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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04056273

Collaborator

(none)

586

Enrollment

Location

Arms

Anticipated Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diagnoses Disease Lung Tumor	Other: Guide sheath group Other: Conventional group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

586 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guide sheath group Transbronchial biopsy with a guide sheath	Other: Guide 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.
Active Comparator: Conventional group Transbronchial biopsy without a guide sheath	Other: Conventional 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.

Arm

Intervention/Treatment

Experimental: Guide sheath group

Transbronchial biopsy with a guide sheath

Other: Guide 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.

Active Comparator: Conventional group

Transbronchial biopsy without a guide sheath

Other: Conventional 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei City		Taiwan	10002

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator: Chao-Chi Ho, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT04056273

Other Study ID Numbers:

201904072RINC

First Posted:

Aug 14, 2019

Last Update Posted:

Oct 20, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

guide sheath, bronchoscopic biopsy

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Oct 20, 2021