Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2016-06-30
2017-09-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Endobronchial Ultrasound
Patients undergoing EBUS with TransBronchial Needle Aspiration will be invited to enroll on the day of their procedure. Once informed consent is obtained, the surgeon will assess the sonographic criteria, take pictures, and biopsy every lymph node of interest. All three elements of this assessment will need to be completed for a specimen to be included in the study. After the procedure, the operating surgeon will fill the Lymph Node Assessment questionnaire, assign an aggregate score to every lymph node specimen, and attach the pictures to the form. Pictures from every specimen will stored electronically to be reviewed and secondarily rated by a second blinded surgeon. Patient involvement in the study ends at the completion of the planned procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Toronto General Hospital
OTHER
Vancouver General Hospital
OTHER
McMaster University
OTHER
Responsible Party
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Principal Investigators
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Wael C Hanna, MDCM MBA
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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References
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American College of Chest Physicians; Health and Science Policy Committee. Diagnosis and management of lung cancer: ACCP evidence-based guidelines. American College of Chest Physicians. Chest. 2003 Jan;123(1 Suppl):D-G, 1S-337S. No abstract available.
Hanna WC, Yasufuku K. Bronchoscopic staging of lung cancer. Ther Adv Respir Dis. 2013 Apr;7(2):111-8. doi: 10.1177/1753465812468041. Epub 2012 Dec 20.
Schmid-Bindert G, Jiang H, Kahler G, Saur J, Henzler T, Wang H, Ren S, Zhou C, Pilz LR. Predicting malignancy in mediastinal lymph nodes by endobronchial ultrasound: a new ultrasound scoring system. Respirology. 2012 Nov;17(8):1190-8. doi: 10.1111/j.1440-1843.2012.02223.x.
Shafiek H, Fiorentino F, Peralta AD, Serra E, Esteban B, Martinez R, Noguera MA, Moyano P, Sala E, Sauleda J, Cosio BG. Real-time prediction of mediastinal lymph node malignancy by endobronchial ultrasound. Arch Bronconeumol. 2014 Jun;50(6):228-34. doi: 10.1016/j.arbres.2013.12.002. Epub 2014 Feb 8. English, Spanish.
Wang L, Wu W, Hu Y, Teng J, Zhong R, Han B, Sun J. Sonographic Features of Endobronchial Ultrasonography Predict Intrathoracic Lymph Node Metastasis in Lung Cancer Patients. Ann Thorac Surg. 2015 Oct;100(4):1203-9. doi: 10.1016/j.athoracsur.2015.04.143. Epub 2015 Jul 28.
El-Sherief AH, Lau CT, Wu CC, Drake RL, Abbott GF, Rice TW. International association for the study of lung cancer (IASLC) lymph node map: radiologic review with CT illustration. Radiographics. 2014 Oct;34(6):1680-91. doi: 10.1148/rg.346130097.
Other Identifiers
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EBUS_ScoreValidation
Identifier Type: -
Identifier Source: org_study_id
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