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

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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

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

Trial contacts and locations

1

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Central trial contact

Hao-Chun Chang; Chao-Chi Ho

Data sourced from clinicaltrials.gov

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