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NCT06741852
Confocal Laser Endomicroscopy Assisted Endobronchial Ultrasound-guided- Transbronchial Mediastinal Cryobiopsy Via a Tunnel for Diagnosing Mediastinal Lymphadenopathy
NA trial testing nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel in Mediastinal Lymphadenopathy in 98 participants. Not yet recruiting.
31 December 2025
Quick facts
| Lead sponsor | China-Japan Friendship Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | diagnostic |
| Enrollment | 98 |
| Start date | 1 January 2025 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel
- Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel
Conditions studied
- Mediastinal Lymphadenopathy — all drugs for Mediastinal Lymphadenopathy →
Sponsor
China-Japan Friendship Hospital
Who can join
18 and older, any sex, with Mediastinal Lymphadenopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Mediastinal and/or hilar lymphadenopathy (MHL) becoming more and more common in clinical practice with the development of imaging technique. MHL is secondary to various benign and malignant disorders that could be life-threatening conditions due to compression of airways or blood vessels. Accurate and timely diagnosis is important for managing patients with lymphadenopathy. Nowadays, several invasive mediastinal tissue samplings have been designed and development. For patients with metastatic lymphadenopathy, endobronchial ultrasound (EBUS) guided transbronchial needle aspiration has been recommended as a first-line diagnostic method by several guidelines due to its highly diagnostic sensitivity for non-small cell lung cancer and acceptable safety.However, the relatively limited material retrieved by needle aspiration restricts its diagnostic yield in non-metastatic lymphadenopathy including sarcoidosis, lymphoma, tuberculosis, etc.6,7 It is important to obtain the representative sample which showed the specific pathology for diagnosing patients with non-metastatic lymphadenopathy. Therefore, previous studies attempt to use transbronchial mediastinal cryobiopsy (TBMC) to obtain acquiring samples with sufficient volume suitable for histological and molecular analyses. Despite several studies have proved that TBMC has a highly diagnostic yield, the heterogeneity of pathologic characteristics in lymph node makes obtaining a representative sample difficult. To overcome the sampling heterogeneity and obtain the possibility of obtaining a representative sample in mediastinal lesions, increasing sampling number had been proved as an effective method in previous studies (5-times TBNA, thrice TBMC). With the increasing sampling number, the potential risk related to the procedure is higher than before. Needle-based confocal laser endomicroscopy (nCLE) is a laser-based imaging technique that utilizes fluorescence for real-time microscopic imaging at the biopsy needle tip. Compared to EBUS, nCLE enables real-time visualisation of cell shapes, there by acting a real-time microscope. Besides, we had developed a novel procedure which can built a tunnel between airway wall and target lymph node using a puncture dilation catheter and allows various tools to perform procedure, its efficacy and safety had been proved in our published studies.Based on this tunnel, we could perform TBMC under the nCLE guidance. The area with representative pathology of lymph node may be detected by nCLE, and shorten the sampling number. However, it remains unknown which of these techniques is the superior match for needle biopsy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
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Currently open trials in the same condition.
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- NCT06347939 — Mediastinal EBUS Cryobiopsy Study In Sweden · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06741852 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China-Japan Friendship Hospital
- Last refreshed: 19 December 2024
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