NCT04056273

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
586

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

3.6 years

First QC Date

August 11, 2019

Last Update Submit

October 19, 2021

Conditions

Diagnoses DiseaseLung Tumor

Keywords

guide sheath, bronchoscopic biopsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Procedure duration

    1 year

  • Complication rate (pneumothorax, hemoptysis)

    1 year

Study Arms (2)

Guide sheath group

EXPERIMENTAL

Transbronchial biopsy with a guide sheath

Other: Guide sheath group

Conventional group

ACTIVE COMPARATOR

Transbronchial biopsy without a guide sheath

Other: Conventional group

Interventions

Guide sheath groupOTHER

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.

Guide sheath group
Conventional groupOTHER

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.

Conventional group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 20 years old. Radiographic evidence of peripheral pulmonary lesions. The lesion can be located by radial probe EBUS.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Related 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. doi: 10.4103/0970-2113.197094.

    PMID: 28144062RESULT

  • 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.

    PMID: 30103727RESULT

  • 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.

    PMID: 27170169RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chao-Chi Ho

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Chi Ho

CONTACT

02-23123456ccho1203@ntu.edu.tw

Hao-Chun Chang

CONTACT

+886-972655250jasonchang104@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2019

First Posted

August 14, 2019

Study Start

September 1, 2019

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

October 20, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)