Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

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.

Conditions

• Lung Cancer (NSCLC)

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

Sponsors & Collaborators

• Aarau Cantonal Hospital (KSA)

  collaborator UNKNOWN

• Waid City Hospital, Zurich

  collaborator OTHER

• Kantonsspital Winterthur KSW

  collaborator OTHER

• Unispital Basel

  collaborator UNKNOWN

• Spital Uster AG, Uster, Switzerland

  collaborator UNKNOWN

• Clinique des Grangettes, Chêne-Bougeries

  collaborator UNKNOWN

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Réseau Hospitalier Neuchâtelois

  collaborator OTHER

• University of Lausanne Hospitals

  collaborator OTHER

• Cantonal Hospital of St. Gallen

  collaborator OTHER

• Ospedale Regionale Bellinzona e Valli

  collaborator OTHER

• HUG - Hôpitaux universitaires de Genève

  collaborator UNKNOWN

• Kantonsspital Chur, Switzerland

  collaborator UNKNOWN

• Hôpital du Valais

  collaborator OTHER

• University of Zurich

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-07

Primary Completion

2029-04-01

Completion

2029-12-31

Countries

• Switzerland

Study Locations