Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the diagnostic gain between 22G standard needle vs 19G Flex needles transduodenal punctures of masses of the pancreatic head.

Detailed Description
-----------------
The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic masses is about 70 - 80 % with the 22G standard needle. Pancreatic adenocarcinoma is known to have a severe prognosis and a low rate of survival even after curative surgery. The study of pancreatic solid tumors is one the main diagnostic problem present in the investigators daily practice. In most of non operated patients, EUS-FNA is the sole possibility to confirm the diagnosis of malignancy which is required to initiate chemotherapy and/or radiotherapy. To improve the performances of the EUS-FNA, new needles are now disposable either with a cutting window design (EchoTip ProCore-COOK Medical) or flexible 19G needle (19G Expect Flex - Boston-Scientific). The goal is to obtain more tissue material with the possibility of a histologic study without increasing the risk of the puncture which is very low (complications rate < 1%). The problem concerns the lesion of the head of the pancreas requiring a trans-duodenal access for the puncture . In this position, the needle is very difficult to push out the operator channel and, in some cases, the puncture is quite impossible with stiff needles as ProCore or standard 19G. Thus, the interest of flexible 19G needle is to be used in difficult technical cases as transduodenal access for head pancreatic tumors, with a good safety and more efficacy than 22G needles.

Official Title
-----------------
Randomized, Comparative Study of 19G Flex Versus 22G Standard Needles for Pancreatic Solid Tumors Diagnosis.

Conditions
-----------------
Adenocarcinoma of Head of Pancreas

Intervention / Treatment
-----------------
* Device: puncture of head of pancreas
* Device: puncture of head of pancreas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with solid tumor of pancreas who has to receive a biopsy under endoscopic ultrasound (EUS) patient who understands the study procedures, risks and voluntarily agrees to participate by giving written informed consent Exclusion Criteria: patient who participates in an other study patient mentally or legally incapacitated patient with contraindications to the achievement of upper gastrointestinal endoscopy patient with haemorrhagic disease, disorder of hemostasis and coagulation (TP<60%, TCA>40sec and platelets <60000/mm3) patient with anticoagulant or antiaggregating treatment that could not be stopped for the endoscopic procedure patient with pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging) patient pregnant or lactating women

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 19G flex needle puncture<br>puncture of head of pancreas | Device: puncture of head of pancreas<br>* puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. randomization: puncture with either 22G needle or 19G flex needle<br>|
| Active Comparator: 22G needle puncture<br>puncture of head of pancreas | Device: puncture of head of pancreas<br>* puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. randomization: puncture with either 22G needle or 19G flex needle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of 19G Flex Expect needle in the histological diagnosis of pancreatic solid tumors of the head of pancreas | accuracy and diagnostic gain of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic tumors of the head of pancreas: comparison between 19G Flex and 22G standard needles punctures. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity | immediate per-procedure complications and delayed morbidity (up to day 30) side effects resulting of technical failure or dysfunction of the puncture ease of handling for the two needles (visual analogic scale) | 2 minutes, up to day 30 | 
| quality of histology | quality of histological specimens obtained with the 2 types of needles (visual analogic scale) | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fine needle aspiration under ultrasound endoscopy, solid pancreatic tumors, head of pancreas, 19G Flex needle, 22G standard needle