| CTRI Number |
CTRI/2026/03/105376 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized study comparing two Robotic Liver Donation Surgeries: With versus without preservation of a part of middle hepatic vein. |
|
Scientific Title of Study
|
Robotic right donor hepatectomy with versus without partial middle hepatic vein: A Randomized Study |
| Trial Acronym |
ROMAN trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Pal |
| Designation |
Mch Surgical gastroenterology Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
G- block , Gastrosurgery OPD, Amrita Hospital, Ponekkara, AIMS (P.O.), Kochi - 682041, Kerala, India.
Ernakulam KERALA 682041 India |
| Phone |
9168418878 |
| Fax |
|
| Email |
aishwaryapal88449@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aishwarya Pal |
| Designation |
Mch Surgical gastroenterology Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
G-block , Gastrosurgery OPD, Amrita Hospital, Ponekkara, AIMS (P.O.), Kochi - 682041, Kerala, India.
Ernakulam KERALA 682041 India |
| Phone |
9168418878 |
| Fax |
|
| Email |
aishwaryapal88449@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aishwarya Pal |
| Designation |
Mch Surgical gastroenterology Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
G-block, Gastrosurgery OPD, Amrita Hospital, Ponekkara, AIMS (P.O.), Kochi - 682041, Kerala, India.
Ernakulam KERALA 682041 India |
| Phone |
9168418878 |
| Fax |
|
| Email |
aishwaryapal88449@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Amrita Hospital, Ponekkara, AIMS (P.O.), Kochi - 682041, Kerala, India. |
| Type of Sponsor |
Private medical college |
|
|
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 Aishwarya Pal |
Amrita Institute of Medical Sciences |
G- block , Gastrosurgery OPD, Amrita Hospital, Ponekkara, AIMS (P.O.), Kochi - 682041, Kerala, India. Ernakulam KERALA |
9168418878
aishwaryapal88449@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Comittee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K742||Hepatic fibrosis with hepatic sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified right lobe grafts |
Usually practiced in our centre, partial MHV taken |
| Intervention |
Taking pure right lobe grafts |
Pure right lobe grafts may have more segmental veins as they are take early in transection at being of seg 5 vein |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All adult robotic donor hepatectomies at our centre. |
|
| ExclusionCriteria |
| Details |
A open donor hepatectomies performed during this study period will be excluded. These include
(a)emergency donor hepactectomies
(b)robotic slot not available or
(c)patient nor willing for robotic
(d)ABO incompatible grafts.
(e) Combined liver, pancreas, small bowel transplantation.
(f) Retransplantation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary To compare the patency of Neo Middle Hepatic Vein of right lobe grafts with and without partial MHV retrieved robotically in the recipient at 2 weeks, 8weeks.
|
2 weeks, 8weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Donor parameters
1.Transection time
2.Blood loss during the procedure.
3.Peak and mean lactate levels
4.Post operative liver function -Peak and mean levels of Serum Bilirubin, SGOT, SGPT, ALP,GGT&PTINR
5.Time taken for normalization of transaminases, INR
6.Post hepatectomy complications as per clavian dindo classification
7. Satava Classification
8.Graft steatosis using liver biopsy
9.Liver regeneration using plain CT volumetry done after 8 weeks.
10.Duration of ICU stay
11.Need for readmission |
2 weeks, 8weeks. |
Recipient parameters
1.Blood loss.
2.Peak and mean lactate levels
3.Post operative liver function -Peak and mean levels of Serum Bilirubin, SGOT, SGPT, ALP,GGT&PTINR
4.Peak transaminitis
5. Time taken for normalization of transaminases,INR
6. Early graft dysfunction
7.Clavien dindo classification for severity of surgical complication
8.Satava Classification
9.Small for size graft syndrome
10.Primary non function of the graft ( (PNF)
11.Duration of ICU stay
12.Liver regeneration using CT volumetry done after 8 weeks.
13.Need for readmission
14.Mortality.
|
2 weeks, 8weeks. |
During bench
1.Reconstructable veins during
bench more than 4mm
2.Cold ischemia time (CIT)
3.Warm ischemia time (WIT) |
2 weeks, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
16/03/2026 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In adults, live donor liver transplantation, right lobe from the donor is usually harvested for implantation. The aim of right lobe donation to transect the liver parenchyma in relation with middle hepatic vein in such a way that there is good venous outflow in both the remnant donor liver as well as the recipient graft. Usually it varies in how much middle hepatic vein is retrieved with the donor. It can either retrieved partially or not at all. In both the cases, for good venous outflow from the graft there is need for reconstruction of the tributaries draining in to the middle hepatic vein. In the grafts retrieved with partial middle hepatic vein reconstruction is easier and of shorter length while in those without middle heaptic vein it can be more difficult and sometimes can result in a longer graft. The patency of these grafts may vary but robust data regarding this is scarce.
Currently in our unit right lobe donation is harvested robotically. Whether harvesting middle hepatic vein partially or retrieving it without middle hepatic vein differ in terms of difficulties in robotic surgery practices is not known. The aim of this study is to compare the outcomes of robotic donor hepatectomies performed in two different ways, one with partial hepatic vein other without middle hepatic vein. As of now there is no such data available. |