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Status unknownNCT03575715Updated Jul 2, 2018

EBUS Image Features in the Diagnosis of PPLs

An interventional study of EBUS in Endobronchial Ultrasound, sponsored by Shanghai Chest Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-02.

Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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).

Read the detailed description

The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The investigator evaluates the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of EBUS image features in diagnosing PPLs. 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.

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Conditions studied

  • Endobronchial Ultrasound

Keywords

  • endobronchial ultrasound
  • peripheral pulmonary lesions
  • image features
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In context

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients who are older than 18 year-old.
  2. 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.
  3. Patients who agree to undergo bronchoscopy without any contraindications.
  4. Patients who have good compliance and sign informed consent.

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    EBUS group

    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

  • DeviceEBUS

    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).

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What researchers measure

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.

    Time frame: one year

Secondary outcomes

  1. EBUS image features of adenocarcinoma

    Making invasive EBUS image features of adenocarcinoma and non-invasive adenocarcinoma

    Time frame: one year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 17035455 ↗
  • 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. PubMed 25573408 ↗
  • 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. PubMed 12475821 ↗
  • Yasufuku K. Current clinical applications of endobronchial ultrasound. Expert Rev Respir Med. 2010 Aug;4(4):491-8. doi: 10.1586/ers.10.39. PubMed 20658910 ↗
  • 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. PubMed 20357614 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03575715
Lead sponsor
Shanghai Chest Hospital
Responsible party
Xu Lei (Chief Physician, Shanghai Chest Hospital) — Principal investigator
First posted
Jul 2, 2018
Start date
Jul 2018 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Jul 2, 2018

Study contacts

Lei Wang, MD
Contact
13917985547@163.com
86-021-22200000 ext. 1416
Lei Wang, MD
principal investigator · Shanghai Chest Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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