| CTRI Number |
CTRI/2016/08/007186 [Registered on: 16/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
05/08/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the outcomes between two different liver grafts in recipients and donors after live donor liver transplantation |
|
Scientific Title of Study
|
Randomized controlled trial to assess early post operative outcomes of Extended Right lobe grafts {with Middle Hepatic vein} versus Modified right lobe grafts{Reconstruction of segment 5 and segment 8 Branches} in the Recipient following Live Donor Liver Transplantation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Christi Titus Varghese |
| Designation |
McH Resident |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Dept of GI surgery,
Amrita Institute Of Medical Sciences,
Ponekkara PO,
Kochi,Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9447798658 |
| Fax |
|
| Email |
christititus@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudhindran S |
| Designation |
Professor |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Professor,
Dept of GI Surgery, Vascular Surgery and Transplantation,
Amrita Institute Of Medical Sciences,
Ponekkara PO,
Kochi,Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9388623851 |
| Fax |
|
| Email |
sudhi@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Christi Titus Varghese |
| Designation |
McH Resident |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Dept of GI surgery,
Amrita Institute Of Medical Sciences,
Ponekkara PO,
Kochi,Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9447798658 |
| Fax |
|
| Email |
christititus@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christi Titus Varghese[Principal Investigator],
Dept Of GI Surgery,
Amrita Institute of Medical Sciences,
Ponekkara PO,
Kochi,Kerala |
|
|
Primary Sponsor
|
| Name |
Christi Titus Varghese |
| Address |
Dept of GI surgery,
Amrita Institute of Medical Sciences,
Ponekkara PO,
Kochi,Kerala |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Christi Titus Varghese |
Amrita Institute Of Medical Sciences |
Dept Of GI surgery,
Amrita Institute Of Medical Sciences,
Ponekkara PO,
Kochi,Kerala
Ernakulam
KERALA |
9447798658
christititus@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Thesis Protocol review Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
To study the early post operative outcomes in patients who undergoe live donor liver transplantation as per standard accepted criteria.Outcome in donors who undergoe the donor surgery is also studied, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extended Graft Group[Native middle hepatic vein] |
Patients are randomized to groups were either the middle hepatic vein is taken from the donor or not. |
| Comparator Agent |
Modified Graft group[were segment 5 and segment 8 veins are reconstructed in recipient] |
Patients are randomized to two groups based on whether middle hepatic vein is taken or not form the donor.If not taken it is reconstructed in the recipient |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
.Patients with liver disease who meet the criteria for live donor liver transplantation
.Live donor suitable for extended right hepatectomy[with middle hepatic vein]
a.Has a future liver remnant of more than 30%
b.Live donor with adequate segment 4a drainage to left hepatic vein[usually a umblical vein]
c.Steatosis less than 20% as assessed by L-S ratio on plain CT. |
|
| ExclusionCriteria |
| Details |
.Thrombosed recipient portal Vein.
.Graft to recipient wight ratio less than 0.7.
.Venous drainage of segment 4 mainly to middle hepatic vein in donor
.ABO incompatible liver transplants
.Donor at or above 55 years of age |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recipient:
Early Allograft Dysfuction[EAD]
Small for size Syndrome[SFSS]
Primary graft non function[PGNF}
Patency of Middle hepatic vein
Number of days in ICU
Mortality at the end of 90 days
Donor:
Post Hepatectomy liver failure[PHLF}
Post operative Clavien-Dindo score
Number of days in hospital after surgery
CT based volume regeneration at the end of 60 days |
All parameters uptil discharge/one month[which ever comes later] or as specified with the outcome.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in post surgery liver parameters in donor and recipient |
Untill discharge/ 1Month [whichever comes later] |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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)
|
15/07/2014 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized parallel group trial designed to assess the early post operative outcomes in donors and recipients who undergoe Live donor liver transplantation.Outcomes in extended graft[with native middle hepatic vein] is compared with modified graft[with neo middle hepatic vein].It is conducted at a single centre [Amrita instititue of Medical sciences,Kochi,Kerala].Primary outcomes assessed in the recipient are Early allograft dysfunctio,.Primary graft non function,Small for size syndrome,Number of days in ICU and mortality at the end of 90 days.Primary outcomes assessed in the donor are Post hepatectomy liver failure,Volume regeneration after 60 days,Clavien Dindo Grading of post surgery morbidity and number of days in ICU after surgery.Change in post surgery liver parameters are also analysed in donor and recipient. |