Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT03444051
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2018-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors
Sponsor:
Société Française d'Endoscopie Digestive
Organization:
Study Overview
Official Title:
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.
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mousquetaires
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: