Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors (Mousquetaires)

Société Française d'Endoscopie Digestive

Status: Completed

Conditions: Puncture; Pancreatic Tumor

Treatments: Procedure: EUS-FNB with 22-gauge Acquire® needle; Procedure: EUS-FNB with 20-gauge Procore® needle

Study type: Observational

Funder types: Other

Identifiers

NCT03444051

Mousquetaires

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

68 participants in 2 patient groups

20-gauge Procore®

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® during the period study

Treatment:

Procedure: EUS-FNB with 20-gauge Procore® needle

22-gauge Acquire®

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 22-gauge Acquire® during the period study

Treatment:

Procedure: EUS-FNB with 22-gauge Acquire® needle