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CTRI Number  CTRI/2026/02/103842 [Registered on: 13/02/2026] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective Observational 
Study Design  Other 
Public Title of Study   Factors predicting intraoperative inoperability in radiologically resectable gallbladder malignancies 
Scientific Title of Study   Factors predicting intraoperative inoperability in radiologically resectable gallbladder malignancies 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Study Protocol Version 1.1 dated 18/12/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shraddha Padkar  
Designation  Professor and Surgeon  
Affiliation  Tata Memorial Hospital 
Address  OPD no 319, Department of Surgical Oncology, GI DMG OPD, 3rd Floor, Homi Bhabha Building, Tata Memorial Hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9820074818  
Fax    
Email  drshraddhapatkar@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Dhaval Vasa 
Designation  Assistant Professor and surgeon  
Affiliation  Tata Memorial Hospital 
Address  Dr Ernest Borges Marg parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9537454971  
Fax    
Email  dhavalsvasa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shraddha Padkar  
Designation  Professor and Surgeon  
Affiliation  Tata Memorial Hospital 
Address  OPD no 319, Department of Surgical Oncology, GI DMG OPD, 3rd Floor, Homi Bhabha Building, Tata Memorial Hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9820074818  
Fax    
Email  drshraddhapatkar@gmail.com   
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel , Mumbai, Maharashtra, India 400012  
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Dr E Borges Road, Parel, Mumbai, Maharashtra India 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 Shraddha Patkar   Tata Memorial Hospital   OPD no 319, GI Disease Managment OPD, 3rd Floor, Homi Bhabha Building, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA 		 9820074818

drshraddhapatkar@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Advance centre for treatment,research and education in cancer Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Any patient with GBC deemed inoperable on staging laparoscopy and exploratory laparotomy (for early GBC, locally advanced GBC and incidentally detected GBC - iGBC ) will be included in the inoperable group.
All patients operated for radical cholecystectomy for gallbladder malignancy (early GBC, locally advanced GBC and incidentally detected GBC) will be included in the operable group.
 
 
ExclusionCriteria 
Details  •Operated gallbladder patients for non-malignant causes
•Final histopathology for gallbladder does not show malignancy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate correlation of tumor markers as predictor of inoperability in early, locally advanced and incidentally detected GBC.
2.To evaluate presentation with obstructive jaundice as a predictor for inoperability in in early, locally advanced and incidentally detected GBC
 		 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To identify radiological predictors predicting inoperability in early, locally advanced and incidentally detected GBC.
2.To co-relate histology and differentiation with inoperability in GBC.
 		 6 Months 
 
Target Sample Size   Total Sample Size="333"
Sample Size from India="333" 
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)   09/03/2026 
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="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   Study Title:- Factors predicting intraoperative inoperability in radiologically resectable gallbladder malignancies

Type of Study:- Retrospective Observational Study 

Gallbladder cancer (GBC) is an aggressive malignancy in which surgical resection offers the best chance of long-term survival. Although preoperative evaluation using tumor markers, CT/PET-CECT and staging laparoscopy suggests resectability, a subset of patients (approximately 15–20%) are found to be inoperable during surgery. Inoperability may result from peritoneal disease, liver metastases, positive peritoneal cytology, inter-aortocaval lymph node involvement or extensive local tumor spread. Identifying preoperative and intraoperative predictive factors allows better patient selection, improves surgical decision-making and may reduce non-therapeutic laparotomies.
 
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