| CTRI Number |
CTRI/2024/07/071142 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study will compare two needles to see which is one gives more tissue for better diagnosis while performing endoscopic ultrasound guided biopsy of lesions in the gastrointestinal wall. |
|
Scientific Title of Study
|
Comparison of Franseen versus Reverse bevel needle for endoscopic ultrasound guided fine needle biopsy of subepithelial lesions: a randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayanta Samanta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) |
| Address |
Department of Gastroenterology, Room 20, F-Block, Level 1, Postgraduate Institute of Medical Education and Research, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855319529 |
| Fax |
|
| Email |
dj_samanta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayanta Samanta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) |
| Address |
Department of Gastroenterology, Room 20, F-Block, Level 1, Postgraduate Institute of Medical Education and Research, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855319529 |
| Fax |
|
| Email |
dj_samanta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jayanta Samanta |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) |
| Address |
Department of Gastroenterology, Room 20, F-Block, Level 1, Postgraduate Institute of Medical Education and Research, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855319529 |
| Fax |
|
| Email |
dj_samanta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Gastroenterology,
Postgraduate Institute of Medical education and Research, Chandigarh
Sector - 12,
Chandigarh - 160012 |
|
|
Primary Sponsor
|
| Name |
Jayanta Samanta |
| Address |
Department of Gastroenterology, Room 20, Level 1, F-Block,
Postgraduate Institute of Medical Education and Research, Chandigarh
Sector - 12
Chandigarh - 160012
India |
| 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 Jayanta Samanta |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Department of Gastroenterology, Room 20
Nehru Hospital, Block F
Postgraduate Institute of Medical Education and Research, Chandigarh
Sector -12,
Chandigarh - 160012
India
Chandigarh
CHANDIGARH |
9855319529
dj_samanta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ehics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EUS FNB using franseen needle |
1. First an Endoscopic ultrasound will be performed using a curvilinear array echoendoscope and localize and characterize the lesion.
2. Biopsy with Franseen needle will be performed using a 22-gauge device.
3. At least 3 needle passes will be made into the target lesion before sending the specimen for formal histological analysis. Rapid on-site cytological evaluation (ROSE) will not be utilized.
4. FNB will be performed using the “slow-pull†technique for all 3 passes.
5. After each single pass, macroscopic on-site evaluation (MOSE) of the collected sample will be performed by the endosonographer and further passes will be performed if needed. The specimen will be deemed inadequate after 3 passes.
6. Specimens will be collected in 3 vials to allow for analysis according to needle pass; one for the first pass, one for the second pass, and one for the third and any eventual subsequent passes.
7. Cytopathologists and cytotechnicians will be blinded to the needle used.
8. Specimens categorized as “diagnostic†or “suspicious†will be both considered diagnostic for this study. |
| Comparator Agent |
EUS FNB using reverse bevel needle |
1. First an Endoscopic ultrasound will be performed using a curvilinear array echoendoscope and localize and characterize the lesion.
2. Biopsy with reverse bevel needle will be performed using a 22-gauge device.
3. At least 3 needle passes will be made into the target lesion before sending the specimen for formal histological analysis. Rapid on-site cytological evaluation (ROSE) will not be utilized.
4. FNB will be performed using the “slow-pull†technique for all 3 passes.
5. After each single pass, macroscopic on-site evaluation (MOSE) of the collected sample will be performed by the endosonographer and further passes will be performed if needed. The specimen will be deemed inadequate after 3 passes.
6. Specimens will be collected in 3 vials to allow for analysis according to needle pass; one for the first pass, one for the second pass, and one for the third and any eventual subsequent passes.
7. Cytopathologists and cytotechnicians will be blinded to the needle used.
8. Specimens categorized as “diagnostic†or “suspicious†will be both considered diagnostic for this study.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥18 years
2. Patients referred to endoscopic ultrasound with tissue sampling of SELs of the oesophagus, stomach, duodenum or rectum.
3. Agree to receive follow up phone calls
4. Able to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Coagulopathy or thrombocytopenia
2. Lack of consent
3. Pregnancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sample adequacy |
day 14 after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Diagnostic accuracy
2. Histological quality of the sample
3. Yield of the first needle pass
4. Number of needle passes
5. Adverse events
|
Day 14 after the procedure |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="1"
Days="1" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dj_samanta@yahoo.co.in].
- For how long will this data be available start date provided 01-12-2026 and end date provided 31-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Currently, endoscopic ultrasound (EUS) is considered a standard
diagnostic tool for characterization of subepithelial lesions owing to its
ability to determine the layer of origin, provide accurate measurements of
lesion size, and enable tissue acquisition for diagnosis. However, tissue
sampling through EUS-guided fine-needle aspiration (FNA) proved to be
significantly inferior in this setting as compared to bite-on-bite biopsy or
other mucosal incision assisted biopsy (MIAB) techniques. EUS-guided fine-needle biopsy (EUS-FNB), which typically uses a core
biopsy needle and preserves the cellular architecture, has become an
increasingly useful tool in the diagnostic algorithm of other abdominal
lesions, such as pancreatic masses. A recent meta-analysis showed that EUS-FNB clearly outperformed EUS-FNA
for tissue sampling of SELs, thus postulating a fundamental role of FNB in the
diagnostic algorithm of these lesions. However, a direct comparison between different EUS-FNB devices for
tissue sampling of SEL is still lacking. Hence, this study has been designed as a randomized
controlled trial (RCT) comparing two different EUS-FNB needles, Franseen tip
design versus reverse bevel tip design, for diagnosis of subepithelial lesions. |