Comparison of Two Fine Needle Biopsy Needles for Solid Pancreatic Masses

NCT02910960 | Completed DMC

• 1 other identifier: 886967
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized prospective clinical study comparing the Acquire Biopsy Device to SharkCore Biopsy Device.

Conditions

Pancreatic Neoplasm

Keywords

fine needle biopsy; EUS; solid pancreatic mass

Outcome Measures

Primary Outcomes (1)

• Total area of procured tissue between the two FNB needles

  The primary objective of this study is to compare the total area of procured tissue between the two FNB needles in patients undergoing EUS-guided sampling of pancreatic masses. Pancreatic masses sampled using the Acquire Endoscopic Ultrasound Fine Needle Biopsy Device needle should yield a tissue volume greater than the SharkCore Fine Needle Biopsy System needle because the serrated design of the FNB needle tip is expected to procure greater volume of tissue. This will be measured using a specialized digital image analysis software. This hypothesis will be tested by comparing the total tissue volume, tumor volume within the tissue, stroma volume within the tissue, tumor vs. stroma ratio and the macroscopic length of the procured tissue measured in millimeters. When evaluated together, the above measurement provide the total area of tissue procured.

  48 hours

Secondary Outcomes (1)

• Diagnostic adequacy between the two FNB needles

  48 hours

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

SharkCore Biopsy System

ACTIVE COMPARATOR

All patients will undergo sampling of pancreatic masses using the SharkCore Biopsy System. 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: SharkCore Biopsy System

Interventions

Acquire EUS Biopsy Device DEVICE

At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or SharkCore Biopsy System.

Acquire EUS Biopsy Device

SharkCore Biopsy System DEVICE

At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or SharkCore Biopsy System.

SharkCore Biopsy System

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 (6)

• 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

• Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6):1432-1438. doi: 10.1016/j.gie.2017.11.036. Epub 2018 Jan 3.

  PMID: 29305893 DERIVED

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 22, 2016
• Study Start: December 1, 2016
• Primary Completion: July 28, 2018
• Study Completion: October 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)