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Trial record 2 of 2 for:    17573504 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02484066
Recruitment Status : Recruiting
First Posted : June 29, 2015
Last Update Posted : October 2, 2018
Sponsor:
Collaborators:
Chinese Academy of Medical Sciences
The First Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Jiayuan Sun, Shanghai Chest Hospital

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: VBN Device: EBUS-GS Device: X-ray Not Applicable

Detailed Description:
The investigators 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) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a three centers prospective randomized controlled trial.The participating centers are Department of endoscopy , Shanghai chest Hospital, Shanghai JiaoTong University, China. Department of endoscopy, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, China. Department of Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical University, China. Patients are divided into two groups, VBN-EBUS-GS-X-ray group and VBN-EBUS-GS group. Each subject will be randomized to each group. The study is expected to enroll 436 patients at 3 centers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Value of Virtual Bronchoscopic Navigation (VBN) Combined With Endobronchial Ultrasound (EBUS) With a Guide Sheath (GS) for Peripheral Pulmonary Lesions (PPLs) Without Fluoroscopy: a Randomized Controlled Trial
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
Experimental: VBN-EBUS-GS group
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
VBN is carried out by a VBN software(DirectPath; Olympus, Japan) which can automatically create virtual bronchoscopic images.

Device: EBUS-GS
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).

Active Comparator: VBN-EBUS-GS-X-ray 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 and radiograph fluoroscopy, cytologic and pathologic specimens are obtained with fluoroscopic guidance.
Device: VBN
VBN is carried out by a VBN software(DirectPath; Olympus, Japan) which can automatically create virtual bronchoscopic images.

Device: EBUS-GS
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).

Device: X-ray
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.




Primary Outcome Measures :
  1. The difference of diagnostic value of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB [ Time Frame: one year ]
    The diagnostic value means sensitivity and specificity in two groups


Secondary Outcome Measures :
  1. The difference of operation time of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB [ Time Frame: one year ]
    The operation time includes total operation time,total GS time and total EBUS time

  2. The difference of complications of VBN-EBUS-GS-TBLB with fluoroscopy as compared to VBN-EBUS-GS-TBLB [ Time Frame: one year ]
    Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals eligible for inclusion are patients that the CT scan appearance of the PPLs showed the longest diameter was more than 8mm and non GGO lesions.

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 brochoscopy procerdure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484066


Contacts
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Contact: Sun Jiayuan, MD 86-21-22200000-1511 jysun1976@163.com

Locations
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China
Shanghai Chest Hospital Recruiting
Shanghai, China, 200030
Contact: Jiayuan Sun, MD       jysun1976@163.com   
Principal Investigator: Jiayuan Sun, MD         
Sponsors and Collaborators
Jiayuan Sun
Chinese Academy of Medical Sciences
The First Affiliated Hospital of Guangzhou Medical University
Investigators
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Principal Investigator: Sun Jiayuan, MD Shanghai Chest Hospital

Publications:
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Responsible Party: Jiayuan Sun, Director, Department of Endoscopy, Shanghai Chest Hospital, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT02484066     History of Changes
Other Study ID Numbers: SHCHE201503
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiayuan Sun, Shanghai Chest Hospital:
Virtual bronchoscopic navigation
Endobronchial ultrasound
Guide Sheath
Transbronchial biopsy
Peripheral pulmonary lesions