Diagnosis of Peripheral Lung Nodules Using Cryobiopsy

Lung; Node Clinical Trial

— Cryo-Nodule  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04885595
• Other study ID #: 2021-00323
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 30, 2022
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung; Node

Intervention

Procedure:
• Forceps biopsy and cryobiopsy
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.

Locations

Country	Name	City	State
Switzerland	University hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage	up to 1 month
Secondary	Size of harvested tissue in millimeter	The biopsies are assessed for total size in millimeter	up to 1 month
Secondary	Size of malign tissue in millimeter	The biopsies are assessed for size of malign tissue in milimeter	up to 1 month
Secondary	Occurrence of bleeding events	Occurrence of bleeding events	up to 1 month
Secondary	Size of artifact-free alvoelar space in percentage	Size of artifact-free alvoelar space in percentage	up to 1 month
Secondary	Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)	Lesion orientation with regards of the radial endobronchial ultrasound probe	1 day
Secondary	Occurence of pneumothorax	Detection with X-ray	up to 1 month