| CTRI Number |
CTRI/2025/02/080550 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare the performance of different techniques of endoscopic ultrasound guided fine needle biopsy of pancreatico biliary lesions |
|
Scientific Title of Study
|
To compare the diagnostic performance of different suction techniques during EUS - FNB for pancreatico-biliary lesions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Agarwal |
| Designation |
Associate professor, Department of Gastroenterology |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 114,Department of Gastroenterology,
1st floor, Block A
OPD block
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
|
| Fax |
|
| Email |
drashu123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Terence Susngi |
| Designation |
Senior Resident, Department of Gastroenterology |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 115, Department of Gastroenterology,
1st floor, Block A
OPD block
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9789320051 |
| Fax |
|
| Email |
tcsusngi1705@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Terence Susngi |
| Designation |
Senior Resident, Department of Gastroenterology |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 115, Department of Gastroenterology
1st floor, Block A
OPD block
AIIMS Jodhpur
RAJASTHAN
342001
India |
| Phone |
9789320051 |
| Fax |
|
| Email |
tcsusngi1705@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Basni, Jodhpur
Pin - 342005
Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Room no 115,
1st floor, Block A,
OPD block,
AIIMS Jodhpur
Rajasthan-342001 |
| Type of Sponsor |
Government medical college |
|
|
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 Terence Susngi |
AIIMS, Jodhpur |
Department of Gastroenterology, Room 115, 1st floor, A block, OPD block
Jodhpur
RAJASTHAN |
9789320051
tcsusngi1705@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endoscopic ultrasound guided Fine needle biopsy- No suction technique |
The biopsy needle will be flushed with 5 ml normal saline, if previous biopsy was already taken. The lesion is localised with Endoscopic ultrasound. The 22G needle is introduced into the biopsy channel no suction needle is attached to the needle. After ruling out significant doppler signal in the needle path, needle puncture will be made into the lesion and multiple passes will be made. The biopsy obtained is released into the formalin containing sample container and sent for histopathological analysis |
| Intervention |
Endoscopic ultrasound guided Fine needle biopsy- Slow stylet pull technique |
The biopsy needle will be flushed with 5 ml normal saline, if previous biopsy was already taken. The lesion is localised with Endoscopic ultrasound. The 22G needle is introduced into the biopsy channel with full insertion of stylet. After ruling out significant doppler signal in the needle path, needle puncture will be made into the lesion and multiple passes will be taken as the stylet is removed slowly from the needle and the biopsy obtained, is released into the formalin containing sample container. |
| Intervention |
Endoscopic ultrasound guided Fine needle biopsy- Wet suction technique |
The biopsy needle will be flushed with 5 ml normal saline, if previous biopsy was already taken. The lesion is localised with Endoscopic ultrasound. The 22 G needle is introduced into the biopsy channel and stylet is removed. A syringe containing 9 ml saline and 1 ml heparin with pre applied negative suction force, is attached to the end of the needle to provide continous negative presure suction. After ruling out significant doppler signal in the needle path, needle will puncture the lesion and multiple passes will be taken and biopsy is obtained into the formalin containing sample container. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years
2. patients with pancreatic, peripancreatic and pancreaticobiliary solid lesions which requires EUS- FNB for diagnosis
3. Informed consent is obtained |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years
2. Active gastrointestinal bleeding
Bleeding tendency (platelet less than 50,000/mm3 and/or PT INR more than 1.5)
3. Pregnant patient
4. Unable to understand and/or read the informed consent.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy in diagnosing the lesions, compared with final diagnosis. Final diagnosis confirmed by three methods: the results of EUS-FNB, surgical pathology, if available, and clinical follow-up for at least 3 months |
At 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Sensitivity of each technique
2.Specificity of each technique
3.Positive predictive value of each technique
4.Negative predictive value of each technique
5.Specimen quality of each technique as defined by the following:
a. Tissue integrity
b. Blood contamination
c. Cellularity
6.Technical success rate of each technique
7.Rate of adverse events of each technique
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/02/2025 |
| 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="2"
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
|
EUS FNB is now being considered the optimal technique for sampling of pancreaticobiliary lesions due to its high accuracy and less adverse complication rates. Currently, to the best of our knowledge, there is no data in India regarding the optimal sampling technique. This is a prospective, randomized controlled trail, with three arms, comparing the diagnostic efficacy of EUS FNB techniques – standard no suction vs stylet slow pull vs wet suction for pancreaticobilary lesion. We aim to include all patients more than 18 years presenting to us with indication of for EUS FNB for pancreaticobilary lesions and giving informed consent, excluding age morethan18, bleeding diathesis and pregnant women. We shall compare the three techniques by taking a biopsy consecutively with each sampling technique, and send each separately labelled sample to the pathologist, who is blinded to the technique of sampling and will report each sample individually and the results will be analysed according to the accuracy provided by the sampling technique and the final diagnosis, along with the tissue integrity and blood contamination. Further treatment will be as per treating physician. Expected outcome will be to compare the non inferiority of wet suction and slow stylet pull technique with the standard no suction technique. |