Comparison of the 20-gauge Procore® and 22-gauge Acquire® Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) of Solid Pancreatic or Peripancreatic Masses: an Observational Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Tumor
- Sponsor
- Société Française d'Endoscopie Digestive
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- pancreatic mass anatomopathological characterization
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore® and 22-gauge Acquire® needles. In total, 68 patients were recruited. Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge Procore® group and 97% of patients (33/34) in the 22-gauge Acquire® group (P=0.1). Core biopsy specimens obtained were significantly longer with the 22-gauge Acquire® needle with a mean cumulative length of tissue core biopsies per needle pass of 4,33±3,46mm vs. 7,9±4,35mm for the 20-gauge Procore® (P<0,01). Reproducibility of this simple histological criterion was validated in intra and inter-observer.
Detailed Description
Between March and December 2017, 68 EUS-FNB were consecutively performed in our unit for a pancreatic or peripancreatic mass. The choice of the needle depended upon the availability at the time of admission: 34 punctures were performed with a 20-gauge Procore®, and 34 with a 22-gauge Acquire®. Histological material was studied in a blinded manner with respect to the needle, and cumulative length of tissue core biopsies per needle pass was determined. Intra and inter-observer variability of this criterion was then evaluated.
Investigators
KARSENTI
principal investigator
Société Française d'Endoscopie Digestive
Eligibility Criteria
Inclusion Criteria
- •All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included
Exclusion Criteria
- •non-accessible pancreatic mass because of history of Billroth II or Roux-en-Y reconstruction
- •coagulation disorders (such as partial thromboplastin time \>42 seconds, prothrombin time \[Quick value\] \<50%, platelet count \<50 000/mm³), treatment with clopidogrel, pregnancy.
- •patients \<18 years of age
Outcomes
Primary Outcomes
pancreatic mass anatomopathological characterization
Time Frame: in the 7 days after procedure
pancreatic mass anatomopathological characterization, presence of histological sampling and cumulative length of tissue core biopsies per needle pass.