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CTRI Number  CTRI/2025/05/086155 [Registered on: 02/05/2025] Trial Registered Prospectively
Last Modified On: 01/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to evaluate the correlation between the ultrasound risk detection scoring system for gall bladder with Lab test results from tissue samples in order to determine the diagnostic accuracy of scoring system in correclty detecting the cancer and benign conditions 
Scientific Title of Study   Correlation of GBRADS USG scoring system with histopathology 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 4698_version 2.0 dated 17/03/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shraddha Patkar 
Designation  Professor  
Affiliation  Tata Memorial Hospital 
Address  Room No 1209,Hepato-Billiary Surgery Division, Department ofSurgical Oncology, 12th Floor, Homi Bhabha building, Dr E Borges Road, Parel

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 
Address  Room No 1209,Hepato-Billiary Surgery Division, Department ofSurgical Oncology, 12th Floor, Homi Bhabha building, Dr E Borges Road, Parel


MAHARASHTRA
400012
India 
Phone  9820074818  
Fax    
Email  drshraddhapatkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sathyanathan M M 
Designation  Surgical Resident 
Affiliation  Tata Memorial Hospital 
Address  OPD No 319, Gatro-Intestinal Disease Management Group, Dept of Surgical Oncology, 3rd Floor, Homi Bhabha building, Dr E Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9080353787  
Fax    
Email  silambusathya333@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-12 
 
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, Surgical oncology OPD-GI DMG, 3rd floor, Homi Bhabha Building,Parel, Mumbai
Mumbai
MAHARASHTRA 
9820074818

drshraddhapatkar@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: K829||Disease of gallbladder, unspecified, (2) 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  Inclusion: Any patients with suspected gallbladder pathology who have undergone ultrasound imaging followed by histopathological examination (either a biopsy or a surgery) 
 
ExclusionCriteria 
Details  All patients with metastatic disease at presentation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Accuracy of GBRADS in predicting the final histopathology findings.  After completion of data collection- 1yr  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   16/05/2025 
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  

India has one the highest incidences of Gallbladder Cancer (GBC) in the world, as per registry and GLOBOCAN data. Advanced GBC has a poor prognosis hence early diagnosis and management are crucial. Ultrasound/ Sonography is often the first imaging test to evaluate patients with suspected gallbladder diseases. Gallbladder wall thickening (GWT) is a common finding at ultrasound. It is nonspecific and represents both benign and malignant diseases.

The importance of wall thickening as a sign of gallbladder cancer is often missed during preoperative evaluations. This can lead to finding gallbladder cancer by chance or, worse, to more advanced disease and poorer outcomes. This study looks at past data to find out how well the GB-RADS scoring system works in identifying whether gallbladder conditions are malignant or benign.

The Gall Bladder Reporting and Data System (GBRADS) is ultrasound risk stratification reporting tool proposed to improve consistency in ultrasound interpretations, reporting and assessment of risk of malignancy in gallbladder wall thickening.

In this study we will evaluate the correlation between the GBRADS ultrasound scoring system and histopathological findings in order to determine the accuracy of GBRADS scores in predicting malignancy and benign conditions of gall bladder.

In this study we will enroll any patients with suspected gallbladder pathology who have undergone ultrasound imaging followed by histopathological examination (either a biopsy or a surgery) only patients with metastatic disease at presentation will be excluded.

A total pf 150 participants will be collected in this study. This is a retrospective study only data collection will be done. In this study patients underwent ultrasound and scored via GBRADS for any suspected gall bladder pathology and histopathological examination from 1st of February 2023 will be enrolled into the study.

 
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