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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
60
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)
David Karsenti
Charenton-le-Pont, Île-de-France Region, France
cumulative length of tissue core biopsies per needle pass
cumulative length of tissue core biopsies per needle pass in mm
Time frame: in the 7 days after procedure
Presence of core biopsy specimen
Presence of core biopsy specimen
Time frame: in the 7 days after procedure
Sensitivity
EUS-FNB Sensitivity for the diagnosis of adenocarcinoma of the pancreas
Time frame: in the 7 days or 6 months
Specificity
EUS-FNB Specificity for the diagnosis of adenocarcinoma of the pancreas
Time frame: in the 7 days or 6 months
Positive Predictive Value
EUS-FNB Positive predictive value for the diagnosis of adenocarcinoma of the pancreas
Time frame: in the 7 days or 6 months
Negative Predictive Value
EUS-FNB Negative Predictive Value for the diagnosis of adenocarcinoma of the pancreas
Time frame: 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
Time frame: 6 months
Success rate of isolation of tumor cells
Success rate of isolation of tumor cells
Time frame: 6 months
Morbidity
Puncture Morbidity (acute pancreatitis, haemorrhage)
Time frame: 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)
Time frame: 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)
Time frame: 7 days
determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes
determination of transcriptomic signatures of pancreatic adenocarcinoma subtypes
Time frame: 6 months
intra-observer evaluation of the anatomopathological criteria used
intra-observer evaluation of the anatomopathological criteria used
Time frame: 7 days
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