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

February 4, 2026 updated by: Gang Hou, China-Japan Friendship Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

469

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18years;
  2. Patients with clinical and radiological suspicion of stage I or stage II sarcoidosis;
  3. Fully informed of the purpose and method of the study

Exclusion Criteria:

  1. Pathologically confirmed sarcoidosis, obvious organ involvement with the possibility of confirming granulomas using a minimally invasive diagnostic procedure;
  2. Patients with medical contraindications to bronchoscopy procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBUS-TBMC
Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBMC
Procedure: EBUS-TBMC based sampling method
Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC.
Experimental: EBUS-TBNA
Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBNA
Procedure: EBUS-TBNA-based sampling methods
Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days after sampling

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 Month after sampling
Negative predictive value
Time Frame: 6 months after sampling
6 months after sampling
Incidence of complications
Time Frame: 4 weeks after sampling
4 weeks after sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DETECTION-SAR-II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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