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

NCT07246876 | Not Yet Recruiting DMC

• 1 other identifier: DETECTION-SAR-II
• Study Type: interventional
• Target: 469
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sarcoidosis, Pulmonary

Keywords

Endobronchial Ultrasound; EBUS-TBNA; EBUS-transbronchial mediastinal cryobiopsy; Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• The granuloma detection rate

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

  7 days after sampling

Secondary Outcomes (3)

• Diagnostic yield

  6 Month after sampling

• Negative predictive value

  6 months after sampling

• Incidence of complications

  4 weeks after sampling

Study Arms (2)

EBUS-TBMC

EXPERIMENTAL

Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBMC

Procedure: EBUS-TBMC based sampling method

EBUS-TBNA

EXPERIMENTAL

Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBNA

Procedure: EBUS-TBNA-based sampling methods

Interventions

EBUS-TBNA-based sampling methods PROCEDURE

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

EBUS-TBNA

EBUS-TBMC based sampling method PROCEDURE

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

EBUS-TBMC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Related Publications (1)

• Zheng Z, Wang H, Guo J, Zhang Q, Tang F, Xu L, Deng MM, Herth F, Poletti V, Hou G. Diagnostic Value of EBUS-guided Transbronchial MEdiastinal Cryobiopsy versus ConvenTIONal Bronchoscopic Approaches for Intrathoracic Stage I/II SARcoidosis: protocol for a randomised controlled trial (DETECTION-SAR-II). BMJ Open Respir Res. 2026 Mar 19;13(1):e004065. doi: 10.1136/bmjresp-2025-004065.

  PMID: 41856756 DERIVED

MeSH Terms

Conditions

Sarcoidosis, Pulmonary; Sarcoidosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 24, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02