Diagnostic Value of EBUS-Guided Transbronchial Mediastinal Cryobiopsy Versus Conventional Bronchoscopic Approaches for Stage I/II Sarcoidosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital

About this trial

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), combined with endobronchial biopsy (EBB) and/or transbronchial lung biopsy (TBLB), and endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) have high diagnostic yields for patients with sarcoidosis. However, a direct comparison between them has not been conducted. This randomized controlled trial aims to compare directly the diagnostic yield between EBUS-TBMC and EBUS-TBNA+EBB+TBLB in sarcoidosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18years;

Patients with clinical and radiological suspicion of stage I or stage II sarcoidosis;

Fully informed of the purpose and method of the study

Disqualifiers

Pathologically confirmed sarcoidosis, obvious organ involvement with the possibility of confirming granulomas using a minimally invasive diagnostic procedure;

Patients with medical contraindications to bronchoscopy procedures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EBUS-TBNA-based sampling methods

    Procedure/Surgery

    Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA.

  • EBUS-TBMC based sampling method

    Procedure/Surgery

    Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC.

Treatment groups

469 Participants
are divided into 2 treatment groups
Group A: EBUS-TBMCExperimental treatment 1 intervention
Group B: EBUS-TBNAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The granuloma detection rate

The number of patients with granulomas detected relative to the total number of patients tested.

Time frame
7 days after sampling

Secondary outcomes

1

Diagnostic yield

The proportion of all participants who underwent the diagnostic procedure in whom a specific malignant or benign diagnosis was established

Time frame
6 Month after sampling
2

Negative predictive value

Time frame
6 months after sampling
3

Incidence of complications

Time frame
4 weeks after sampling

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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