Endobronchial Ultrasound Clinical Trial
Official title:
Endobronchial Ultrasound Image Features in the Diagnosis of Peripheral Pulmonary Lesions
The study is aimed to evaluate the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of endobronchial ultrasound (EBUS) image features in diagnosing peripheral pulmonary lesions (PPLs).
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients who are older than 18 year-old. 2. Chest CT shows PPLs suspected to be malignant that need to be confirmed by pathology. The lesion is surrounded by lung parenchyma and invisible in standard bronchoscopy. 3. Patients who agree to undergo bronchoscopy without any contraindications. 4. Patients who have good compliance and sign informed consent. Exclusion Criteria: 1. Absence of bronchus leading to or adjacent to the lesion from CT scan. 2. Refusal of participation. 3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy. 4. Presence of concomitant endobronchial lesion during the bronchoscopy procedure |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Shanghai Chest Hospital |
Chao TY, Lie CH, Chung YH, Wang JL, Wang YH, Lin MC. Differentiating peripheral pulmonary lesions based on images of endobronchial ultrasonography. Chest. 2006 Oct;130(4):1191-7. — View Citation
Izumo T, Sasada S, Chavez C, Matsumoto Y, Tsuchida T. Radial endobronchial ultrasound images for ground-glass opacity pulmonary lesions. Eur Respir J. 2015 Jun;45(6):1661-8. doi: 10.1183/09031936.00167914. Epub 2015 Jan 8. — View Citation
Kurimoto N, Murayama M, Yoshioka S, Nishisaka T. Analysis of the internal structure of peripheral pulmonary lesions using endobronchial ultrasonography. Chest. 2002 Dec;122(6):1887-94. — View Citation
Travis WD, Rekhtman N, Riley GJ, Geisinger KR, Asamura H, Brambilla E, Garg K, Hirsch FR, Noguchi M, Powell CA, Rusch VW, Scagliotti G, Yatabe Y. Pathologic diagnosis of advanced lung cancer based on small biopsies and cytology: a paradigm shift. J Thorac Oncol. 2010 Apr;5(4):411-4. doi: 10.1097/JTO.0b013e3181d57f6e. — View Citation
Yasufuku K. Current clinical applications of endobronchial ultrasound. Expert Rev Respir Med. 2010 Aug;4(4):491-8. doi: 10.1586/ers.10.39. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The diagnostic value of EBUS image features | The diagnostic value includes sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate. | one year | |
Secondary | EBUS image features of adenocarcinoma | Making invasive EBUS image features of adenocarcinoma and non-invasive adenocarcinoma | one year |
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