| 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
|
|
|
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
|
|
|
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. |