Comparation Between Needles for EUS-guided Sampling of Solid Pancreatic Lesions

Study Overview
=================
Brief Summary
-----------------
This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.

Detailed Description
-----------------
This is a randomized trial conducted at a unique center. The aim of this study is to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate. Patients with a suspected solid pancreatic lesion larger than 15 mm, identified by CT or MRI and referred to EUS-guided sampling will be eligible for inclusion. Patients will be excluded in case of cystic lesion, or the lesion was not detected in EUS, or if the coagulation parameters are abnormal (INR> 2, platelet count < 50,000). The pancreatic mass will be puncture, for expert endoscopist, firstly with a needle according to randomization, followed by another one. Will be make a touch print with the specimen obtained with the needles and, subsequently, all the specimen will be put in formaldehyde solution for cell-block analysis. Diagnostic yield of cell block will be defined as enough histologic tissue core containing pancreatic parenchyma or tumor with dysplastic cells enough for the correct tissue diagnosis. In the presence of malignant tissue in core specimens, it will be calculated the proportion of the area positive for malignancy compared to the total area of the core and then the each needle yield will be defined.

Official Title
-----------------
Prospective Randomized Study Comparing the 25-gauge Franseen Needle and the 25-gauge Standard Needle for EUS-guided Fine-needle Sampling of Solid Pancreatic Lesions Without Rapid on Site Evaluation

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Device: needle punction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - solid pancreatic lesion larger than 15 mm Exclusion Criteria: pancreatic cystic lesion lesion not detected in EUS abnormal coagulation parameters (INR> 2, platelet count < 50,000)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard FNA 22G needle<br>The pancreatic mass will be puncture, for expert endoscopist, with a standard FNA 22G needle | Device: needle punction<br>* EUS-guided sampling of pancreatic solid lesions obtained with the 22-gauge<br>|
| Experimental: Franseen 22G needle<br>The pancreatic mass will be puncture, for expert endoscopist, with a FNB 22G needle. The sequence of the use of needles will be randomized. | Device: needle punction<br>* EUS-guided sampling of pancreatic solid lesions obtained with the 22-gauge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the diagnostic yield | compare the diagnostic yield between two EUS needles | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extra passes with each needle | number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry | 2 years | 
| perform immunohistochemistry | need to perform immunohistochemistry to reach the result | 2 years | 
| adverse event rate | to assess the adverse event rate | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
accuracy, pancreatic cancer, endoscopic ultrasound-guided