Diagnosis of Peripheral Lung Nodules Using Cryobiopsy

University of Zurich54 enrolled

Overview

Since the traditional radial endobronchial ultrasound guided biopsy technique of solitary pulmonary nodules using the forceps has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryobrobe

This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different outer diameters. Included patients are 1:1 randomized to receive forceps biopsy following cryobiopsy with a 1.1mm or 1.7mm cryoprobe.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Lung; Node

Interventions

Forceps biopsy and cryobiopsyPROCEDURE

Once the nodule is visualized by radial EBUS, the position of the probe in relation to the lesion is noted. Routinely, forceps biopsy and cryobiopsy are used serially in each patient within the same session.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Solitary pulmonary nodule with indication of bronchoscopic diagnostic approach * 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, communi-cation barriers) * Contraindication against bronchoscopy (e.g. co-morbidities) * INR \> 2 or Thrombocytes \< 50000 * Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy * Anticoagulation with NOAK within 48 hours before biopsy * Moderate or severe pulmonary hypertension (mPAP \> 30 mmHg, RV/RA \>30 mmHg) * Tumors suspicious of endobronchial growth

Locations (1)

University hospital Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Diagnostic yield

The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage

Time frame: up to 1 month

Secondary Outcomes

Size of harvested tissue in millimeter

The biopsies are assessed for total size in millimeter

Time frame: up to 1 month

Size of malign tissue in millimeter

The biopsies are assessed for size of malign tissue in milimeter

Time frame: up to 1 month

Occurrence of bleeding events

Time frame: up to 1 month

Size of artifact-free alvoelar space in percentage

Time frame: up to 1 month

Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)

Lesion orientation with regards of the radial endobronchial ultrasound probe

Time frame: 1 day

Occurence of pneumothorax

Detection with X-ray

Time frame: up to 1 month

Data from ClinicalTrials.gov

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