Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions

Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided

The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for solid pancreatic lesions. Investigators hope to discover the best technique for obtaining diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and fine needle aspirate procedure.

There are currently several techniques for obtaining tissue during endoscopic ultrasound and fine needle aspirate. The procedure will be performed by either the capillary suction technique or no suction technique.

Study Overview

• Status: Completed
• Conditions: Pancreatic Solid Lesions; Pancreatic Mass
• Intervention / Treatment: Device: Standard technique EUS-FNA; Device: Capillary suction technique for EUS FNA

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Columbia, Maryland, United States, 21044
      • Howard County General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- In-patients and out-patients between the age of 18years and 90 years with pancreatic masses presenting for EUS-FNA

Exclusion Criteria:

• Uncorrectable coagulopathy (INR > 1.5)
• Uncorrectable thrombocytopenia (platelet < 50,000)
• Uncooperative patients
• Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
• Refusal to consent form
• Cystic lesions
• Inaccessible lesions to EUS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard suction; These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.	Device: Standard technique EUS-FNA; Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
Experimental: Capillary suction; These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.	Device: Capillary suction technique for EUS FNA; Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Yield of Capillary Technique	Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.	up to 6 months
Diagnostic Yield of Standard Technique	Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.	up to 6 months
Sensitivity of EUS-FNA With Capillary Technique	Sensitivity of the EUS-FNA with Capillary technique	6 months
Sensitivity of EUS-FNA With StandardTechnique	Sensitivity of the EUS-FNA with Capillary technique	6 months
Sensitivity of EUS-FNA	Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Pass Diagnostic Rate	The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass	immediate
Acquisition of Core Tissue	The rate of acquiring core tissue of the pancreatic mass through EUS-FNA	immediate
Diagnostic Accuracy of EUS-FNA	The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease	6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Mouen A Khashab, MD, Johns Hopkins Univeristy

Publications and helpful links

General Publications

• Saxena P, El Zein M, Stevens T, Abdelgelil A, Besharati S, Messallam A, Kumbhari V, Azola A, Brainard J, Shin EJ, Lennon AM, Canto MI, Singh VK, Khashab MA. Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial. Endoscopy. 2018 May;50(5):497-504. doi: 10.1055/s-0043-122381. Epub 2017 Dec 22.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: September 3, 2013
• First Posted (Estimate): September 6, 2013

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: EUS-FNA; FNA; Pancreatic cancer; EUS; Endoscopic Ultrasound; Fine needle aspiration; Pancreatic mass; Pancreatic solid lesions
• Other Study ID Numbers: NA_00079301