Study on Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Via a Tunnel in the Diagnosis of Mediastinal Lymphadenopathy

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.

Study arms

• Experimental
  EBUS-TBMC via a tunnel first group

  After completing the routine bronchoscopy examination, under the EBUS guidance, combined with the results of chest CT to determine the location of puncture. Then, a disposable puncture dilation catheter (BroncTru AK-91-55; Broncus Inc., Hangzhou, China) was inserted through the working channel of the ultrasound bronchoscope and built a tunnel between the airway wall and targeted lymph node. The 1.1-mm cryoprobe (Erbe 20402-401; ERBE, Tübingen, Germany) was inserted into the target lymph node through the tunnel under direct EBUS monitoring, and the distance between the tip of the cryoprobe and the border of the target lymph node was measured using EBUS. After confirming that the distance was \>5 mm, the probe was cooled with liquid carbon dioxide for 5-9 seconds and freezing 3 times to obtain 3 pieces of sample. At the end of TBMC via a tunnel, EBUS-TBNA is performed in the same lymph node, and the tissue is aspirated repeatedly for 5 strokes (one stroke is 30 round trips).

  Procedure: EBUS-TBNA · Procedure: EBUS-TBMC via a tunnel

• Experimental
  EBUS-TBNA first group

  Completion of routine bronchoscopy, determination of the puncture position under EBUS guidance, combined with the results of chest CT, and application of the EBUS-TBNA needle to repeatedly aspirate the tissue for 5 strokes (one stroke is 30 round trips ). At the end of the puncture, EBUS-TBMC via a tunnel was then performed with a freezing time of 5-9 seconds (1.1-mm cryoprobe), and frozen 3 times to obtain 3 pieces of samples.

  Procedure: EBUS-TBNA · Procedure: EBUS-TBMC via a tunnel

Interventions

• ProcedureEBUS-TBNA

  Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.

• ProcedureEBUS-TBMC via a tunnel

  Participants with lymphadenopathy would receive EBUS-TBMC via a tunnel attempts to conduct diagnoses.

Primary outcomes

1. Diagnostic yield

   The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis was established. All the final diagnosis in this trial were established by the treating clinician and verified by an independent diagnosis verification panel which included three pulmonary and critical care medicine physicians, one radiologist, and one pathologist.

   Time frame: 6 months after the biopsy

Secondary outcomes

1. Diagnostic sensitivity

   The proportion of individuals who truly had the disease and tested positive.

   Time frame: 6 months after biopsy.

2. Incidence rate of adverse events

   Symptoms and signs

   Time frame: 7 days after the biopsy

3. Size of specimen

   measurement

   Time frame: during the procedure

4. Specimen quality

   questionnaire

   Time frame: during the procedure

Publications

• Deng M, Zheng Z, Zhang X, Xia Y, Tang F, Yang Z, Zhong C, Tong R, Zhou G, Li X, Zhao L, Dai H, Hou G. EBUS-guided transbronchial mediastinal cryobiopsy for diagnosing non-metastatic lymphadenopathy: A randomized controlled trial. Med. 2026 Feb 13;7(2):100962. doi: 10.1016/j.medj.2025.100962. Epub 2026 Jan 26. PubMed 41592566 ↗

Individual participant data

Plan to share: No