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

Sponsor

Thoraxklinik-Heidelberg gGmbH (Other)

Overall Status

Completed

CT.gov ID

NCT04471324

Collaborator

Erbe Elektromedizin GmbH (Industry)

Enrollment

Location

Arm

Actual Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Transbronchial Cryobiopsy	Device: EBUS cryo probe	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 31, 2020

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EBUS cryo probe Patients receive a transbronchial cryobiopsy using an eBUS cryo probe	Device: EBUS cryo probe patients receive a transbronchial cryo biopsy with the EBUS cryo probe from ERBE and an ultra thin bronchoskope

Arm

Intervention/Treatment

Experimental: EBUS cryo probe

Patients receive a transbronchial cryobiopsy using an eBUS cryo probe

Device: EBUS cryo probe

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

Outcome Measures

Primary Outcome Measures

Feasibility of the procedure - assessed by diagnosis agreement within the multidisciplinary team discussion [Day 1]
Pathological assessment of biopsies for ILD diagnosis

Secondary Outcome Measures

Bleeding time in seconds [Day 1 until Day 2]
Assessed by using a stop watch and entering data into a questionnaire
Size of biopsies [Day 1]
Planimetry
Quality of biopsies [Day 1]
artefact-free biopsies
Exacerbation rate [4 weeks after biopsy]
Assessment of exacerbations until 4 weeks after biopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thoraxklinik Universitaetsmedizin	Heidelberg	Baden-Wuerttemberg	Germany	69126

Sponsors and Collaborators

Thoraxklinik-Heidelberg gGmbH
Erbe Elektromedizin GmbH

Investigators

Principal Investigator: Ralf Eberhardt, Prof. Dr. med., Thoraxklinik Universitaetsklinikum Heidelberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thoraxklinik-Heidelberg gGmbH

ClinicalTrials.gov Identifier:

NCT04471324

Other Study ID Numbers:

Cryo SPN 1.1 trial

First Posted:

Jul 15, 2020

Last Update Posted:

Oct 12, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Multiple Pulmonary Nodules

Study Results

No Results Posted as of Oct 12, 2020