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

Assessment of the Use of Radial Endobronchial Ultrasonography With a Guide Sheath in Increasing the Yield Rate of Transbronchial Lung Biopsy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04056273

Enrollment

586

Registered

2019-08-14

Start date

2019-09-01

Completion date

2023-04-30

Last updated

2021-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnoses Disease, Lung Tumor

Keywords

guide sheath, bronchoscopic biopsy

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.

Interventions

OTHERGuide sheath group

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.

OTHERConventional group

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Taiwan

Contacts

Primary ContactChao-Chi Ho

ccho1203@ntu.edu.tw02-23123456

Backup ContactHao-Chun Chang

jasonchang104@gmail.com+886-972655250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026