Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors

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.

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Key information

Conditions

Pancreatic Tumor Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Puncture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique PARIS-BERCY

Charenton-le-Pont, 94220, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS-FNB with 20-gauge Procore® needle

Procedure

Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 20-gauge Procore® needle

EUS-FNB with 22-gauge Acquire® needle

Procedure

Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 22-gauge Acquire®

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.

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study 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.

Acronym: Mousquetaires

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Feb 23, 2018
Registry last updated: Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed