Clinical trial · Interventional
RCT: Difference in Diagnostic Yield Between EUSFNA Needles With and Without a Side Port in Pancreatic Masses
A Prospective Multi-center Randomized Study of the Difference in Diagnostic Yield Between EUSFNA Needles With and Without a Side Port in Pancreatic Masses
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: EUS-guided fine needle aspiration (EUSFNA) is a well established technique for tissue acquisition and diagnosis with excellent safety profile. The overall diagnostic yield of EUSFNA exceeds 80%, with higher rates in EUSFNA of lymph nodes, where rates of \>90% may be expected, as compared to pancreatic masses, where lower diagnostic rates were reported. To maximize the diagnostic yield, at least 3 needle passes are required for lymph nodes and at least 4 passes for pancreatic masses. Olympus has recently made commercially available a new 22 gauge FNA needle (EZ Shot 2 with side port) with a side port at the needle tip. The theoretical basis for introduction of the side port is to increase the diagnostic yield. Preliminary unpublished retrospective data suggested the yield might be raised. However, there are no prospective multicenter randomized controlled studies to ascertain the validity of the assumption. Aim: To determine whether there is a difference in diagnostic yield between EZ-Shot 2 and EZ-Shot 2 with side port in patients with pancreatic masses for evaluation. Methods: Patients with pancreatic masses referred for EUSFNA will be recruited prospectively and randomized to either EZ-Shot 2 or EZ Shot 2 with sideport for the first puncture, and then the alternative needle will be used for repeated punctured. The cytological and diagnostic yield at first pass for both needles will be compared. Clinical significance: This will determine whether the new needle design can further improve the diagnostic yield of EUSFNA of pancreatic masses.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Diseases | — | UNRESOLVED | — |
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Needle without sideport (NA-220H-8022) | Device | — | UNRESOLVED |
| Needle with sideport (NA-230H-8020) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Needle without sideport (NA-220H-8022)
- description
- EUSFNA using needle without sideport (NA-220H-8022)
- interventionNames
- Device: Needle with sideport (NA-230H-8020)
- type
- ACTIVE_COMPARATOR
- label
- Needle with sideport (NA-230H-8020)
- description
- EUSFNA using needle with sideport (NA-230H-8020)
- interventionNames
- Device: Needle without sideport (NA-220H-8022)
Primary outcomes (1)
- measure
- diagnostic accuracy
- timeFrame
- within 1 month after EUSFNA and cytological assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion criteria: * all patients referred for EUSFNA of pancreatic masses * informed consent is obtained for performance of EUSFNA. Exclusion criteria: * presence of active gastrointestinal bleeding * presence of coagulopathy as defined by platelet count \<50000/mm3 or/ and international normalized ratio \>1.5 * the current use of thienopyridines (e. g. clopidogrel) in patents requiring antiplatelet therapy8 * absence of procedural informed consent.
References
Publications (3)
- BACKGROUNDPolkowski M, Larghi A, Weynand B, Boustiere C, Giovannini M, Pujol B, Dumonceau JM; European Society of Gastrointestinal Endoscopy (ESGE). Learning, techniques, and complications of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline. Endoscopy. 2012 Feb;44(2):190-206. doi: 10.1055/s-0031-1291543. Epub 2011 Dec 16. PMID 22180307
- BACKGROUNDDumonceau JM, Polkowski M, Larghi A, Vilmann P, Giovannini M, Frossard JL, Heresbach D, Pujol B, Fernandez-Esparrach G, Vazquez-Sequeiros E, Gines A; European Society of Gastrointestinal Endoscopy. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2011 Oct;43(10):897-912. doi: 10.1055/s-0030-1256754. Epub 2011 Aug 12. PMID 21842456
- DERIVEDAng TL, Kwek AB, Seo DW, Paik WH, Cheng TY, Wang HP, Lau J. A prospective randomized study of the difference in diagnostic yield between endoscopic ultrasound-guided fine-needle aspiration (EUSFNA) needles with and without a side port in pancreatic masses. Endosc Int Open. 2015 Aug;3(4):E329-33. doi: 10.1055/s-0034-1391964. Epub 2015 May 26. PMID 26356802