Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors

Pancreatic Tumor Clinical Trial

— Mousquetaires  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444051
• Other study ID #: Mousquetaires
• Status: Completed
• Phase: N/A
• First received: February 18, 2018
• Last updated: February 18, 2018
• Start date: March 1, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: February 2018
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 15, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Pancreatic Tumor
• Puncture

Intervention

Procedure:
• EUS-FNB with 20-gauge Procore® needle
Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 20-gauge Procore® needle
• EUS-FNB with 22-gauge Acquire® needle
Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 22-gauge Acquire®

Locations

Country	Name	City	State
France	Clinique PARIS-BERCY	Charenton-le-Pont

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic mass anatomopathological characterization	pancreatic mass anatomopathological characterization, presence of histological sampling and cumulative length of tissue core biopsies per needle pass.	in the 7 days after procedure