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

Phase 3CompletedNCT01936467

Johns Hopkins University121 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

121

Conditions

Pancreatic Solid Lesions Pancreatic Mass

Interventions

Capillary suction technique for EUS FNADEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Howard County General Hospital

Columbia, Maryland, United States

Outcomes

Primary Outcomes

Diagnostic Yield of Capillary Technique

Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.

Time frame: up to 6 months

Diagnostic Yield of Standard Technique

Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.

Time frame: up to 6 months

Sensitivity of EUS-FNA With Capillary Technique

Sensitivity of the EUS-FNA with Capillary technique

Time frame: 6 months

Sensitivity of EUS-FNA With StandardTechnique

Sensitivity of the EUS-FNA with Capillary technique

Time frame: 6 months

Sensitivity of EUS-FNA

Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions

Time frame: 6 months

Secondary Outcomes

First Pass Diagnostic Rate

The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass

Time frame: immediate

Acquisition of Core Tissue

The rate of acquiring core tissue of the pancreatic mass through EUS-FNA

Time frame: immediate

Diagnostic Accuracy of EUS-FNA

The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease

Time frame: 6 months