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NCT Number: NCT07246876

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

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.

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Key information

About this study

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. Two questions remain need to be answered: (1) Does EBUS-TBMC have the same or better diagnostic sensitivity for sarcoidosis than EBUS-TBNA combined with standard bronchoscopic modalities (EBB or/and TBLB)? (2) Can combining EBUS-TBMC with standard bronchoscopic modalities further increase the diagnostic sensitivity for sarcoidosis? This study is designed as a randomised controlled trial to compare the diagnostic yield between EBUS-TBMC and conventional bronchoscopic approaches for diagnosing stage I/II sarcoidosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

EBUS-TBNA-based sampling methods

Procedure

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

EBUS-TBMC based sampling method

Procedure

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

Primary outcomes

  1. The granuloma detection rate

    Time frame: 7 days after sampling

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

Secondary outcomes

  1. Diagnostic yield

    Time frame: 6 Month after sampling

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

  2. Negative predictive value

    Time frame: 6 months after sampling

  3. Incidence of complications

    Time frame: 4 weeks after sampling

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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