FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094078 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 01/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study on patients undergoing liver surgery to check how well the liver is working before surgery and to predict chances of liver problems after surgery and also to devolep a pictorial chart which will help in predication of liver failure. 
Scientific Title of Study   Preoperative risk assessment for post-hepatectomy liver failure (PHLF) by FLR, ICG and indocycanine green and development of a model predicting PHLF using all three modalities. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 4760 V 2.0, dated 10.06.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh Goel 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Surgical Oncology, GI disease management group, 3rd floor, Homi Bhabha Building, Dr E Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9820504492  
Fax    
Email  drmaheshgoel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh Goel 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Surgical Oncology, GI disease management group, 3rd floor, Homi Bhabha Building, Dr E Borges Road, Parel


MAHARASHTRA
400012
India 
Phone  9820504492  
Fax    
Email  drmaheshgoel@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR TAHER ALI KOTWALA 
Designation  Surgical Resident  
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Surgical Oncology, GI disease management group, 3rd floor, Homi Bhabha Building, Dr E Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  7869844743  
Fax    
Email  taheralikotwala@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai, Maharashtra 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E Borges Road, Parel, Mumbai, Maharashtra 400012 
Type of Sponsor  Research institution and hospital 
 
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 TAHER ALI KOTWALA  Tata Memorial Hospital  OPD no 324, Department of Surgical oncology, GI Disease management Group, 3rd Floor, Homibhabha Building, Dr E Borges Road, Parel,
Mumbai
MAHARASHTRA 		 7869844743

taheralikotwala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C228||Malignant neoplasm of liver, primary, unspecified as to type, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.All patients over 18 years of age, planned for major hepatectomies
2.Patient planned for minor hepatectomies, but ICG and Fibroscan deemed necessary after multi-disciplinary discussion in view of cirrhosis.
 
 
ExclusionCriteria 
Details  1. Minor Hepatectomies (except the above)
2.Patient who refused to give valid consent for the study
3.Patients who are unfit for surgery due to medical comorbidities
4.Patients with Obstructive Jaundice (ICG clearance impaired)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To investigate the effectiveness of combination of FLR, ALBI score, APRI score, ICG and Fibroscan in predicting incidence of PHLF, Severity of PHLF and peri-operative mortality in Posthepatectomy liver failure
 		 till hospital stay after surgery and day 30, day 60 post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Risk of Hepatic decompensation later  beyond 3 months after surgery 
disease Recurrences, Overall survival, and Disease free survival after hepatectomy
 		 day 30, day 60 and then every 6 monthly 
To develop a predictive model for PHLF using the modalities.  day 30, day 60 and then every 6 monthly 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/09/2025 
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   This study aims to improve how doctors predict the risk of post-hepatectomy liver failure (PHLF), a serious complication that can occur after liver surgery. While liver surgery has become much safer over the years, some patients still experience complications, including liver failure, which can be life-threatening. Currently, doctors use various methods to assess liver function before surgery, but no single approach is entirely reliable. 

This study focuses on combining three key preoperative tests—Future Liver Remnant (FLR) measurement, Fibroscan (a non-invasive liver stiffness test), and the Indocyanine Green (ICG) clearance test, ALBI (Albumin-bilirubin) score and APRI (Aspartate transaminase- Platelet Index) score —to develop a better way to predict PHLF and improve patient outcomes. 

 The study will involve 100 patients (50 as prospective and 50 as retrospective) undergoing liver surgery at the hospital. Before surgery, each patient will undergo FLR calculation using imaging techniques, a Fibroscan to assess liver stiffness, and an ICG test, which measures how well the liver processes a special dye and ALBI and APRI score calculation. 

These results will then be analyzed and compared with actual surgical outcomes to determine how effectively these tests can predict PHLF. The goal is to see whether combining these methods provides a more accurate prediction than using just one or two, ultimately helping surgeons make better decisions before surgery. Since this is an observational study, no experimental treatments will be introduced. Patients will undergo their planned liver surgery with the usual preoperative assessments, and the study will simply analyze the data collected to improve future patient care. Researchers expect to find that using all three tests together will provide a clearer and more accurate picture of liver function, allowing doctors to identify high-risk patients more reliably. 

This could lead to better decision-making, potentially reducing complications and improving survival rates. Patients participating in the study will provide informed consent, and all personal information will be kept strictly confidential. Any serious complications that arise will be reported immediately and handled according to hospital safety guidelines. The ultimate aim is to develop a reliable risk prediction model using these three preoperative tests, which could become a valuable tool for surgeons in planning safer liver surgeries and improving patient outcomes.
 
Close