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

Primary Purpose

Diagnoses Disease, Lung Tumor

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Guide sheath group
Conventional group
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnoses Disease focused on measuring guide sheath, bronchoscopic biopsy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guide sheath group

Conventional group

Arm Description

Transbronchial biopsy with a guide sheath

Transbronchial biopsy without a guide sheath

Outcomes

Primary Outcome Measures

The diagnostic yield rate i. Brushing cytology ii. Biopsy
The diagnostic yield rate of transbronchial biopsy and brushing cytology by using guide sheath

Secondary Outcome Measures

Procedure duration
The procedure time of using a guide sheath
Complication rate (pneumothorax, hemoptysis)
The complication rate of using a guide sheath

Full Information

First Posted
August 11, 2019
Last Updated
October 19, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04056273
Brief Title
Assess the Use of rEBUS With a Guide Sheath to Increase Transbronchial Lung Biopsy Yield Rate
Official Title
Assessment of the Use of Radial Endobronchial Ultrasonography With a Guide Sheath in Increasing the Yield Rate of Transbronchial Lung Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnoses Disease, Lung Tumor
Keywords
guide sheath, bronchoscopic biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
586 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guide sheath group
Arm Type
Experimental
Arm Description
Transbronchial biopsy with a guide sheath
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
Transbronchial biopsy without a guide sheath
Intervention Type
Other
Intervention Name(s)
Guide sheath group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The diagnostic yield rate i. Brushing cytology ii. Biopsy
Description
The diagnostic yield rate of transbronchial biopsy and brushing cytology by using guide sheath
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Procedure duration
Description
The procedure time of using a guide sheath
Time Frame
1 year
Title
Complication rate (pneumothorax, hemoptysis)
Description
The complication rate of using a guide sheath
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chao-Chi Ho
Phone
02-23123456
Ext
62905
Email
ccho1203@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hao-Chun Chang
Phone
+886-972655250
Email
jasonchang104@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao-Chi Ho
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao-Chi Ho
Phone
02-23123456
Ext
67485
Email
ccho1203@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28144062
Citation
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.
Results Reference
result
PubMed Identifier
30103727
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: 10.1186/s12890-018-0704-7.
Results Reference
result
PubMed Identifier
27170169
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 study. BMC Pulm Med. 2016 May 11;16(1):76. doi: 10.1186/s12890-016-0244-y.
Results Reference
result

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

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