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

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ClinicalTrials.gov Identifier: NCT01895166
Recruitment Status : Unknown
Verified July 2013 by Jiayuan Sun, Shanghai Chest Hospital.
Recruitment status was:  Recruiting
First Posted : July 10, 2013
Last Update Posted : July 31, 2013
Sponsor:
Collaborator:
Fukushima Medical University
Information provided by (Responsible Party):
Jiayuan Sun, Shanghai Chest Hospital

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of endobronchial ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

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

Detailed Description:
The investigators evaluated the efficacy and safety of transbronchial biopsy (TBB) and bronchial brushing by endobronchial ultrasonography (EBUS) with a guide sheath (GS) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope center, Shanghai chest Hospital affiliated to Shanghai JiaoTong University School, China. Department of pulmonary medicine, Fukushima Medical University, Japan.Patients are divided into two groups, EBUS-GS-X-ray group and EBUS-GS group.Each subject will be randomized to each group.The study is expected to enroll 100 patients at 2 centers (China:75, Fukushima:25).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Value of Endobronchial Ultrasound(EBUS) With a Guide Sheath(GS) for Peripheral Pulmonary Lesions(PPLs) Without Fluoroscopy: a Randomized Controlled Trial
Study Start Date : July 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays

Arm Intervention/treatment
Experimental: EBUS-GS group
The EBUS probe and GS are confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance.
Procedure: 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: EBUS-GS-X-ray group
The EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained under fluoroscopic guidance.
Procedure: 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).

Procedure: 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 EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone [ Time Frame: Up to half year ]
    The diagnostic value mean sensitivity and specificity in two groups


Secondary Outcome Measures :
  1. The difference of complications of EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone [ Time Frame: Up to half year ]
    Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation in two groups



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Individuals eligible for inclusion are patients that the CT scan appearance of the PPLs showed the longest diameter was more than 2 cm and solid lesions.

Exclusion Criteria:

  1. The lesion is close to the pleural membrane
  2. Refusal of participation
  3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy

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): NCT01895166


Contacts
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Contact: Jiayuan Sun, MD 86-21-22200000-1421 jysun1976@163.com

Locations
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China
Shanghai Chest Hospital Recruiting
Shanghai, China, 200030
Contact: Jiayuan Sun       jysun1976@163.com   
Principal Investigator: Jiayuan Sun, MD         
Sponsors and Collaborators
Shanghai Chest Hospital
Fukushima Medical University
Investigators
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Principal Investigator: Jiayuan Sun, MD Shanghai Chest Hospital

Publications:
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Responsible Party: Jiayuan Sun, Director, Endoscope Center, Shanghai Chest Hospital, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT01895166     History of Changes
Other Study ID Numbers: SHCHE201301
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Jiayuan Sun, Shanghai Chest Hospital:
Endobronchial ultrasonography with a guide sheath
Peripheral pulmonary lesions
Transbronchial biopsy