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EBUS vs EUS-B for Diagnosing Sarcoidosis

NCT02540694 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2015-09-04

No results posted yet for this study

Summary

Rationale:

Endosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose sarcoidosis stage I and II - in case tissue verification of noncaseating granulomas is indicated. However, the optimal endosonographic approach (endobronchial or transoesophageal) for mediastinal nodal sampling is under discussion.

Secondly, which needle size or type provides optimal tissue sample quality for granuloma detection is unknown. The novel 25 Gauge (G) beveled ProCore needle, allows tissue acquisition of small core biopsies in addition to cytological aspirates.

Hypotheses:

1. Esophageal ultrasound guided (EUS-B) sampling of intrathoracic lymph nodes has a 14% higher granuloma detection rate compared to endobronchial ultrasound (EBUS) guided nodal sampling in patients with suspected sarcoidosis stage I/II.
2. 25G ProCore needles provide superior sample quality compared to conventional 22G needles in patients with suspected sarcoidosis stage I/II.

Study design:

Investigator initiated, randomized clinical trial. Setting: International, multicenter (university and general hospitals)

Study population:

Consecutive patients with a clinical and radiologic suspicion of sarcoidosis stage I or II and an indication for tissue verification of non-caseating granulomas are eligible for inclusion.

Intervention:

EBUS vs EUS-B, simultaneously comparing the standard vs novel ProCore needles.

Main study endpoints:

1. The granuloma detection rate of endobronchial (EBUS) guided sampling of intrathoracic lymph nodes compared to esophageal (EUS-B using the EBUS scope) guided sampling in patients with suspected sarcoidosis stage I/II.
2. Sample quality of conventional 22G vs. 25G ProCore needles in patients with suspected sarcoidosis stage I/II.

Conditions

  • Sarcoidosis
  • Endosonography

Interventions

DEVICE

Endosonography

Sponsors & Collaborators

  • Cook Medical

    collaborator UNKNOWN

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Jouke T Annema, Prof · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-11-30
Completion
2018-06-30

Countries

  • Netherlands

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 NCT02540694 on ClinicalTrials.gov