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

Not Applicable

• Conditions: Diagnoses Disease; Lung Tumor
• Interventions: Other: Guide sheath group; Other: Conventional group

• Registration Number: NCT04056273
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-08-11
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-14
• Study Start: 2019-09-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-20
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 586

Inclusion Criteria

Age ≥ 20 years old. Radiographic evidence of peripheral pulmonary lesions. The lesion can be located by radial probe EBUS.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guide sheath group	Guide sheath group	Transbronchial biopsy with a guide sheath
Conventional group	Conventional group	Transbronchial biopsy without a guide sheath

Primary Outcome Measures

Name	Time	Method
The diagnostic yield rate i. Brushing cytology ii. Biopsy	2 years	The diagnostic yield rate of transbronchial biopsy and brushing cytology by using guide sheath

Secondary Outcome Measures

Name	Time	Method
Complication rate (pneumothorax, hemoptysis)	1 year	The complication rate of using a guide sheath
Procedure duration	1 year	The procedure time of using a guide sheath

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan