Cryo-Nodule: Diagnosis of Peripheral Lung Nodules Using Cryobiopsy

Sponsor

University of Zurich (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04885595

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lung; Node	Procedure: Forceps biopsy and cryobiopsy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Apr 7, 2021

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Forceps-Cryo 1.1 mm Forceps biopsy following cryobiopsy with a 1.1mm cryoprobe are obtained within the same session	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.
Active Comparator: Forceps-Cryo 1.7 mm Forceps biopsy following cryobiopsy with a 1.7mm cryoprobe are obtained within the same session	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.

Arm

Intervention/Treatment

Active Comparator: Forceps-Cryo 1.1 mm

Forceps biopsy following cryobiopsy with a 1.1mm cryoprobe are obtained within the same session

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.

Active Comparator: Forceps-Cryo 1.7 mm

Forceps biopsy following cryobiopsy with a 1.7mm cryoprobe are obtained within the same session

Procedure: Forceps biopsy and cryobiopsy

Outcome Measures

Primary Outcome Measures

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

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
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
Occurence of pneumothorax [up to 1 month]
Detection with X-ray

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital Zurich	Zurich		Switzerland	8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator: Carolin Steinack, MD, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carolin Steinack, Principal Investigator, University of Zurich

ClinicalTrials.gov Identifier:

NCT04885595

Other Study ID Numbers:

2021-00323

First Posted:

May 13, 2021

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

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:

Keywords provided by Carolin Steinack, Principal Investigator, University of Zurich

Cryobiopsy

Study Results

No Results Posted as of Jul 13, 2022