Comparison Of Two Needle Aspiration Techniques For Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) In Solid Pancreatic Lesions

Study Overview

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

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 ⋊pillary 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.

N/A

Pancreatic Solid Lesions
Pancreatic Mass

DEVICE: Standard technique EUS-FNA
DEVICE: Capillary suction technique for EUS FNA

NA_00079301

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-08-29	Results First Submitted 2016-08-20	Last Update Submitted that met QC Criteria 2017-03-02
First Submitted that Met QC Criteria 2013-09-03	Results First Submitted that Met QC Criteria 2017-03-02	Last Update Posted (ACTUAL) 2017-04-13
First Posted (ACTUAL) 2013-09-06	Results First Posted 2017-04-13	Last Verified 2017-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

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	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 provi

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

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 provi

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Boston Scientific Corporation

Investigators

PRINCIPAL_INVESTIGATOR: Mouen A Khashab, MD, Johns Hopkins Univeristy

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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.

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Clinical Trial Record