Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Background: Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate diagnosis of a pancreatic mass is important to direct patient management. Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To overcome these limitations, a new needle device with ProCore reverse-bevel technology was developed recently. Aims: The objective of this prospective study is to compare the rate of diagnostic sufficiency in the EUS sampling by using newly developed ProCore needle with conventional FNA needle in suspected unresectable pancreatic cancer. We will also compare the safety, the yield of histologic core tissue and the cost-effectiveness between these modalities.

Detailed Description
-----------------
Patient: Newly diagnosed pancreatic cancer patient whose cancer lesion is suspected unresectable in diagnostic imaging such as CT or MRI Procedure: Each EUS-guided FNA and ProCore aspiration will performed twice in same patient. The priority of order will be given by randomization assignment. The number of patients required: Total sixty five patients will be required.

Official Title
-----------------
Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Endoscopic Ultrasonography-guided Sampling of Suspected Unresectable Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Device: 22 gauge ProCore needle aspiration
* Device: 22 gauge Fine needle aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who agree to participate in research 18 years of age and older patients less than 80 years old Patients who have suspected unresectable pancreatic cancer in imaging studies Exclusion Criteria: Contraindication to endoscopy Patients younger than 18 years old or older than 80 years old Bleeding tendency Cardiopulmonary dysfunction Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 22 gauge ProCore needle aspiration<br>EUS-guided pancreatic mass aspiration with 22 gauge ProCore needle | Device: 22 gauge ProCore needle aspiration<br>* Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration<br>* Other names: EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle;|
| Active Comparator: 22 gauge Fine needle aspiration<br>EUS-guided pancreatic mass aspiration with 22 gauge Fine needle | Device: 22 gauge Fine needle aspiration<br>* Pancreatic mass evaluation through the 22 gauge Fine needle aspiration<br>* Other names: 22 gauge, EN-SHOT2 Side Port Aspiration Needle;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rates of diagnostic sufficiency | The rates of diagnostic sufficency will be assessed by the pathologist as the proportion of definate diagnosis from cytology and histology within 2 passes of each procendure | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of histologic core | The presence histologic core means the gain of tissue, not clustered cells, through each procedure. It will be also assessed by the pathologist. | Up to 1 year |