Diagnosis of Peripheral Lung Nodules Using Cryobiopsy (Cryo-Nodule)

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

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

Study Overview

• Status: Completed
• Conditions: Lung; Node
• Intervention / Treatment: Procedure: Forceps biopsy and cryobiopsy

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of harvested tissue in millimeter	The biopsies are assessed for total size in millimeter	up to 1 month
Size of malign tissue in millimeter	The biopsies are assessed for size of malign tissue in milimeter	up to 1 month
Occurrence of bleeding events	Occurrence of bleeding events	up to 1 month
Size of artifact-free alvoelar space in percentage	Size of artifact-free alvoelar space in percentage	up to 1 month
Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)	Lesion orientation with regards of the radial endobronchial ultrasound probe	1 day
Occurence of pneumothorax	Detection with X-ray	up to 1 month

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Carolin Steinack, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: May 8, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cryobiopsy
• Other Study ID Numbers: 2021-00323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No