Liver TransplantNCT03666689
Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation
An observational study of Liver Transplant, run by Assiut University.
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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- surgical technique
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will included in the study all patients accepted for Living Donor Liver Transplantation (LDLT) according to hospital protocol
Who may be able to join
- 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
Who cannot join
- Acute fulminant liver failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation: Middle Hepatic Vein Reconstruction Versus Separate Tributaries to Inferior Vena Cava Anastomosis
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.
Read the 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.
- Conditions
- Liver Transplant
- Being tested
- surgical technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical techniqueProcedure or surgery
surgical reconstruction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abdalla, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666689
- Sponsor's protocol ID
- MHV reconstruction in LDLT
- Status last verified
- Sep 2018
- First submitted
- 9 Sep 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 9339932Fan 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.
PubMed 12832976Yi 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.
PubMed 17663413Hwang 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.
PubMed 22511404
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation: Middle Hepatic Vein Reconstruction Versus Separate Tributaries to Inferior Vena Cava Anastomosis
- ClinicalTrials.gov ID
- NCT03666689
- Acronym / sponsor ID
- MHV reconstruction in LDLT
- Conditions
- Liver Transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MHV reconstruction | – | Procedure: surgical techniqueBoth 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. |
| Separate tributaries reconstruction | – | Procedure: surgical techniqueEnd 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will included in the study all patients accepted for Living Donor Liver Transplantation (LDLT) according to hospital protocol
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Acute fulminant liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical techniquesurgical reconstruction | Procedure or surgery | MHV reconstruction, Separate tributaries reconstruction |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Background: PubMed 9339932Lo 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.
- Background: PubMed 12832976Fan 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.
- Background: PubMed 17663413Yi 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.
- Background: PubMed 22511404Hwang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdalla, master (+2001018942253, draboabdalla33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outflow adequacy of liver graft within the first 6 month post transplant (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666689, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.