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Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection

NCT03617029 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-12-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Microcoil

Needle localization with microcoil

DRUG

Lipiodol

Needle localization with contrast injection

Sponsors & Collaborators

  • National Taiwan University Hospital Hsin-Chu Branch

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2019-10-31
Completion
2019-12-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617029 on ClinicalTrials.gov