| 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
|
|
|
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
|
|
|
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. |