure: surgical technique

Interventions

surgical reconstruction

MHV reconstructionSeparate tributaries reconstruction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will included in the study all patients accepted for Living Donor Liver Transplantation (LDLT) according to hospital protocol

You may qualify if:

  • 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

You may not qualify if:

  • Acute fulminant liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 9339932BACKGROUND
  • 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.

    PMID: 12832976BACKGROUND
  • 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.

    PMID: 17663413BACKGROUND
  • 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.

    PMID: 22511404BACKGROUND

MeSH Terms

Interventions

Wound Closure Techniques

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Ahmed Abdalla, master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

September 9, 2018

First Posted

September 12, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2020

Study Completion

May 1, 2021

Last Updated

September 12, 2018

Record last verified: 2018-09