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

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

Study Overview

• Status: Recruiting
• Conditions: Diagnoses Disease; Lung Tumor
• Intervention / Treatment: Other: Guide sheath group; Other: Conventional group

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 Type: Interventional
• Enrollment (Anticipated): 586
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chao-Chi Ho; Phone Number: 62905 02-23123456; Email: ccho1203@ntu.edu.tw
• Study Contact Backup: Name: Hao-Chun Chang; Phone Number: +886-972655250; Email: jasonchang104@gmail.com

Study Locations

• Taiwan
  • Taipei City, Taiwan, 10002
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chao-Chi Ho; Phone Number: 67485 02-23123456; Email: ccho1203@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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. doi: 10.4103/0970-2113.197094.
• 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: 10.1186/s12890-018-0704-7.
• 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 study. BMC Pulm Med. 2016 May 11;16(1):76. doi: 10.1186/s12890-016-0244-y.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: August 11, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: guide sheath, bronchoscopic biopsy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 201904072RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No