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

Study Overview
=================
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.

Official Title
-----------------
Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided

Conditions
-----------------
Pancreatic Solid Lesions, Pancreatic Mass

Intervention / Treatment
-----------------
* Device: Standard technique EUS-FNA
* Device: Capillary suction technique for EUS FNA


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard suction<br>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<br>* 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.<br>|
| Experimental: Capillary suction<br>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<br>* 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<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EUS, Pancreatic solid lesions, Pancreatic mass, Pancreatic cancer, Endoscopic Ultrasound, Fine needle aspiration, FNA, EUS-FNA