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

NCT ID: NCT01895166

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Lung Cancer

Keywords

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Endobronchial ultrasonography with a guide sheath Peripheral pulmonary lesions Transbronchial biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

EBUS-GS

Intervention Type PROCEDURE

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-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.

Group Type ACTIVE_COMPARATOR

EBUS-GS

Intervention Type PROCEDURE

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).

X-ray

Intervention Type PROCEDURE

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.

Interventions

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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).

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fukushima Medical University

OTHER

Sponsor Role collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiayuan Sun

Director, Endoscope Center, Shanghai Chest Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiayuan Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

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Shanghai Chest Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiayuan Sun, MD

Role: CONTACT

Phone: 86-21-22200000-1421

Email: [email protected]

Facility Contacts

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Jiayuan Sun

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 15364779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17565021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17573504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20693253 (View on PubMed)

Other Identifiers

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SHCHE201301

Identifier Type: -

Identifier Source: org_study_id