Confocal Laser Endomicroscopy Assisted Endobronchial Ultrasound-guided- Transbronchial Mediastinal Cryobiopsy Via a Tunnel for Diagnosing Mediastinal Lymphadenopathy

NANot yet recruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Mediastinal Lymphadenopathy
Interventions
PROCEDURE

nCLE assisted endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel

Patients received 2.5mL of 10% Fluorescite intravenously during nCLE. The CLE probe was preloaded into a puncture dilation catheter and locked into position with 2mm being exposed beyond the tip. puncture dilation catheter. The lymph node was punctured and the needle positioned at its center. The probe was advanced and locked, and the needle was advanced to the contralateral edge of the lymph node. Image acquisition began at the lymph node capsule, and then the subcapsular region, followed by the cortical sinus. When the image showed granuloma or malignant characteristics, the location will be recorded in EBUS, and retract the CLE probe, leaving the sheath of puncture dilation catheter as a tunnel between airway wall and target lymph node. Then, a 1.1-mm cryoprobe was inserted into the target lymph node through this tunnel under the EBUS guidance. The probe was cooled with liquid carbon dioxide for 5-9 seconds. Then retracted with the bronchoscope and the frozen biopsy tissue.

PROCEDURE

Endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel

First a tunnel between airway wall and mediastinal and/or hilar lesion was made by a puncture dilation catheter (BroncTruTM AK-91-55, Broncus Inc. Hangzhou, China). The 1.1mm cryoprobe (Erbe 20402-401, ERBE, Tübingen, Germany) entered the target lymph node through the tunnel under direct monitoring of EBUS, and the distance between the tip of the cryoprobe and the border of 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. Then retracted with the bronchoscope and the frozen biopsy tissue. Samples were retrieved by thawing in saline and then fixed in formalin. The same lymph node was operated for 3 times.

Trial Locations (1)

100029

China-Japan Friendship Hospital, Beijing

All Listed Sponsors
lead

China-Japan Friendship Hospital

OTHER

NCT06741852 - Confocal Laser Endomicroscopy Assisted Endobronchial Ultrasound-guided- Transbronchial Mediastinal Cryobiopsy Via a Tunnel for Diagnosing Mediastinal Lymphadenopathy | Biotech Hunter | Biotech Hunter