Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors

NCT03444051 | Completed

• 1 other identifier: Mousquetaires
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Tumor; Puncture

Keywords

EUS-FNB; comparative study

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

20-gauge Procore®

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

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

22-gauge Acquire®

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

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

Interventions

EUS-FNB with 20-gauge Procore® needle PROCEDURE

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

20-gauge Procore®

EUS-FNB with 22-gauge Acquire® needle PROCEDURE

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

22-gauge Acquire®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included. The use of EUS-FNB needle was determined during EUS if the examination confirmed the presence of a pancreatic or peri-pancreatic non-hyper-vascular mass (on Doppler examination). According to the period of admission, the 20-gauge Procore® (Wilson Cook Medical, Winston-Salem, NC) and 22-gauge Acquire® needles (Boston Scientific Natick, MA) were alternatively available depending on the order (made in batches of 5 units). So, patients were included either in the 20-gauge Procore® group or the 22-gauge Acquire® group. Patients could be switched via a crossover procedure to a second EUS-FNB with the competitive needle if the first one failed to give histologic mass characterization: failure was recorded to the first needle group, and the second EUS-FNB performed with the alternate needle was recorded in the other group.

You may qualify if:

• All consecutive patients ≥18 who were referred for EUS-FNB for solid pancreatic or peripancreatic mass were included

You may not qualify if:

• 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

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (1)

Clinique PARIS-BERCY

Charenton-le-Pont, 94220, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: February 23, 2018
• Study Start: March 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 15, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)