| CTRI Number |
CTRI/2018/11/016315 [Registered on: 12/11/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare the difference between the outcomes of liver transplant between usage of synthetic graft(PTFE) vs native tissue graft(portal vein) |
|
Scientific Title of Study
|
Randomized Controlled Trial to compare Early Postoperative Outcomes of Polytetrafluoroethylene Graft Vs. Native Recipient Portal Vein fro Middle Hepatic Vein Reconstruction in the Recipient following Live Donor Liver Transplantation |
| Trial Acronym |
RePoVer Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MADHU SRINIVASAN DURAIRAJ |
| Designation |
M.Ch. Fellow |
| Affiliation |
AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
AMRITA LANE
PONEKKARA
EDAPPALLY
ERNAKULAM
KERALA
MADHU SURGICAL CLINIC AND HOSPITAL
399, PERUNDURAI ROAD
ERODE - 638011
Ernakulam
KERALA
682041
India |
| Phone |
|
| Fax |
|
| Email |
madhusrinivasand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUDHINDRAN SURRENDRAN |
| Designation |
PROFESSOR |
| Affiliation |
DEPARTMENT OF G.I SURGERY AND ORGAN TRANSPLANTATION |
| Address |
AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
AMRITA LANE
PONEKKARA
EDAPPALLY
ERNAKULAM
KERALA
Ernakulam
KERALA
682041
India |
| Phone |
919388623851 |
| Fax |
|
| Email |
sudhisalini@icloud.com |
|
Details of Contact Person
Public Query
|
| Name |
SUDHINDRAN SURRENDRAN |
| Designation |
PROFESSOR |
| Affiliation |
DEPARTMENT OF G.I. SURGERY AND ORGAN TRANSPLANTATION |
| Address |
AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
AMRITA LANE
PONEKKARA
EDAPPALLY
ERNAKULAM
KERALA
Ernakulam
KERALA
682041
India |
| Phone |
919388623851 |
| Fax |
|
| Email |
sudhisalini@icloud.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences Research Centre |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences Research Centre |
| Address |
DEPARTMENT OF G.I. SURGERY AND LIVER TRANSPLANTATION,
AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH
AMRITA LANE, PONEKKARA,
EDAPALLY,
ERNAKULAM,
KERALA - 682041 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DEPARTMENT OF GI SURGERY AND LIVER TRANSPLANTATION |
AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH,
AMRITA LANE, PONEKKARA
EDAPALLY
ERNAKULAM
KERALA - 682041 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MADHU SRINIVASAN DURAIRAJ |
AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
Tower 1, Floor 1, Department of G.I. SURGERY and ORGAN TRANSPLANTATION,
AMRITA LANE, PONEKKARA
EDAPALLY
ERNAKULAM
Ernakulam
KERALA |
9944143357
madhusrinivasand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
DECOMPENSATED CHRONIC LIVER DISEASE PATIENTS REQUIRING LIVER TRANSPLANTATION, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
POLYTETRAFLUOROEHTYLENE GRAFT |
USE OF PTFE GRAFT FOR RECONSTRUCTION OF MIDDLE HEPATIC VEIN IN THE MODIFIED RIGHT LOBE GRAFT IN A LIVE DONOR LIVER TRANSPLANTATION |
| Comparator Agent |
PORTAL VEIN FROM THE RECIPIENT EXPLANT LIVER |
USE OF PORTAL VEIN FROM THE EXPLANTED RECIPIENT LIVER FOR RECONSTRUCTION OF THE MIDDLE HEPATIC VEIN IN THE MODIFIED RIGHT LOBE GRAFT IN LIVE DONOR LIVER TRANSPLANTATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ADULT to ADULT LIVE DONOR LIVER TRANSPLANT PATIENTS with Decompensated Liver Disease (Acute/Subacute/Chronic)
Live Donor suitable for Right lobe donation with
1. Functional Liver Reserve > 30%
2. Adequate Segment 4 drainage to the Left Hepatic Vein
3. Steatosis < 20% assesses by Plain CT |
|
| ExclusionCriteria |
| Details |
PORTAL VEIN THROMBOSIS IN THE RECIPIENT
HEPATOCELLULAR CARCINOMA IN THE RECIPIENT
ABO Incompatible Transplants
DONOR - TYPE II or TYPE III Portal vein anatomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GRAFT PATENCY RATE assessed by DUPLEX ULTRASONOGRAM and confirmed with cross sectional imaging either CT or MRI in the event of thrombosis detected by Duplex |
First two weeks (daily doppler in the first week and alternate day doppler in the second week)
at weekly intervals till 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
GRAFT FUNCTION :
EARLY ALLOGRAFT DYSFUNCTION
PRIMARY NON FUNCTION
SMALL FOR SIZE DYSFUNCTION
|
First two weeks |
MORBIDITY :
Complications :
Infections (intra-abdominal and blood borne)
Vascular :
Hepatic Artery thrombosis
Portal vein thrombosis
Biliary :
Bile leak
Immunological :
Acute cellular rejection
Interventions :
Reexploration
Percutaneous drainage of collection |
First 2 weeks |
ICU Stay
Hospital Stay
90 Day mortality
Between patent vs thrombosed group
Sepsis specific mortality
90 day mortality |
90 days
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective randomized control trial in adult living donor liver transplant where right lobe graft is used. The anterior sectoral venous outflow is reconstructed to form the neo-middle hepatic vein (MHV). The reconstruction of the MHV can either be with the Portal Vein (PV) from the recipient explanted liver, allogenous veins or synthetic grafts. This trial iis to compare the outcomes of PTFE graft vs PV for the neo-MHV reconstruction in term of neo- MHV patency, early graft dysfunction, 90-day mortality and other parameters. |