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| Name | Class |
|---|---|
| Air Force Military Medical University, China | OTHER |
| Xiangya Hospital of Central South University | OTHER |
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The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENB-EBUS-GS group | Experimental | ENB is used in this group.EBUS and GS are inserted into bronchi in the assistance of ENB. The EBUS probe and GS are confirmed to reach the lesion by EBUS images. |
|
| EBUS-GS group | Active Comparator | ENB isn't used in this group.EBUS and GS are inserted into bronchi according to the chest CT that judged by the doctor. The EBUS probe and GS are confirmed to reach the lesion by EBUS images. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENB | Device | ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules. |
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| Measure | Description | Time Frame |
|---|---|---|
| The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group | Diagnostic yield is defined as proportion of true positive and true negative. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| The difference of operation time between ENB-EBUS-GS group and EBUS-GS group | The operation time includes total operation time,total GS time and total EBUS time | one week |
| The difference of complications between ENB-EBUS-GS group and EBUS-GS group |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, MD,PhD | Contact | 86-21-22200000 | 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 | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24401166 | Background | Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM. Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration. 2014;87(2):165-76. doi: 10.1159/000355710. Epub 2014 Jan 3. | |
| 23649436 | Background | Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e142S-e165S. doi: 10.1378/chest.12-2353. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 22, 2022 | |
| Reset | Mar 31, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 22, 2022 | Mar 31, 2023 |
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| EBUS-GS | Device | EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus). |
|
Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation
| three months |
| 20435658 | Background | Seijo LM, de Torres JP, Lozano MD, Bastarrika G, Alcaide AB, Lacunza MM, Zulueta JJ. Diagnostic yield of electromagnetic navigation bronchoscopy is highly dependent on the presence of a Bronchus sign on CT imaging: results from a prospective study. Chest. 2010 Dec;138(6):1316-21. doi: 10.1378/chest.09-2708. Epub 2010 Apr 30. |
| 22391437 | Background | Lamprecht B, Porsch P, Wegleitner B, Strasser G, Kaiser B, Studnicka M. Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield. Respir Med. 2012 May;106(5):710-5. doi: 10.1016/j.rmed.2012.02.002. Epub 2012 Mar 3. |
| 21980059 | Background | 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. |
| 35679184 | Derived | Zheng X, Cao L, Zhang Y, Xie F, Yang H, Liu J, Qu S, Zhang J, Sun J. A Novel Electromagnetic Navigation Bronchoscopy System for the Diagnosis of Peripheral Pulmonary Nodules: A Randomized Clinical Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1730-1739. doi: 10.1513/AnnalsATS.202109-1071OC. |