VBN-EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs

NCT02484066 | Completed DMC

• 1 other identifier: SHCHE201503
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the feasibility, efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing by using virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) and a Guide Sheath (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

Conditions

Lung Cancer

Keywords

Virtual bronchoscopic navigation; Endobronchial ultrasound; Guide Sheath; Transbronchial biopsy; Peripheral pulmonary lesions

Outcome Measures

Primary Outcomes (1)

• The difference of diagnostic value of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB

  The diagnostic value means sensitivity and specificity in two groups

  one year

Secondary Outcomes (2)

• The difference of operation time of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB

  one year

• The difference of complications of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB

  one year

Study Arms (2)

VBN-EBUS-GS group

EXPERIMENTAL

Fluoroscopy are not used in this group. EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance.

Device: VBN; Device: EBUS-GS

VBN-EBUS-GS-X-ray group

ACTIVE COMPARATOR

EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained with fluoroscopic guidance.

Device: VBN; Device: EBUS-GS; Device: X-ray

Interventions

VBN DEVICE

VBN is carried out by a VBN software（DirectPath; Olympus, Japan) which can automatically create virtual bronchoscopic images.

VBN-EBUS-GS group; VBN-EBUS-GS-X-ray group

EBUS-GS DEVICE

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).

VBN-EBUS-GS group; VBN-EBUS-GS-X-ray group

X-ray DEVICE

The radiograph fluoroscopy are performed when the probe and GS are confirmed to reach the lesion by EBUS images ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.

VBN-EBUS-GS-X-ray group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 brochoscopy procerdure

Sponsors & Collaborators

• Jiayuan Sun: lead
• Chinese Academy of Medical Sciences: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, 200030, China

Location

Related Publications (5)

• Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65. doi: 10.1378/chest.126.3.959.

  PMID: 15364779 BACKGROUND

• Yoshikawa M, Sukoh N, Yamazaki K, Kanazawa K, Fukumoto S, Harada M, Kikuchi E, Munakata M, Nishimura M, Isobe H. Diagnostic value of endobronchial ultrasonography with a guide sheath for peripheral pulmonary lesions without X-ray fluoroscopy. Chest. 2007 Jun;131(6):1788-93. doi: 10.1378/chest.06-2506.

  PMID: 17565021 BACKGROUND

• Yamada N, Yamazaki K, Kurimoto N, Asahina H, Kikuchi E, Shinagawa N, Oizumi S, Nishimura M. Factors related to diagnostic yield of transbronchial biopsy using endobronchial ultrasonography with a guide sheath in small peripheral pulmonary lesions. Chest. 2007 Aug;132(2):603-8. doi: 10.1378/chest.07-0637. Epub 2007 Jun 15.

  PMID: 17573504 BACKGROUND

• Steinfort DP, Khor YH, Manser RL, Irving LB. Radial probe endobronchial ultrasound for the diagnosis of peripheral lung cancer: systematic review and meta-analysis. Eur Respir J. 2011 Apr;37(4):902-10. doi: 10.1183/09031936.00075310. Epub 2010 Aug 6.

  PMID: 20693253 BACKGROUND

• Ishida T, Asano F, Yamazaki K, Shinagawa N, Oizumi S, Moriya H, Munakata M, Nishimura M; Virtual Navigation in Japan Trial Group. Virtual bronchoscopic navigation combined with endobronchial ultrasound to diagnose small peripheral pulmonary lesions: a randomised trial. Thorax. 2011 Dec;66(12):1072-7. doi: 10.1136/thx.2010.145490. Epub 2011 Jul 11.

  PMID: 21749984 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sun Jiayuan, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Endoscopy, Shanghai Chest Hospital

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 29, 2015
• Study Start: September 1, 2018
• Primary Completion: July 30, 2019
• Study Completion: December 1, 2020
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

CN (1)