Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

University of Zurich136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

136

Interventions

Cryobiopsy of lymph nodes group 6 secDEVICE

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

Cryobiopsy lymphnode group 3 secDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least one mediastinal lesion or hilar 1 cm or longer in the short axis requiring diagnostic bronchoscopy * Age between 18 and 90 years * Written informed consent after participant's information Exclusion Criteria: * Age \< 18 and \> 90 years * Lacking ability to form an informed consent (including impaired judgement, communication barriers) * Contraindication against bronchoscopy (e.g. co-morbidities) * Mediastinal abscess or cyst * Extraordinary blood supply of the lesion visualized by EBUS bronchoscope * INR \> 1.5 or Thrombocytes \< 100 G/l * Clopidogrel or other new antiplatelet drugs within 7 days before biopsy (salicylic acid alone allowed) * Anticoagulation with NOAC within 48 hours before biopsy * Pulmonary lesions suspicious of lung carcinoma

Outcomes

Primary Outcomes

Diagnostic yield

Primary outcome measure is diagnostic yield according to the ATS consensus 2024 of EBUS-guided CB using two different freezing times (3sec./6.sec.).

Time frame: from date of randomization to the time of the first documented results, assessed up to 100 weeks

Secondary Outcomes

overall rate of suitability for histopathological examination

Time frame: from the date of randomization to the time of the first documented results, assessed up to 100 weeks

the size of the harvested tissue (mm2)

Time frame: from date of randomization to the time of the first documented results, assessed up to 100 months

), isolated and cumulative diagnostic yield of the first, second, third and fourth cryobiopsy

Time frame: from date of randomization to the time of the first documented results, assessed up to100 weeks

time of the procedure