Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection
Preoperative Localization With Microcoil Placement or Contrast Injection for Deep-seated Pulmonary Nodule : A Prospective Randomized Trial
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hsin-Chu County
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Taipei, Hsin-Chu County, Taiwan, 30059
- Recruiting
- National Taiwan University Hospital, Hsin-Chu Branch
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Contact:
- Chiu-kuei Nien
- Phone Number: 886-3-5326151
- Email: hch01215@hch.gov.tw
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Deep lung lesions
Exclusion Criteria:
Emphysema COPD Previous ilpislateral surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Microcoil
Needle localization for deep-seated lung nodules with microcoil placement
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Needle localization with microcoil
|
|
Active Comparator: Contrast
Needle localization for deep-seated lung nodules with contrast injection
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Needle localization with contrast injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedure success rate
Time Frame: 1 day
|
Procedure success is defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire.
The procedure success rate is calculated as follows: procedure success rate (%) = (number of procedure success / number of total procedure) × 100.
|
1 day
|
|
Successful localization for surgery
Time Frame: 1 day
|
Localization contribute to surgery
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedure-related complication rate
Time Frame: 1 day
|
Incidence of complications during needle procedure, The procedure-related complication rate is calculated as follows: procedure-related complication rate (%) = (number of procedure-related complication / number of total procedure) × 100.
|
1 day
|
|
Duration of the localization procedure
Time Frame: 1 day
|
From start of needle procedure to withdraw of the needle (minutes)
|
1 day
|
|
Duration of wedge resection
Time Frame: 1 day
|
From start of surgery to completion of pulmonary wedge resection (minutes)
|
1 day
|
|
Surgical margin of wedge resection
Time Frame: 1 day
|
Distance from pulmonary lesion to resection margin of the specimen
|
1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 107-032-F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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