Lung Cancer Clinical Trial
— NEBULAOfficial title:
The Efficacy of Combining Endoscopic Modalities for the Diagnosis of Solitary Pulmonary Lesions
Lung cancer is the primary cause of cancer related deaths in Denmark. In order to improve the prognosis diagnosis in earlier stages are needed. This will however require improved sampling techniques from very small lung lesions. One method involves the use of a radial ultrasound probe inserted in the working channel of the bronchoscope, to more accurately identify the lung lesions before sampling them (rEBUS). The other method involves the use of electromagnetic navigation bronchoscopy (ENB) to guide the operator to the lung lesion. This study aims to determine whether a combination of rEBUS and ENB is superior to ENB alone in biopsy sampling. The study will be conducted as a non-blinded RCT. Furthermore, we will make an estimate of the hospital costs of the entire diagnostic work up for lung cancer when combining ENB and rEBUS compared to ENB alone.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Examination for lung cancer - Peripheral lung lesion or lung nodule surrounded by normal lung parenchyma - Written and orally informed consent Exclusion Criteria: - Patient has medical devices in which ENB is contraindicated (e.g. implanted pacemaker or defibrillator) - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Denmark | Departement of respiratory medicin | Odense | Region Of Southern Denmark |
Lead Sponsor | Collaborator |
---|---|
Amanda Dandanell Juul |
Denmark,
Ali MS, Trick W, Mba BI, Mohananey D, Sethi J, Musani AI. Radial endobronchial ultrasound for the diagnosis of peripheral pulmonary lesions: A systematic review and meta-analysis. Respirology. 2017 Apr;22(3):443-453. doi: 10.1111/resp.12980. Epub 2017 Feb 8. — View Citation
Brownback KR, Quijano F, Latham HE, Simpson SQ. Electromagnetic navigational bronchoscopy in the diagnosis of lung lesions. J Bronchology Interv Pulmonol. 2012 Apr;19(2):91-7. doi: 10.1097/LBR.0b013e31824dd9a1. — View Citation
Eberhardt R, Anantham D, Ernst A, Feller-Kopman D, Herth F. Multimodality bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. Am J Respir Crit Care Med. 2007 Jul 1;176(1):36-41. doi: 10.1164/rccm.200612-1866OC. Epub 2007 Mar 22. — View Citation
Evison M, Crosbie PA, Morris J, Martin J, Barber PV, Booton R. Can computed tomography characteristics predict outcomes in patients undergoing radial endobronchial ultrasound-guided biopsy of peripheral lung lesions? J Thorac Oncol. 2014 Sep;9(9):1393-7. doi: 10.1097/JTO.0000000000000249. — View Citation
Haas AR, Vachani A, Sterman DH. Advances in diagnostic bronchoscopy. Am J Respir Crit Care Med. 2010 Sep 1;182(5):589-97. doi: 10.1164/rccm.201002-0186CI. Epub 2010 Apr 8. — View Citation
Herth FJ, Eberhardt R, Becker HD, Ernst A. Endobronchial ultrasound-guided transbronchial lung biopsy in fluoroscopically invisible solitary pulmonary nodules: a prospective trial. Chest. 2006 Jan;129(1):147-50. doi: 10.1378/chest.129.1.147. — View Citation
Khan KA, Nardelli P, Jaeger A, O'Shea C, Cantillon-Murphy P, Kennedy MP. Navigational Bronchoscopy for Early Lung Cancer: A Road to Therapy. Adv Ther. 2016 Apr;33(4):580-96. doi: 10.1007/s12325-016-0319-4. Epub 2016 Mar 22. — View Citation
Munoz-Largacha JA, Litle VR, Fernando HC. Navigation bronchoscopy for diagnosis and small nodule location. J Thorac Dis. 2017 Mar;9(Suppl 2):S98-S103. doi: 10.21037/jtd.2017.01.57. — View Citation
Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003 Jan;123(1 Suppl):115S-128S. doi: 10.1378/chest.123.1_suppl.115s. — View Citation
Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764. — View Citation
Zhang W, Chen S, Dong X, Lei P. Meta-analysis of the diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules. J Thorac Dis. 2015 May;7(5):799-809. doi: 10.3978/j.issn.2072-1439.2015.04.46. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total diagnostic yield | Total diagnostic yield, being defined as a tissue biopsy allowing a definite diagnosis of either a malignant or benign condition in the lung in proportion to the total number of procedures performed. | 6 months | |
Secondary | Malignant diagnostic yield | Diagnostic yield of malignant conditions, being defined as a tissue biopsy allowing a definite diagnosis of a malignant condition in the lung | 6 months | |
Secondary | Non-malignant diagnostic yield | Diagnostic yield of non-malignant conditions, being defined as a tissue biopsy allowing a definite diagnosis of a benign condition in the lung | 6 months | |
Secondary | Complications | Total proportion of patients with procedure complications | 1 week | |
Secondary | Severe complications | Total proportion of patients with severe procedure complications | 1 week | |
Secondary | Ready to treat | Time from referral to "ready to treat" | 7 months | |
Secondary | Discomfort | Patient reported procedure discomfort during the endoscopic procedure. Reported in a questionnaire efter the procedure. | 2 weeks | |
Secondary | Patient satisfaction | Patient reported procedure satisfaction. Reported in a questionnaire after the procedure in a scale from 1 -10. | 2 weeks | |
Secondary | Procedure time | Procedure time differens between the two arms | 1 week | |
Secondary | Procedure costs | Differens in procedure cost for the two arms, reported in daniske kroner or converted to euro for publications | 2 years | |
Secondary | Entire work-up costs | Hospital costs of the entire diagnostic workup incl. admissions and expenses for treating adverse events from referral to end of "cancer package". Reported in danish kroner or converted to euro for publication. | 2 years |
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