Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors

Completed

• Conditions: Pancreatic Tumor; Puncture
• Interventions: Procedure: EUS-FNB with 20-gauge Procore® needle; Procedure: EUS-FNB with 22-gauge Acquire® needle

• Registration Number: NCT03444051
• Lead Sponsor: Société Française d'Endoscopie Digestive

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 Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-15
• Status Verified: 2018-02
• Study First Submitted: 2018-02-18
• Study First Submitted QC: 2018-02-18
• Last Update Submitted: 2018-02-18
• Study First Posted: 2018-02-23
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
20-gauge Procore®	EUS-FNB with 20-gauge Procore® needle	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
22-gauge Acquire®	EUS-FNB with 22-gauge Acquire® needle	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

Primary Outcome Measures

Name	Time	Method
pancreatic mass anatomopathological characterization	in the 7 days after procedure	pancreatic mass anatomopathological characterization, presence of histological sampling and cumulative length of tissue core biopsies per needle pass.

Trial Locations

Locations (1)

Clinique PARIS-BERCY; 🇫🇷 Charenton-le-Pont, France