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Whether using a guide sheath can increase the diagnostic yield rate after the lesion is located by radial endobronchial ultrasound
For lung nodules, there are several ways to acquire tissue for pathology study, including computed tomography (CT)-guided core needle biopsy, radial probe endobronchial ultrasound (rEBUS)-guided transbronchial lung biopsy (TBLB), convex probe EBUS transbronchial needle aspiration (TBNA), and echo-guided core needle biopsy. rEBUS-guided TBLB has relatively low limitation of lesion position, comparing to echo-guided core needle biopsy and EBUS-TBNA, and doesn't need to deal with the risk of radiation exposure.1 For peripheral pulmonary lesions (PPL), it has good yield rate and the operation is easy.2 However, when bleeding occurs, the procedure time is prolonged for hemostasis. Nonetheless, using a guide sheath can help with the problem. According to the literatures, biopsy yield rates vary but on average it is higher with a guide sheath (62~90% vs. 41~73%), while the complication rates are about the same (1.3~4.4% 1.5~5.0%). The investigators would like to know whether the diagnostic rate is higher with a guide sheath and so do the procedure time and the complication rate. Whether the lesion character affect the yield rate will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guide sheath group | Experimental | Transbronchial biopsy with a guide sheath |
|
| Conventional group | Active Comparator | Transbronchial biopsy without a guide sheath |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guide sheath group | Other | After the lesion was found by rEBUS, insert the rEBUS into a guide sheath and re-locate the lesion. Fix the guide sheath at that position and perform transbronchial biopsy and brushing through the guide sheath. |
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic yield rate i. Brushing cytology ii. Biopsy | The diagnostic yield rate of transbronchial biopsy and brushing cytology by using guide sheath | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure duration | The procedure time of using a guide sheath | 1 year |
| Complication rate (pneumothorax, hemoptysis) | The complication rate of using a guide sheath |
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Inclusion Criteria:
Age ≥ 20 years old. Radiographic evidence of peripheral pulmonary lesions. The lesion can be located by radial probe EBUS.
Exclusion Criteria:
B1 bronchus. Thrombocytopenia with platelet count < 100K. Coagulopathy with INR > 1.3. High oxygen demand (O2 mask > 28%, 5L). Currently using anti-platelet drug or anti-coagulant.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao-Chi Ho | Contact | 02-23123456 | 62905 | ccho1203@ntu.edu.tw |
| Hao-Chun Chang | Contact | +886-972655250 | jasonchang104@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chao-Chi Ho | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28144062 | Result | Dhooria S, Sehgal IS, Gupta N, Aggarwal AN, Behera D, Agarwal R. Role of radial endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of pulmonary nodules: Case report and literature review. Lung India. 2017 Jan-Feb;34(1):61-64. doi: 10.4103/0970-2113.197094. | |
| 30103727 | Result | Eom JS, Mok JH, Kim I, Lee MK, Lee G, Park H, Lee JW, Jeong YJ, Kim WY, Jo EJ, Kim MH, Lee K, Kim KU, Park HK. Radial probe endobronchial ultrasound using a guide sheath for peripheral lung lesions in beginners. BMC Pulm Med. 2018 Aug 13;18(1):137. doi: 10.1186/s12890-018-0704-7. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Conventional group | Other | After the lesion was found by rEBUS, mark the location and depth. Insert the biopsy forceps and cytology brush to the marked depth of that bronchiole to perform biopsy and brushing. |
|
| 1 year |
| 27170169 | Result | Hayama M, Okamoto N, Suzuki H, Tamiya M, Shiroyama T, Tanaka A, Nishida T, Nishihara T, Uehara N, Morishita N, Kawahara K, Hirashima T. Radial endobronchial ultrasound with a guide sheath for diagnosis of peripheral cavitary lung lesions: a retrospective study. BMC Pulm Med. 2016 May 11;16(1):76. doi: 10.1186/s12890-016-0244-y. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |