| CTRI Number |
CTRI/2023/07/055268 [Registered on: 17/07/2023] Trial Registered Prospectively |
| Last Modified On: |
14/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Detection of tumors in the gall bladder using Ultrasound and Computed Tomography. |
|
Scientific Title of Study
|
Role of Ultasonography and Computed Tomography in gall bladder masses and their correlation with Cytopathology. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubham Sharma |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Room number 22, Department of Radiodiagnosis, Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh, India
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
6377984353 |
| Fax |
|
| Email |
dr.shubhamsharma19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushpakant Tiwary |
| Designation |
Professor and Head of Department of Radiodiagnosis |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Room no. 27, Department of Radiodiagnosis, Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh, India
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9044484353 |
| Fax |
|
| Email |
drshubhamdrpktiwariradiology@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Sharma |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh, India |
| Address |
Room number 22, Department of Radiodiagnosis, Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh, India
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
6377984353 |
| Fax |
|
| Email |
dr.shubhamsharma19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Sharma |
| Address |
Room no. 47, Boys Resident Hostel, Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh, India |
| Type of Sponsor |
Other [Self] |
|
|
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 SHUBHAM SHARMA |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL |
Room number 22, Department of Radiodiagnosis, Varun Arjun Medical College and Rohilkhand Hospital, Banthara, Shahjahanpur, Uttar Pradesh, India
Shahjahanpur
UTTAR PRADESH |
6377984353
dr.shubhamsharma19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VARUN ARJUN MEDICAL COLLEGE |
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 |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have undergone Ultrasonography (USG) and Contrast Enhanced Computed Tomography (CECT) abdomen followed by Cyto-pathological examination for GB mass lesions. |
|
| ExclusionCriteria |
| Details |
1. Patients coming with any of the three evaluating modality which are Ultrasonography, Computed Tomography and Fine Needle Aspiration Cytology done outside.
2. Patients under age of 20 and above 90 will be excluded. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gall bladder mass lesion. |
1 week, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlating gall bladder mass lesions with cyto-pathology. |
8 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/07/2023 |
| 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="6"
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
|
OBSERVATIONAL The prospective study of “ROLE OF ULTRASONOGRAPHY AND COMPUTED TOMOGRAPHY IN GALL BLADDER MASSES AND THEIR CORRELATION WITH CYTOPATHOLOGY†in all consecutive patients of different age groups between the age of 20 to 90 years old and either sex will be conducted with a suspected GB or biliary tract pathology or patients incidentally detected with GB wall thickening.
|