| CTRI Number |
CTRI/2025/08/093468 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational single centre study to devolep a pictorial tool to predict and avoid unnecessary Surgery in gallbladder Cancer. |
|
Scientific Title of Study
|
Development of a novel predictive nomogram to prevent futile surgery in gallbladder cancers a single center analysis of resected gallbladder cancers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project no 901168 version 1.0 dated 05.05.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shraddha Patkar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
OPD no 319, Department of Surgical Oncology, GI DMG, Homibhabha Building, 3rd Floor, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820074818 |
| Fax |
|
| Email |
drshraddhapatkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shraddha Patkar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
OPD no 319, Department of Surgical Oncology, GI DMG, Homibhabha Building, 3rd Floor, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820074818 |
| Fax |
|
| Email |
drshraddhapatkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shraddha Patkar |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
OPD no 319, Department of Surgical Oncology, GI DMG, Homibhabha Building, 3rd Floor, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820074818 |
| Fax |
|
| Email |
drshraddhapatkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, Dr E Borges Road Parel, Mumbai, Maharashtra, India 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital, Mumbai |
| Address |
Dr E Borges Road, Parel, Mumbai, Maharashtra, India 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gurudutt Varty |
Advanced Centre For Treatment Research & Education In Cancer |
OPD no 116, Shantisadan Building, GI DMG, Plot No. 1& 2, Sector 22
Kharghar, Navi Mumbai - 410210
Mumbai (Suburban)
MAHARASHTRA |
9766670376
gurudutt89@gmail.com |
| Dr Shradha Patkar |
Tata Memorial Hospital |
OPD no 319, Department of Surgical Oncology, GI DMG, Homibhabha Building, 3rd Floor, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA |
9820074818
drshraddhapatkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Advanced Centre For Treatment Research & Education In Cancer Institutional Ethics Committee |
Approved |
| Advanced Centre For Treatment Research & Education In Cancer Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients with histopathology proven gallbladder adenocarcinoma (GBAC)
2. All GBC patients who underwent a curative resection at Tata Memorial Hospital, Parel.
|
|
| ExclusionCriteria |
| Details |
1. Patients with other GBC pathologies such as neuroendocrine, sarcomatoid or hepatoid as well as benign pathologies.
2. Macroscopic positive (R2) resections or inoperable disease on surgical exploration
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to develop a nomogram to predict possibility of ‘futile surgery’ in gallbladder cancers |
12 months from the study start date |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess disease-free survival, defined as the time from surgery to recurrence or death, will be evaluated. |
12 months from the study start date |
| To assess the overall survival. |
12 months from the study start date |
|
|
Target Sample Size
|
Total Sample Size="1126"
Sample Size from India="1126"
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)
|
08/09/2025 |
| 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
|
Gallbladder cancer (GBC) has a higher rate of occurrence in India compared to the rest of the world. Surgery to remove the gallbladder is often seen as the only way to cure GBC. Surgery ranges from a simple removal of gallbladder to major liver surgery depending on different stages of GBC. However, even after surgery, many patients (20-30 percentage) only live for about five years, and over half see the cancer come back. This raises the question if surgery is the best option for all GBC cases. Sometimes, the risks of GBC surgery can be more than the benefits and it might not help the patient to live longer or feel better. This is called ‘futile surgery’. This study has gathered data of a large population of GBC patients to understand which patients are likely to not have any benefit from surgery. The goal of this study is to create a tool which will help doctors in identifying such patients. This will avoid unnecessary surgeries and focus on treatments which will be helpful to patients. |