| CTRI Number |
CTRI/2026/01/100312 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
“A Worldwide Registry of Patients with Gall Bladder Cancer” |
|
Scientific Title of Study
|
Global Gall Bladder Cancer Registry to collate data on epidemiology, treatment patterns and outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Study Protocol Version 1.0 dated 21/07/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Goel |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dr Ernest Borges Marg parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820504492 |
| Fax |
|
| Email |
drmaheshgoel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shraddha Patkar |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dr Ernest Borges Marg parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820074818 |
| Fax |
|
| Email |
drshraddhapatkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Goel |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dr Ernest Borges Marg parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820504492 |
| Fax |
|
| Email |
drmaheshgoel@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Hepatopancreatobiliary Association in collaboration with Radboudumc.
Geert Grooteplein Zuid 10, 6525 GA Nijmegen P.O. Box 9101, 6500 HB Nijmegen, The Netherlands |
|
|
Primary Sponsor
|
| Name |
International Hepatopancreatobiliary Association in collaboration with Radboudumc |
| Address |
Geert Grooteplein Zuid 10, 6525 GA Nijmegen P.O. Box 9101, 6500 HB Nijmegen, The Netherlands |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Netherlands |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahesh Goel |
Tata Memorial Hospital |
Dr Ernest Borges Marg parel, Mumbai
Mumbai
MAHARASHTRA |
9820504492
drmaheshgoel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K828||Other specified diseases of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients with a diagnosis of gallbladder cancers |
|
| ExclusionCriteria |
| Details |
• Patients with other biliary tract cancers
• Patients found to have non-malignant pathology on final histopathology report
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Register prevalent cases within a defined time period (diagnosed from 1st Jan 2016 to 30th September 2025)
2.Collect demographic data
3.Collect surgical data and outcomes (where appropriate)
4.Collect non-surgical treatment data Describe clinical outcomes according to region, demographics and treatment
|
5 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL
|
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="2500"
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)
|
30/01/2026 |
| 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="5"
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
|
Aim:- To describe
prevalence and clinical outcomes of patients diagnosed with GBC
Gall bladder cancer (GBC) is an uncommon malignancy with marked geographic and ethnic variation in incidence and is associated with poor overall prognosis. While surgery remains the cornerstone of curative treatment, optimal management requires a multimodal, multidisciplinary approach tailored to disease stage, tumour biology, and patient-related factors. However, current evidence specific to GBC is limited, as it is frequently grouped with other biliary tract cancers, and treatment practices vary considerably across institutions and regions.
This multi-centric, observational global registry aims to systematically collect real-world data on the epidemiology, aetiology, staging, treatment patterns, and clinical outcomes of patients with GBC. The collated data will help identify variations in practice, assess outcomes across different treatment strategies, and generate robust evidence to inform future clinical guidelines, treatment algorithms, and national and international consensus statements for the management of gall bladder cancer. |