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

NCT04471324 | Completed

• 1 other identifier: Cryo SPN 1.1 trial
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Transbronchial Cryobiopsy

Outcome Measures

Primary Outcomes (1)

• Feasibility of the procedure - assessed by diagnosis agreement within the multidisciplinary team discussion

  Pathological assessment of biopsies for ILD diagnosis

  Day 1

Secondary Outcomes (4)

• Bleeding time in seconds

  Day 1 until Day 2

• Size of biopsies

  Day 1

• Quality of biopsies

  Day 1

• Exacerbation rate

  4 weeks after biopsy

Study Arms (1)

EBUS cryo probe

EXPERIMENTAL

Patients receive a transbronchial cryobiopsy using an eBUS cryo probe

Device: EBUS cryo probe

Interventions

EBUS cryo probe DEVICE

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

EBUS cryo probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single or multiple peripheral pulmonary round foci in CT
• signed patient information

You may not qualify if:

• severe co-mornidity
• no signed patien information
• contraindication for intervention

Sponsors & Collaborators

• Thoraxklinik-Heidelberg gGmbH: lead
• Erbe Elektromedizin GmbH: collaborator

Study Sites (1)

Thoraxklinik Universitaetsmedizin

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Study Officials

• Ralf Eberhardt, Prof. Dr. med.

  Thoraxklinik Universitaetsklinikum Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 15, 2020
• Study Start: March 31, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)