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RECRUITING
NCT06921681
NA

Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

Sponsor: University of Zurich

View on ClinicalTrials.gov

Summary

EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information.

Official title: Transbronchial EBUS-guided TBNA and Cryobiopsy of Mediastinal Lymph Nodes in Patients Nonsuspicious for Lung Cancer, Using Different Cryoprobe Freezing Times

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2025-03-07

Completion Date

2029-12-31

Last Updated

2025-04-10

Healthy Volunteers

No

Interventions

DEVICE

Cryobiopsy of lymph nodes group 6 sec

Included patients receive transbronchial access with EBUS needle (19, 21 or 22 gauge needle) Hereafter, three times EBUS-TBNA followed by four EBUS-guided-CBs with a 1.1mm cryoprobe will be performed. Included patients are 1:1 randomized to receive CB with cryoprobe activated for either 3 sec of freezing time (group "3sec") or 6 sec. of freezing time (group "6sec") before the biopsy together with the whole EBUS bronchoscope is extracted. The EBUS-guided CB will be conducted four times in each group. Aiming access to one lymph node if one lymph node cannot be punctured, another lymph node will be chosen. Even if tissue-extraction out of a lymph node via cryoprobe fails once to several times, overall no more than 4 attempts for cryobiopsy will be done

DEVICE

Cryobiopsy lymphnode group 3 sec

Included patients receive transbronchial access with EBUS needle (19, 21 or 22 gauge needle) Hereafter, three times EBUS-TBNA followed by four EBUS-guided-CBs with a 1.1mm cryoprobe will be performed. Included patients are 1:1 randomized to receive CB with cryoprobe activated for either 3 sec of freezing time (group "3sec") or 6 sec. of freezing time (group "6sec") before the biopsy together with the whole EBUS bronchoscope is extracted. The EBUS-guided CB will be conducted four times in each group. Aiming access to one lymph node if one lymph node cannot be punctured, another lymph node will be chosen. Even if tissue-extraction out of a lymph node via cryoprobe fails once to several times, overall no more than 4 attempts for cryobiopsy will be done

Locations (1)

Jürgen Hetzel

Basel, Switzerland