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The aim of this study is to compare the performance of 22G-ProCore and 22G-Standard needle in diagnosis of mediastinal and hilar lymphadenopathy via EBUS-TBNA with the purpose to explore the optimal technique for obtaining diagnostic material.
EBUS-TBNA is an important minimally invasive tool for the diagnosis of mediastinal and hilar lymphadenopathy. The investigators will explore the performance of two kinds of needles and different methods to obtain tissues via EBUS-TBNA in the study. The study is designed as a prospective, single-center, randomized controlled trial, 600 patients will be expected to enroll in the study and randomly assigned to two groups, the 22G-ProCore group and the 22G-Standard group. The primary aim is to compare the diagnostic yields of the two types of needles. The secondary endpoint is to assess the quality of histologic specimen. Meanwhile, stylet slow-pull or negative suction techniques and different agitations (10, 20, 30 times) that each pass includes will be evaluated in the study as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 22G-ProCore Group | Experimental | The experimental group with 22G-ProCore needle is expected to enroll 300 patients. The 22G-ProCore needle has a 1.5mm long groove 2.5mm above the needle tip, which is expected to have the advantage of taking more biopsy tissues than the 22G-Standard needle. |
|
| 22G-Standard Group | Active Comparator | The control group of 22G-Standard needle is expected to include 300 patients, and there is no groove above the needle tip compared with 22G-ProCore needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 22G-ProCore Endobronchial Ultrasound Needle | Device | EchoTip ProcoreĀ® Endobronchial HD Ultrasound Biopsy Needle, COOK |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield of 22G-ProCore needle | Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained. | up to 6 months |
| Diagnostic yield of 22G-Standard needle | Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The quality of histologic specimen used by 22G-ProCore needle | The number and ratio of cellularity, blood contamination, and core-tissue acquisition. | up to 6 months |
| The quality of histologic specimen used by 22G-Standard needle |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield of aspiration techniques | Conventional EBUS-TBNA procedures involve use of 10mL negative suction aspiration techniques. A new aspiration method, the stylet slow-pull technique, involves slow withdrawal of the needle stylet to create minimum negative pressure. | up to 6 months |
| Diagnostic yield of different agitations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, PhD | Contact | +86-021-22200000 | 1511 | jysun1976@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun, MD,PhD | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25976686 | Background | Stamatis G. Staging of lung cancer: the role of noninvasive, minimally invasive and invasive techniques. Eur Respir J. 2015 Aug;46(2):521-31. doi: 10.1183/09031936.00126714. Epub 2015 May 14. | |
| 27755785 | Background | Sun J, Zhang J, Zhao H, Shen J, Gu A, Han B. Role of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of bronchogenic carcinoma: Experience of a single institution in China. Thorac Cancer. 2010 May;1(1):28-34. doi: 10.1111/j.1759-7714.2010.00010.x. |
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| 22G-Standard Endobronchial Ultrasound Needle | Device | EchoTipĀ® Ultra Endobronchial High Definition Ultrasound Needle, COOK |
|
The number and ratio of cellularity, blood contamination, and core-tissue acquisition.
| up to 6 months |
Agitation means needle moving 10 or 20 or 30 times back and forth in lymph nodes per pass. |
| up to 6 months |
| 24035300 | Background | Sun J, Teng J, Yang H, Li Z, Zhang J, Zhao H, Garfield DH, Han B. Endobronchial ultrasound-guided transbronchial needle aspiration in diagnosing intrathoracic tuberculosis. Ann Thorac Surg. 2013 Dec;96(6):2021-7. doi: 10.1016/j.athoracsur.2013.07.005. Epub 2013 Sep 12. |
| 25497069 | Background | Sun J, Yang H, Teng J, Zhang J, Zhao H, Garfield DH, Han B. Determining factors in diagnosing pulmonary sarcoidosis by endobronchial ultrasound-guided transbronchial needle aspiration. Ann Thorac Surg. 2015 Feb;99(2):441-5. doi: 10.1016/j.athoracsur.2014.09.029. Epub 2014 Dec 12. |
| 27882677 | Background | Yang H, Wang S, Teng J, Han B, Sun J. Utility of endobronchial ultrasound-guided transbronchial needle aspiration in diagnosing non-specific inflammatory intrathorcacic lymphadenitis. Clin Respir J. 2018 Feb;12(2):691-698. doi: 10.1111/crj.12580. Epub 2016 Nov 23. |