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Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection

N

National Taiwan University Hospital Hsin-Chu Branch

Status

Unknown

Conditions

Lung Cancer

Treatments

Device: Microcoil
Drug: Lipiodol

Study type

Interventional

Funder types

Other

Identifiers

NCT03617029
107-032-F

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Deep lung lesions

Exclusion criteria

Emphysema COPD Previous ilpislateral surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Microcoil
Experimental group
Description:
Needle localization for deep-seated lung nodules with microcoil placement
Treatment:
Device: Microcoil
Contrast
Active Comparator group
Description:
Needle localization for deep-seated lung nodules with contrast injection
Treatment:
Drug: Lipiodol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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