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Completed

NCT Number: NCT05257382

Added Value of Cone Beam CT Guidance to Electromagnetic Navigation Bronchoscopy for the Diagnosis of Pulmonary Nodule.

A monocentric prospective and randomized trial aiming to compare the diagnostic yield and safety of electromagnetical-guided bronchoscopy (ENB) procedures coupled to trans-bronchial lung cryobiopsies for the diagnosis of pulmonary nodule when performed either in a "standard" bronchoscopy suite or in a hybrid room with CBCT guidance and the use of the CrossCountry technique as required.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pulmonary Disease Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Erasme

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pulmonary nodule of maximum 30mm of largest diameter
  • Nodules can be either solid or subsolid (including GGO) without evidence of loco-regional or distant metastasis that could be biopsied, and no evidence for an infectious underlying disease.
  • A multidisciplinary discussion is performed for each case before considering its inclusion in the study in order to validate the indication of ENB-guided biopsy. Of note, any other endoscopic or trans-thoracic procedure should be tried before considering ENB if it could achieve the diagnosis according to the investigator's judgment.

Exclusion criteria

  • Patient eligible for a direct surgical resection of the nodule
  • Other exclusion criteria are a higher risk of bleeding (platelets count lower than 80,000/mm³, a systolic pulmonary arterial pressure (sPAP) higher than 45 mmHg at transthoracic ultrasonography, prothrombin time international normalized ratio - INR >1.5, activated partial thromboplastin time - APTT >35, uninterrupted anti-coagulant/anti-aggregant therapy), and the presence of any contraindication to general anesthesia as determined by the principal investigator (significant cardiac comorbidities, hypercapnia, severe hypoxia...).

No strict limits for inclusion were applied regarding diffusing capacity for carbon monoxide (DLCO), forced vital capacity (FVC), and forced expiratory volume in 1 second (FEV1).

Treatment and study plan

ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy

Procedure

After having performed the ENB procedure to reach the identified lung lesion, biopsies will be performed (six forceps trans-bronchial biopsies and one trans-bronchial lung cryobiopsy)

Primary outcomes

  1. Diagnostic yield

    Time frame: Through study completion, an average of 1 year

    The primary outcome will be the comparison of the diagnostic yield obtained when ENB procedures will be performed on either the "classical " endoscopic suite or in the CBCT suite

Secondary outcomes

  1. Rate of pneumothorax

    Time frame: up to 1 month after the procedure

    On the basis of control chest Xray performs after the endoscopic intervention. The need of chest drainage will also be recorded.

  2. Rate of bleeding

    Time frame: up to 1 month after the procedure

    Bleeding will be scored as follows: score 0, when no bleeding occurs; score 1, when bleeding stops within five minutes either spontaneously or by inflation of a Fogarty balloon; score 2, when bleeding is prolonged more than five minutes or needs cold saline instillation; and score 3, when bleeding requires embolization, selective bronchial intubation, transfusion, admission in the intensive care unit, results in prolonged hospital stay, or patient's death.

  3. Duration of the interventions

    Time frame: Up to one day after the procedure

    The total duration of the bronchoscope intervention will be recorded.

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

A Randomized Controlled Study Evaluating the Added Value of an Hybrid Room Equipped With a Cone Beam CT (CBCT) to Electromagnetic Navigation Bronchoscopy (ENB) for the Diagnosis of Pulmonary Nodule.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 25, 2022
Registry last updated
Jul 27, 2022

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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