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EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses

NCT03485924 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-09-19

Study results available
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Summary

The objective of this paired cohort study is to evaluate the diagnostic accuracy of Endoscopic Ultrasound-fine needle aspiration (EUS-FNA) with rapid onsite evaluation (ROSE) compared to EUS-fine needle biopsy (EUS-FNB) without ROSE. If EUS-FNB without ROSE is shown to be non-inferior to the current standard of care of EUS-FNA with ROSE in pancreatic lesions, this study has the potential to make EUS-guided tissue acquisition more economical (with elimination for the need for cytopathology staff onsite) as well as provide core histological specimen without sacrificing the overall diagnostic yield.

Conditions

  • Fine Needle Aspiration
  • Pancreatic Mass

Interventions

DIAGNOSTIC_TEST

EUS-FNA with ROSE

EUS-FNA with ROSE vs EUS-FNB without ROSE

DIAGNOSTIC_TEST

EUS-FNB without ROSE

EUS-FNA with ROSE vs EUS-FNB without ROSE

Sponsors & Collaborators

Principal Investigators

  • Mouen Khashab · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2023-07-26
Completion
2023-07-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03485924 on ClinicalTrials.gov