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Study Comparing Pancreatic EUS-FNB With the 20-gauge Procore® and the 22-gauge Acquire® Needles

NCT03567863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-01

No results posted yet for this study

Summary

Multicenter randomized prospective study

Criteria for inclusion:

Patients admitted for EUS-FNB of a pancreatic mass

Goals of the study:

To compare the results of blinded punctures for suspicion of pancreatic tumor performed under endoscopic ultrasound in our center (Digestive Endoscopy Unit of the Digestive Pole Paris Bercy, PDPB), in terms of diagnosis and quality of histopathological material obtained with the help of 20G Procore, Cook and 22G Acquire needles, Boston Scientific.

Main criterion:

\- Biopsy core length of target tissue obtained by needle pass

Number of patients:

60 patients

Duration of the study:

1 year

Conditions

  • Pancreas Cancer
  • Pancreatic Adenocarcinoma

Interventions

DEVICE

20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®

The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC)

DEVICE

22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®

The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)

Sponsors & Collaborators

  • Société Française d'Endoscopie Digestive

    lead OTHER

Principal Investigators

  • David Karsenti, MD · Société Française d'Endoscopie Digestive

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-24
Primary Completion
2019-09-29
Completion
2019-09-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567863 on ClinicalTrials.gov