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Comparation Between Needles for EUS-guided Sampling of Solid Pancreatic Lesions

NCT04877340 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-05-07

No results posted yet for this study

Summary

This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.

Conditions

  • Pancreatic Neoplasms

Interventions

DEVICE

needle punction

EUS-guided sampling of pancreatic solid lesions obtained with the 22-gauge

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • FAUZE MALUF-FILHO, PHD · ICESP/FMUSP

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-26
Primary Completion
2022-11-30
Completion
2023-04-30

Countries

  • Brazil

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 NCT04877340 on ClinicalTrials.gov