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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
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