EBUS Guided Cryobiopsies With Ultrathin Cryoprobe in Patients With Peripheral Pulmonary Nodules - a Feasibility Study

Transbronchial Cryobiopsy Clinical Trial

Official title:

EBUS Guided Cryobiopsies With Ultrathin Cryoprobe in Patients With Peripheral Pulmonary Nodules - a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04471324
• Other study ID #: Cryo SPN 1.1 trial
• Status: Completed
• Phase: N/A
• Start date: March 31, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: Thoraxklinik-Heidelberg gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The standard procedure in the diagnosis of peripheral round foci is bronchoscopy with transbronchial forceps biopsy (TBB). Despite the simultaneous application of X-ray fluoroscopy, the diagnostic value of this method depends strongly on the size, location and relationship of the foci to the airways as well as their radiological representability. By inserting radial 20 MHz ultrasound probes through the working channel of a flexible bronchoscope into the periphery of the lung, the detection of peripheral foci can be improved. By simultaneously using a virtual bronchoscopy with an ultra-thin bronchoscope, even smaller round foci in the periphery of the lung can be detected. For some years now, tension-resistant cryoprobes have been used for transbronchial biopsy. Here, especially in lesions that can only be reached endoscopically tangentially, advantages have been shown over forceps biopsy. Much larger tissue samples can be obtained without increasing the complication rate. Studies showed that the combination of the EBUS navigation technique with the cryobiopsy procedure is feasible and safe in the endoscopic diagnosis of peripheral lung tumors. This study investigates to what extent the combination of an ultra-thin cryoprobe with an ultra-thin bronchoscope together with the radial EBUS can further improve the diagnosis. This study is a non-randomized pilot study to prove the feasibility of this procedure. The EBUS probe and the bronchoscope are CE certified for this application. The study will be conducted as a monocentric study at the Thorax Clinic at Heidelberg University Hospital.

A total of 30 patients with an indication for transbronchial biopsy will be prospectively included. All patients will be examined according to the clinical standard. After a freezing time of 3-7 seconds, the probe together with the bronchoscope will be extracted and the sample will be defrosted in a water-filled sample vial. Up to 4 biopsies will be taken depending on the investigator's assessment. The samples will be collected separately and the order of the biopsies will be recorded. The primary endpoint is the feasibility of the procedure. Secondary endpoints are safety, diagnostic hit rate, biopsy size and quality and success rate depending on the position of the EBUS probe (tangential or central).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Single or multiple peripheral pulmonary round foci in CT

• signed patient information

Exclusion Criteria:

• severe co-mornidity

• no signed patien information

• contraindication for intervention

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Transbronchial Cryobiopsy

Intervention

Device:
• EBUS cryo probe
patients receive a transbronchial cryo biopsy with the EBUS cryo probe from ERBE and an ultra thin bronchoskope

Locations

Country	Name	City	State
Germany	Thoraxklinik Universitaetsmedizin	Heidelberg	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
Thoraxklinik-Heidelberg gGmbH	Erbe Elektromedizin GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the procedure - assessed by diagnosis agreement within the multidisciplinary team discussion	Pathological assessment of biopsies for ILD diagnosis	Day 1
Secondary	Bleeding time in seconds	Assessed by using a stop watch and entering data into a questionnaire	Day 1 until Day 2
Secondary	Size of biopsies	Planimetry	Day 1
Secondary	Quality of biopsies	artefact-free biopsies	Day 1
Secondary	Exacerbation rate	Assessment of exacerbations until 4 weeks after biopsy	4 weeks after biopsy