Diagnosis of Peripheral Lung Nodules Using Cryobiopsy

Not Applicable

Completed

• Conditions: Lung; Node

• Registration Number: NCT04885595
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-05-08
• Study First Posted: 2021-05-13
• Primary Completion: 2023-04-15
• Study Completion: 2023-05-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	up to 1 month	The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage

Secondary Outcome Measures

Name	Time	Method
Size of artifact-free alvoelar space in percentage	up to 1 month	Size of artifact-free alvoelar space in percentage
Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)	1 day	Lesion orientation with regards of the radial endobronchial ultrasound probe
Size of harvested tissue in millimeter	up to 1 month	The biopsies are assessed for total size in millimeter
Size of malign tissue in millimeter	up to 1 month	The biopsies are assessed for size of malign tissue in milimeter
Occurrence of bleeding events	up to 1 month	Occurrence of bleeding events
Occurence of pneumothorax	up to 1 month	Detection with X-ray

Trial Locations

Locations (1)

University hospital Zurich; 🇨🇭 Zurich, Switzerland