Diagnosis of Peripheral Lung Nodules Using Cryobiopsy

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Lung; Node

Intervention / Treatment
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* Procedure: Forceps biopsy and cryobiopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Forceps-Cryo 1.1 mm<br>Forceps biopsy following cryobiopsy with a 1.1mm cryoprobe are obtained within the same session | Procedure: Forceps biopsy and cryobiopsy<br>* 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.<br>|
| Active Comparator: Forceps-Cryo 1.7 mm<br>Forceps biopsy following cryobiopsy with a 1.7mm cryoprobe are obtained within the same session | Procedure: Forceps biopsy and cryobiopsy<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryobiopsy