NCT03567863

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Société Française d'Endoscopie Digestive · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreas Cancer
• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®	The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC)
DEVICE	22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®	The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)

Timeline

• Start date: 2018-06-24
• Primary completion: 2019-09-29
• Completion: 2019-09-29
• First posted: 2018-06-26
• Last updated: 2019-10-01

Locations

1 site across 1 country: France