Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles
Condition: Pancreas Cancer; Pancreatic Adenocarcinoma
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

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
    

Intervention name(s): 20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®; 22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®
Intervention type(s): Device; Device
Intervention description(s): The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC); The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic