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Completed

NCT Number: NCT04885595

Diagnosis of Peripheral Lung Nodules Using Cryobiopsy

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

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Key information

Conditions

Lung; Node

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forceps biopsy and cryobiopsy

Procedure

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.

Primary outcomes

  1. Diagnostic yield

    Time frame: up to 1 month

    The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage

Secondary outcomes

  1. Size of harvested tissue in millimeter

    Time frame: up to 1 month

    The biopsies are assessed for total size in millimeter

  2. Size of malign tissue in millimeter

    Time frame: up to 1 month

    The biopsies are assessed for size of malign tissue in milimeter

  3. Occurrence of bleeding events

    Time frame: up to 1 month

    Occurrence of bleeding events

  4. Size of artifact-free alvoelar space in percentage

    Time frame: up to 1 month

    Size of artifact-free alvoelar space in percentage

  5. Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)

    Time frame: 1 day

    Lesion orientation with regards of the radial endobronchial ultrasound probe

  6. Occurence of pneumothorax

    Time frame: up to 1 month

    Detection with X-ray

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: Cryo-Nodule

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 13, 2021
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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