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CTRI Number  CTRI/2025/11/097087 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 07/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   an observational study to find out why liver cancer returns after surgery, and the different ways it comes back, in patients in India who have had liver cancer removed. 
Scientific Title of Study   Post-hepatectomy Early Recurrences in Hepatocellular Carcinoma: Patterns and Treatment Approvaches in the Indian Subcontinent 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 4834 V2.0 Dated 14.08.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh Goel 
Designation  Professor and Cheif Hepato Billiary Surgeon 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Dept of Surgical Oncology, Gastrointestinal 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 and Cheif Hepato Billiary Surgeon 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Dept of Surgical Oncology, Gastrointestinal 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
Public Query
 
Name  Dr Mizelle DSilva 
Designation  Senior Resident 
Affiliation  Tata Memorial Hospital 
Address  OPD no 324, Dept of Surgical Oncology, Gastrointestinal Disease Management Group, 3rd Floor, Homi Bhabha Building, Dr E Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9820407293  
Fax    
Email  drmizelledsilva@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 Mizelle DSilva  Tata Memorial Hospital  OPD No 324, Dept of Surgical Oncology, GI DMG, 3rd Floor, Homi Bhabah Building, Dr E Borges Road, Parel, Mumbai-12
Mumbai
MAHARASHTRA 
9820407293

drmizelledsilva@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee-i  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C220||Liver cell carcinoma,  
 
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  All patients who underwent curative resection for hepatocellular carcinoma 
 
ExclusionCriteria 
Details  Patients who underwent exploratory Laparotomy and were deemed unresectable 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
recurrences and factors affecting early recurrences in HCC  post surgery every 3 months for the first 2 years, every 6 months for the next 3 years and yearly thereafter 
 
Secondary Outcome  
Outcome  TimePoints 
patterns of recurrences and treatment options for these recurrences.  post surgery every 3 months for the first 2 years, every 6 months for the next 3 years and yearly thereafter 
 
Target Sample Size   Total Sample Size="336"
Sample Size from India="336" 
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)   24/11/2025 
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 Applicable 
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  

Recurrences after resection for HCC pose a significant treatment challenge. Early recurrences are defined as recurrences occurring within one year of surgery. They are the “true” recurrences - secondary to the presence of occult intrahepatic metastases and due to intrahepatic dissemination of neoplasm through the portal circulation. Late recurrence is related to underlying liver disease. Treatment of recurrence with various modalities tends to improve survival and must be individualized in a multidisciplinary tumor board. Over the years, various factors have been identified to predict early recurrences. However, studies from India in this regard are limited. Treatment options for recurrences in the Indian subcontinent may vary due to late presentation of patients, inadequate funds, patients’ poor nutritional and socio- economic status. This is a retrospective study of patients with HCC who have undergone surgical resection between July 2010 to July 2024. The study aims to analyze recurrence patterns after surgical resection for HCC and identify factors leading to early recurrence and discuss ways of managing these recurrences to improve outcomes.

 
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