Electromagnetic Navigation Versus CT Guided TTNA in the Diagnosis of Early Peripheral Lung Cancer

NCT ID: NCT03802266

Last Updated: 2019-01-14

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

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-30

Brief Summary

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The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule.

Primary endpoints:Diagnostic rate Secondary endpoints:operating time、adverse events Study design: Multicenter、randomized、open lebel

Detailed Description

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Conditions

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Lung Cancer

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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Electromagnetic Navigation group

Electromagnetic Navigation Guided Transthoracic Needle Aspiration

Group Type EXPERIMENTAL

Electromagnetic Navigation guided transthoracic needle aspiration

Intervention Type DEVICE

Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule

CT group

CT-guided Transthoracic Needle Aspiration

Group Type ACTIVE_COMPARATOR

CT-guided Transthoracic Needle Aspiration

Intervention Type DEVICE

Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule

Interventions

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Electromagnetic Navigation guided transthoracic needle aspiration

Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule

Intervention Type DEVICE

CT-guided Transthoracic Needle Aspiration

Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis;
2. Patients who are older than 18 year-old;
3. Patients voluntarily join the study and give written informed consent for the study.

Exclusion Criteria

1. Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
2. Large blood vessels or important structures on the puncture path of peripheral lung tumors;
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Third Military Medical University

OTHER

Sponsor Role collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hua Zhong

Professor Hua Zhong

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hua Zhong, Phd,MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

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Shanghai Chest hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Zhong, Phd,MD

Role: CONTACT

13818200560

Facility Contacts

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Hua Zhong, MD,PhD

Role: primary

86-21-22200000 ext. 3902

Shuhui Cao, MD

Role: backup

86-21-22200000 ext. 3909

Other Identifiers

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Chest 010

Identifier Type: -

Identifier Source: org_study_id

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