Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles

Study Overview
=================
Brief Summary
-----------------
Multicenter randomized prospective study Criteria for inclusion: Patients admitted for EUS-FNB of a pancreatic mass Goals of the study: To compare the results of blinded punctures for suspicion of pancreatic tumor performed under endoscopic ultrasound in our center (Digestive Endoscopy Unit of the Digestive Pole Paris Bercy, PDPB), in terms of diagnosis and quality of histopathological material obtained with the help of 20G Procore, Cook and 22G Acquire needles, Boston Scientific. Main criterion: - Biopsy core length of target tissue obtained by needle pass Number of patients: 60 patients Duration of the study: 1 year

Detailed Description
-----------------
Type of study: Multicenter randomized prospective study Criteria for inclusion: Patients admitted for ENDOSCOPIC ULTRASOUND FINE NEEDLE BIOPSY (EUS-FNB) of a pancreatic mass Exclusion criteria: Patients with an extra-pancreatic mass puncture Echendoscopic puncture contraindication or vascular interposition Goals of the study: To compare the results of blinded punctures for suspicion of pancreatic tumor performed under endoscopic ultrasound in our center (Digestive Endoscopy Unit of the Digestive Pole Paris Bercy, PDPB), in terms of diagnosis and quality of histopathological material obtained with the help of 20G Procore, Cook and 22G Acquire needles, Boston Scientific. Evaluation criteria : Main criterion: - Biopsy core length of target tissue obtained by needle pass Secondary criteria Presence of a core biopsy specimen Sensitivity of EUS-FNB for the diagnosis of adenocarcinoma of the pancreas False negative rate, Negative predictive value for the diagnosis of pancreatic adenocarcinoma Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All core biopsy specimens Success rate of isolation of tumor cells and determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes Immediate complications of puncture Variation in the quality of the puncture following the trans-duodenal or trans-gastric access route Technical failure rate of puncture Optional: inter and intra-observer evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle passage) Number of patients: 60 patients Duration of the study: 1 year

Official Title
-----------------
Multicentric Randomized Study Comparing the Histological and Molecular Material Quality Obtained by EUS-FNB of Pancreatic Mass With Two Biopsic Needles: the 20-gauge Procore® (Cook) and the 22-gauge Acquire® (Boston Scientific)

Conditions
-----------------
Pancreas Cancer, Pancreatic Adenocarcinoma

Intervention / Treatment
-----------------
* Device: 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®
* Device: 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted to one of the investigative centers for endoscopic pancreatic puncture during the period from April 1, 2018 to April 1, 2019 Patient whose age is greater than or equal to 18 years and less than 90 years Patient ASA 1, ASA 2, ASA 3 (ASA: American Society of Anaesthesiologists Classification) Lack of participation in another clinical study Signed informed consent Exclusion Criteria: Patients punctured with an extra-pancreatic mass Patient under the age of 18 or over 90 Patient ASA 4, ASA 5 Pregnant woman Patient with coagulation abnormalities preventing puncture: TP <50%, Platelets <50000 / mm3, effective anticoagulation in progress, clopidogrel in progress Vascular or ductal or surgical fixation (Billroth II, Roux in Y) preventing endoscopic access to the lesion to be punctured Patient unable to personally consent

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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE® | Device: 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®<br>* The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC)<br>|
| Active Comparator: Group B<br>The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK) 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE® | Device: 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®<br>* The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative length of tissue core biopsies per needle pass | cumulative length of tissue core biopsies per needle pass in mm | in the 7 days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of core biopsy specimen | Presence of core biopsy specimen | in the 7 days after procedure | 
| Sensitivity | EUS-FNB Sensitivity for the diagnosis of adenocarcinoma of the pancreas | in the 7 days or 6 months | 
| Specificity | EUS-FNB Specificity for the diagnosis of adenocarcinoma of the pancreas | in the 7 days or 6 months | 
| Positive Predictive Value | EUS-FNB Positive predictive value for the diagnosis of adenocarcinoma of the pancreas | in the 7 days or 6 months | 
| Negative Predictive Value | EUS-FNB Negative Predictive Value for the diagnosis of adenocarcinoma of the pancreas | in the 7 days or 6 months | 
| Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface | Computer Aided Morphometric Evaluation of the Tumor + Stroma Surface on All Core biopsies | 6 months | 
| Success rate of isolation of tumor cells | Success rate of isolation of tumor cells | 6 months | 
| Morbidity | Puncture Morbidity (acute pancreatitis, haemorrhage) | 7 days | 
| Feasibility | Technical failure rate of puncture because of a impossibility to access to pancreatic mass with the needle (due to the needle stiffness) | during procedure | 
| inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass) | inter evaluation of the anatomopathological criteria used (presence of a biopsy core, length of target tissue core per needle pass) | 7 days | 
| determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes | determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes | 6 months | 
| intra-observer evaluation of the anatomopathological criteria used | intra-observer evaluation of the anatomopathological criteria used | 7 days |