Assess the Use of rEBUS With a Guide Sheath to Increase Transbronchial Lung Biopsy Yield Rate

National Taiwan University

Status: Unknown

Conditions: Lung Tumor; Diagnoses Disease

Treatments: Other: Guide sheath group; Other: Conventional group

Study type: Interventional

Funder types: Other

Identifiers

NCT04056273

201904072RINC

Details and patient eligibility

About

Whether using a guide sheath can increase the diagnostic yield rate after the lesion is located by radial endobronchial ultrasound

Full description

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.

Enrollment: 586 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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586 participants in 2 patient groups

Guide sheath group

Experimental group

Description:

Transbronchial biopsy with a guide sheath

Treatment:

Other: Guide sheath group

Conventional group

Active Comparator group

Description:

Transbronchial biopsy without a guide sheath

Treatment:

Other: Conventional group