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

Phase 3

Completed

• Conditions: Pancreatic Mass; Pancreatic Solid Lesions
• Interventions: Device: Capillary suction technique for EUS FNA; Device: Standard technique EUS-FNA

• Registration Number: NCT01936467
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-06
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2016-08-20
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Results First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capillary suction	Capillary suction technique for EUS FNA	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.
Standard suction	Standard technique EUS-FNA	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Howard County General Hospital; 🇺🇸 Columbia, Maryland, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States