| CTRI Number |
CTRI/2024/10/075450 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of the 2 EUS guided tissue acquisition methods in better diagnosis of solid lesions (gastro-intestinal, pancreatic, biliary system and lymph nodes). |
|
Scientific Title of Study
|
Comparative study of diagnostic performance of advanced imaging techniques versus Standard B-mode for Endoscopic Ultrasound guided tissue acquisition-An Analytical cross-sectional study. |
| 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 Nikhil Sonthalia |
| Designation |
Senior Consultant and Associate Professor |
| Affiliation |
Institute of Gastrosciences, Apollo Multispecialty Hospital |
| Address |
Day care building, 4th Floor, Room No.5,
Apollo Multispecialty Hospitals, Kolkata, 58 , Canal Circular Road,
Kolkata
WEST BENGAL
700054
India |
| Phone |
9004203165 |
| Fax |
|
| Email |
nikhil_zenith@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tulika Gupta |
| Designation |
DrNB Gastrenterology resident |
| Affiliation |
Institute of Gastrosciences, Apollo Multispecialty Hospital |
| Address |
Day care building, 4th Floor, Room No.5,
Apollo Multispecialty Hospitals, Kolkata, 58 , Canal Circular Road,
Kolkata
WEST BENGAL
700054
India |
| Phone |
9326093725 |
| Fax |
|
| Email |
guptatulika19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Sonthalia |
| Designation |
Senior Consultant and Associate Professor |
| Affiliation |
Institute of Gastrosciences, Apollo Multispecialty Hospital |
| Address |
Day care building, 4th Floor, Room No.5,
Apollo Multispecialty Hospitals, Kolkata, 58 , Canal Circular Road,
Kolkata
WEST BENGAL
700054
India |
| Phone |
9004203165 |
| Fax |
|
| Email |
nikhil_zenith@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Institute of Gastro Sciences and Liver Transplantation, Apollo Multispeciality Hospitals, Kolkata, India, 700054 |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Indonesia |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikhil Sonthalia |
Institute of Gastrosciences & Liver Transplantation,Apollo Mutispeciaity Hospital, Kolkata |
Gastroenterology department, room no.5,
58 Canal circular road,Kolkata,700054, WB, India
Kolkata
WEST BENGAL |
9004203165
nikhil_zenith@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Apollo Multispeciality Hospitals Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K869||Disease of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Contrast enhanced Endoscopic Ultrasound and Elastography guided Endoscopic Ultrasound |
Patient undergoes EUS-guided tissue acquisition. Help of Contrast enhancement (will be studied for 90 seconds) and Elastography (will be studied for 30-60 seconds) will be taken to guide the area to be sampled. In Elastography, Strain ratio and Strain Histogram will be documented. In Contrast, pattern of enhancement will be documented. Total duration of 1 pass varies between 5-10 minutes. |
| Comparator Agent |
In standard arm, B-mode EUS will be used for tissue sampling, without the aid of image enhancement |
Under Standard B-mode EUS (lesion will be assessed for 90 seconds), avascular path will be identified and tissue sampling will be done in routine way, without image enhancement. Total duration of 1 pass varies between 5-10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. All adult patients undergoing EUS-guided tissue acquisition (using FNB) for solid lesions (gastro-intestinal, pancreatic, biliary system and lymph nodes).
2. Able to comply with the study procedure and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years
2. Pregnancy
3. Presence of active bleed
4. Presence of coagulopathy, as evidenced by INR>1.5 and platelets <50,000
5. Patients on anti-coagulants or anti-platelets (eg- Clopidogrel).
6. Inability to sample because of intervening blood vessels seen during imaging or EUS (No suitable window found)
7. Poor patient tolerance to the procedure
8. Patients not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison between advanced imaging-techniques versus Standard B-mode for endoscopic ultrasound guided tissue acquisition in terms of Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), Diagnostic Accuracy (DA), and Diagnostic yield (DY). |
Baseline - At the time of EUS- guided tissue sampling
EUS-guided tissue Diagnosis - Day 4 of the procedure (when histopathology report is available)
In case of negative diagnosis of malignancy - 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Find out the elastography pattern of solid lesions undergoing EUS-guided tissue acquisition.
2. Find out the contrast enhancement pattern of solid lesions undergoing EUS-guided tissue acquisition. |
Baseline - At the time of EUS- guided tissue sampling
EUS-guided tissue Diagnosis - Day 4 of the procedure (when histopathology report is available) |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
29/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/10/2024 |
| 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 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
|
The current study aims to compare
the diagnostic performance of advanced
imaging-techniques versus Standard B-mode for endoscopic ultrasound guided
tissue acquisition, in a time-framed analytical comparative cross-sectional, single-center
study.
|