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

University of Zurich (UZH)

Status: Completed

Conditions: Lung; Node

Treatments: Procedure: Forceps biopsy and cryobiopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04885595

2021-00323

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Forceps-Cryo 1.1 mm

Active Comparator group

Description:

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

Treatment:

Procedure: Forceps biopsy and cryobiopsy

Forceps-Cryo 1.7 mm

Active Comparator group

Description:

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

Treatment:

Procedure: Forceps biopsy and cryobiopsy