NCT03575715

Brief Summary

The study is aimed to evaluate the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of endobronchial ultrasound (EBUS) image features in diagnosing peripheral pulmonary lesions (PPLs).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

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

June 21, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

June 21, 2018

Last Update Submit

June 29, 2018

Conditions

Endobronchial Ultrasound

Keywords

endobronchial ultrasoundperipheral pulmonary lesionsimage features

Outcome Measures

Primary Outcomes (1)

  • The diagnostic value of EBUS image features

    The diagnostic value includes sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate.

    one year

Secondary Outcomes (1)

  • EBUS image features of adenocarcinoma

    one year

Study Arms (1)

EBUS group

EXPERIMENTAL

EBUS and guide sheath (GS) are inserted into bronchi in the assistance of navigation bronchoscopy. The EBUS probe and GS are confirmed to reach the lesion by EBUS images, cytologic and pathologic specimens are obtained with or without fluoroscopic guidance.

Device: EBUS

Interventions

EBUSDEVICE

EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).

EBUS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are older than 18 year-old.
  • Chest CT shows PPLs suspected to be malignant that need to be confirmed by pathology. The lesion is surrounded by lung parenchyma and invisible in standard bronchoscopy.
  • Patients who agree to undergo bronchoscopy without any contraindications.
  • Patients who have good compliance and sign informed consent.

You may not qualify if:

  • Absence of bronchus leading to or adjacent to the lesion from CT scan.
  • Refusal of participation.
  • Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
  • Presence of concomitant endobronchial lesion during the bronchoscopy procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Chao TY, Lie CH, Chung YH, Wang JL, Wang YH, Lin MC. Differentiating peripheral pulmonary lesions based on images of endobronchial ultrasonography. Chest. 2006 Oct;130(4):1191-7. doi: 10.1378/chest.130.4.1191.

    PMID: 17035455BACKGROUND

  • Izumo T, Sasada S, Chavez C, Matsumoto Y, Tsuchida T. Radial endobronchial ultrasound images for ground-glass opacity pulmonary lesions. Eur Respir J. 2015 Jun;45(6):1661-8. doi: 10.1183/09031936.00167914. Epub 2015 Jan 8.

    PMID: 25573408BACKGROUND

  • Kurimoto N, Murayama M, Yoshioka S, Nishisaka T. Analysis of the internal structure of peripheral pulmonary lesions using endobronchial ultrasonography. Chest. 2002 Dec;122(6):1887-94. doi: 10.1378/chest.122.6.1887.

    PMID: 12475821BACKGROUND

  • Yasufuku K. Current clinical applications of endobronchial ultrasound. Expert Rev Respir Med. 2010 Aug;4(4):491-8. doi: 10.1586/ers.10.39.

    PMID: 20658910BACKGROUND

  • Travis WD, Rekhtman N, Riley GJ, Geisinger KR, Asamura H, Brambilla E, Garg K, Hirsch FR, Noguchi M, Powell CA, Rusch VW, Scagliotti G, Yatabe Y. Pathologic diagnosis of advanced lung cancer based on small biopsies and cytology: a paradigm shift. J Thorac Oncol. 2010 Apr;5(4):411-4. doi: 10.1097/JTO.0b013e3181d57f6e. No abstract available.

    PMID: 20357614BACKGROUND

Study Officials

  • Lei Wang, MD

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Wang, MD

CONTACT

86-021-2220000013917985547@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 2, 2018

Study Start

July 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 2, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share