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Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation

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ClinicalTrials.gov Identifier: NCT03666689
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abdalla, Assiut University

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.


Condition or disease Intervention/treatment
Liver Transplant Procedure: surgical 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation: Middle Hepatic Vein Reconstruction Versus Separate Tributaries to Inferior Vena Cava Anastomosis
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
surgical reconstruction

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
surgical reconstruction




Primary Outcome Measures :
  1. Outflow adequacy of liver graft within the first 6 month post transplant [ Time Frame: 6 month ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666689


Contacts
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Contact: Ahmed Abdalla, master +2001018942253 draboabdalla33@gmail.com

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Ahmed Mohamed Abdalla, assisstant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03666689     History of Changes
Other Study ID Numbers: MHV reconstruction in LDLT
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No