Comparing Biopsy Needles for Endoscopic Ultrasound Guided Samples for Pancreatic Masses

NCT02911974 | Completed DMC

• 1 other identifier: 889569
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized prospective clinical study comparing a fine needle biopsy device and an aspiration needle.

Conditions

Pancreatic Neoplasm

Keywords

fine needle biopsy; EUS; solid pancreatic mass

Outcome Measures

Primary Outcomes (1)

• The total area of procured tissue between the FNA and FNB needles

  The primary objective of this study is to compare the total area of procured tissue between the FNA and FNB needles in patients undergoing EUS-guided sampling of pancreatic masses. Pancreatic masses sampled using the FNB needle should have a tissue area greater than the FNA needle because of the serrated design of the FNB needle tip. This will be measured using a specialized digital image analysis software. This hypothesis will be tested by comparing the total tissue area, tumor area within the tissue, stroma area within the tissue, tumor vs. stroma ratio and the macroscopic length of the procured tissue measured in millimeters. The total of these measurements will provide information about the area of procured tissue.

  6 months.

Secondary Outcomes (1)

• Diagnostic adequacy between the FNA and FNB needles

  6 months

Study Arms (2)

Acquire EUS Biopsy Device

ACTIVE COMPARATOR

All patients will undergo sampling of pancreatic masses using the Acquire EUS Biopsy Device. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types.

Device: Acquire EUS Biopsy Device

Expect EUS Aspiration Needle

ACTIVE COMPARATOR

All patients will undergo sampling of pancreatic masses using the Expect EUS Aspiration Needle. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types

Device: Expect EUS Aspiration Needle

Interventions

Acquire EUS Biopsy Device DEVICE

1\. At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or Expect EUS Aspiration Needle.

Acquire EUS Biopsy Device

Expect EUS Aspiration Needle DEVICE

1\. At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or Expect EUS Aspiration Needle.

Expect EUS Aspiration Needle

Eligibility Criteria

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

You may qualify if:

• Scheduled to undergo EUS
• Patients with solid pancreatic masses on cross-sectional imaging or with jaundice secondary to biliary obstruction
• Able and willing to provide written or verbal consent

You may not qualify if:

• Unable to safely undergo EUS for any reason
• Coagulopathy (Prothrombin time \> 18 secs, platelet count \< 80,000/ml)
• Active alcohol or other drug use or significant psychiatric illness
• Pregnancy
• Unable or unwilling to provide consent

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Center for Interventional Endoscopy - Florida Hospital

Orlando, Florida, 32803, United States

Location

Related Publications (5)

• Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.

  PMID: 22248600 BACKGROUND

• Varadarajulu S, Fraig M, Schmulewitz N, Roberts S, Wildi S, Hawes RH, Hoffman BJ, Wallace MB. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy. 2004 May;36(5):397-401. doi: 10.1055/s-2004-814316.

  PMID: 15100946 BACKGROUND

• Bang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy. 2016 Apr;48(4):339-49. doi: 10.1055/s-0034-1393354. Epub 2015 Nov 12.

  PMID: 26561917 BACKGROUND

• Ngamruengphong S, Li F, Zhou Y, Chak A, Cooper GS, Das A. EUS and survival in patients with pancreatic cancer: a population-based study. Gastrointest Endosc. 2010 Jul;72(1):78-83, 83.e1-2. doi: 10.1016/j.gie.2010.01.072.

  PMID: 20620274 RESULT

• Othman MO, Wallace MB. The role of endoscopic ultrasonography in the diagnosis and management of pancreatic cancer. Gastroenterol Clin North Am. 2012 Mar;41(1):179-88. doi: 10.1016/j.gtc.2011.12.014. Epub 2012 Jan 16.

  PMID: 22341257 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Shyam Varadarajulu, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 23, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)