Bronchoscopic Diagnosis of Peripheral Lung Nodules Using Endobronchial Ultrasound Guided Forceps and Cryobiopsy. A Randomized-controlled Trial

University of Zurich1 site in 1 country54 target enrollmentApril 1, 2021

ConditionsLung; Node

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lung; Node
Sponsor: University of Zurich
Enrollment: 54
Locations: 1
Primary Endpoint: Diagnostic yield
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2021

End Date

May 30, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Zurich

Responsible Party

Principal Investigator

Carolin Steinack

Principal Investigator

University of Zurich

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diagnostic yield

Time Frame: up to 1 month

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

Secondary Outcomes

Size of artifact-free alvoelar space in percentage(up to 1 month)
Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)(1 day)
Size of harvested tissue in millimeter(up to 1 month)
Size of malign tissue in millimeter(up to 1 month)
Occurrence of bleeding events(up to 1 month)
Occurence of pneumothorax(up to 1 month)