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

Diagnoses Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04056273
• Other study ID #: 201904072RINC
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: April 2023

Study information

• Verified date: October 2021
• Source: National Taiwan University Hospital
• Contact: Chao-Chi Ho
• Phone: 02-23123456
• Email: ccho1203[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 586
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diagnoses Disease
• Lung Neoplasms
• Lung Tumor

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Dhooria S, Sehgal IS, Gupta N, Aggarwal AN, Behera D, Agarwal R. Role of radial endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of pulmonary nodules: Case report and literature review. Lung India. 2017 Jan-Feb;34(1):61-64 — View Citation

Eom JS, Mok JH, Kim I, Lee MK, Lee G, Park H, Lee JW, Jeong YJ, Kim WY, Jo EJ, Kim MH, Lee K, Kim KU, Park HK. Radial probe endobronchial ultrasound using a guide sheath for peripheral lung lesions in beginners. BMC Pulm Med. 2018 Aug 13;18(1):137. doi: 1 — View Citation

Hayama M, Okamoto N, Suzuki H, Tamiya M, Shiroyama T, Tanaka A, Nishida T, Nishihara T, Uehara N, Morishita N, Kawahara K, Hirashima T. Radial endobronchial ultrasound with a guide sheath for diagnosis of peripheral cavitary lung lesions: a retrospective — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic yield rate i. Brushing cytology ii. Biopsy	The diagnostic yield rate of transbronchial biopsy and brushing cytology by using guide sheath	2 years
Secondary	Procedure duration	The procedure time of using a guide sheath	1 year
Secondary	Complication rate (pneumothorax, hemoptysis)	The complication rate of using a guide sheath	1 year