Clinical trial NCT03274609: CT-controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Augmented Fluoroscopy Bronchoscopic Navigation Based Diagnostic Yield
Official title: CT-controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Augmented Fluoroscopy Bronchoscopic Navigation Based Diagnostic Yield
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung diseases
cancer
Interventional pulmonology
peripheral nodule
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of patients diagnosed with peripheral pulmonary lesion(s) and an indication to obtain a tissue sample(s) following current conventional procedure work-up. In all patients, preprocedural imaging (including CT and/or PET-CT findings) following conventional work-up is available. Case selection for the clinical indication to perform a peripheral pulmonary biopsy (non-surgical and/or surgical) will follow current local clinical practice, multidisciplinary tumor board decisions and is in accordance to the latest British Thoracic Society guidelines (British Thoracic Society Pulmonary Nodule Guideline Development Group, 2015). Patients are eligible after informed consent is obtained and when direct contra-indications for the endobronchial procedure are absent.

Brief summary: In this exploratory adaptive clinical trial the investigators will examine the diagnostic yield of a combination of commercially available imaging and navigation techniques for reaching peripheral lung lesions. The two investigated techniques will herein be the rEBUS imaging modality combined with augmented fluoroscopy based virtual bronchoscopy navigation. Confirmation of reaching the lung lesion will be by means of CT (fluoroscopic) imaging. Rapid On-Site Evaluation (ROSE) of cytopathology will be used for obtaing a per-procedural outcome on tissue biopsy representativeness. The study will replace the current conventional standard TBB procedure (fluoroscopy and rEBUS guided bronchoscopy) in the endoscopy suite. Consecutive patients will be included on the MITeC hybrid operating room (needed to monitor patient safety and CT availability). All data will be prospectively collected. In case tissue biopsy is found to be malignant or benign, it will be termed representative. In case tissue biopsy is found to be non-representative (=blood, anatomical lung tissue, unreachable), conventional follow-up of CT guided TTNA, follow-up monitoring and/or surgical biopsy will serve as golden standard for obtaining tissue diagnosis. For verification of reaching the target lesion, another study parameter of interest, (cb)CT imaging will be performed for verification that instruments are within the nodule (per-procedurally available).

Detailed description: Lung cancer is one of the leading most frequent types of cancer and is the most lethal malignancy in the Netherlands. Mortality is high due to its advanced stage disease at diagnosis. To improve survival current guidelines are moving towards CT-screening of the high risk population. These CT-scans detect numerous nodules and rapidly increase the demand for minimal invasive accurate and safe diagnostic procedures.

The historically available and current first diagnostic procedure in the work-up of PPLs is fluoroscopy guided Trans Bronchial Biopsy (TBB) despite its low pooled yield of 31.1%. When the above transbronchial technique does not provide an unambiguous outcome, an additional and more invasive diagnostic work-up remains indicated. To exclude the possibility of missing malignancies, trans thoracic needle aspiration is first indicated. If deemed inaccessible, surgical biopsy may be alternatively indicated depending on patient risk of malignancy. Ideally, a transbronchial approach having high diagnostic accuracy would overcome the need of this sequential increasingly invasive diagnostic and consecutive treatment approach. Newer pilot studies now hypothesize that combining multiple new endobronchial modalities might provide a solution in preventing more invasive additional diagnostic staging, reporting diagnostic yields exceeding 70%. When an accurate and certain transbronchial diagnosis by combining multiple techniques can indeed be provided. We will study a combination of new advanced modalities for diagnosis of peripheral nodules endobronchially. The aim of this study is to determine diagnostic yield, cost-effectiveness, safety, and, to collect data for developing diagnostic algorithms to further cost-effectively increase yield, reduce complication rate and determine a future platform for clinical implementation.

Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* ASA physical status 1-3.
* Age 18 years or older.
* A pulmonary lesion (i.e. a focal, rounded opacity mostly surrounded by aerated lung or a ground glass opacity or part- or sub-solid lesion) with an indication for diagnostic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Bleeding disorders.
* Less than 18 years old.
* Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines, clopidrogel, analogs, or, NOAC's).
* Known allergy for lidocaine.
* Uncontrolled pulmonary hypertension.
* Recent and/or uncontrolled cardiac disease.
* Compromised upper airway (e.g. concomitant head and neck cancer or central airway stenosis for any reason such that endobronchial access is considered unsafe).
* ASA classification greater than or equal to 4 (unfit for performing non-surgical biopsy).
* Pregnancy.
* Inability to consent.

Primary outcomes:
measure: number of patients with an adequate diagnosis (=diagnostic yield)
timeFrame: 0-12 months
Secondary outcomes:
measure: number of patients with (S)AE's related to the procedure
timeFrame: 0-12 months
measure: cost-effectiveness
timeFrame: 0-12 months
measure: radiation exposure
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Study coordinator
name: Linda Garms
role: STUDY_CHAIR
affiliation: Pulmonary diseases
name: Erik van der Heijden, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmonary diseases / Radiology
name: Roel Verhoeven, Msc
role: STUDY_CHAIR
References: