RCT: Difference in Diagnostic Yield Between EUSFNA Needles With and Without a Side Port in Pancreatic Masses

NCT02092519 | Completed Phase 4 DMC

• 1 other identifier: ATL2012/312/E
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 Preliminary unpublished retrospective data suggested the yield might be raised.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

Pancreatic Neoplasm; Pancreatic Diseases

Keywords

EUSFNA; endoscopic ultrasound; pancreatic masses

Outcome Measures

Primary Outcomes (1)

• diagnostic accuracy

  Compare the overall diagnostic accuracy rate between both needles

  within 1 month after EUSFNA and cytological assessment

Study Arms (2)

Needle without sideport (NA-220H-8022)

ACTIVE COMPARATOR

EUSFNA using needle without sideport (NA-220H-8022)

Device: Needle with sideport (NA-230H-8020)

Needle with sideport (NA-230H-8020)

ACTIVE COMPARATOR

EUSFNA using needle with sideport (NA-230H-8020)

Device: Needle without sideport (NA-220H-8022)

Interventions

Needle with sideport (NA-230H-8020) DEVICE

EUSFNA using needle with sideport

Needle without sideport (NA-220H-8022)

Needle without sideport (NA-220H-8022) DEVICE

EUSFNA using needle without sideport

Needle with sideport (NA-230H-8020)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients referred for EUSFNA of pancreatic masses
• informed consent is obtained for performance of EUSFNA.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changi General Hospital: lead
• Asan Medical Center: collaborator
• National Taiwan University Hospital: collaborator

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

Related Publications (3)

• Polkowski 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 BACKGROUND

• Dumonceau 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 BACKGROUND

• Ang 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 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Diseases

Interventions

Needles

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Tiing Leong Ang, MD

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: March 20, 2014
• Study Start: April 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

SG (1)