Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection

NCT ID: NCT03617029

Last Updated: 2018-12-04

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2019-12-31

Brief Summary

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In recent years, the development of low-dose pulmonary computed tomography screening has led to the discovery of many small pulmonary nodules in the early stages.

Surgical resection is still the main treatment for those suspected malignant lesions. In the face of such small pulmonary nodules, accurate preoperative localization has become the key to successful resection, and the deep-seated nodules are the most challenging parts. Because the deep-seated nodules cannot be localized by surface dye injection, however, it is necessary to place a fiducial marker (such as a microcoil) or contrast medium injection in combination with intraoperative fluoroscopy to ensure adequate resection of the deep-seated nodules. . This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 60 patients with pulmonary nodules with a depth larger than 2 cm will be randomly assigned into two groups. One group will receive microcoil placement, and the other group will receive contrast medium injection. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.

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

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Microcoil

Needle localization for deep-seated lung nodules with microcoil placement

Group Type EXPERIMENTAL

Microcoil

Intervention Type DEVICE

Needle localization with microcoil

Contrast

Needle localization for deep-seated lung nodules with contrast injection

Group Type ACTIVE_COMPARATOR

Lipiodol

Intervention Type DRUG

Needle localization with contrast injection

Interventions

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Microcoil

Needle localization with microcoil

Intervention Type DEVICE

Lipiodol

Needle localization with contrast injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Deep lung lesions

Exclusion Criteria

Emphysema COPD Previous ilpislateral surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital, Hsin-Chu Branch

Taipei, Hsin-Chu County, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Chiu-kuei Nien

Role: primary

886-3-5326151

Other Identifiers

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107-032-F

Identifier Type: -

Identifier Source: org_study_id

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