CT‐Controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Electromagnetic Navigation Based Diagnostic Yield (CONTROL-E)
|ClinicalTrials.gov Identifier: NCT03355586|
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment|
|Lung Cancer||Combination Product: Electromagnetic navigation|
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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||CT‐Controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Electromagnetic Navigation Based Diagnostic Yield|
|Actual Study Start Date :||December 21, 2017|
|Actual Primary Completion Date :||January 1, 2019|
|Actual Study Completion Date :||November 1, 2019|
Suspected lung cancer
These will be subjected to a combined approach of modalities with the main intervention being electromagnetic navigation.
Combination Product: Electromagnetic navigation
Electromagnetic navigation combined with use of radial EBUS probe and Rapid On Site Evaluation of Histology for diagnosis of peripheral pulmonary nodules.Controlled by cone beam CT.
- number of patients with an adequate diagnosis (= diagnostic yield) [ Time Frame: 0-12 months ]diagnosis will consist of benign, malign or non-representative (=blood, anatomical lung tissue, unreachable)
- number of patients with (S)AE's related to the procedure [ Time Frame: 0-12 months ]minor bleeding and pneumothoraces are reported
- cost-effectiveness [ Time Frame: 0-12 months ]the study procedures will be compared against the conventional diagnostic TBB work-up
- radiation exposure [ Time Frame: 0-12 months ]compared against conventional TBB and consecutive TTNA procedure
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355586
|Nijmegen, Gelderland, Netherlands, 6525GA|
|Study Chair:||Linda Garms||study coordinator|
|Principal Investigator:||Erik van der Heijden, MD PhD||Pulmonary diseases|
|Study Chair:||Roel Verhoeven, Msc||Pulmonary Diseases / Radiology|