Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection

Study Overview
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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.

Official Title
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Preoperative Localization With Microcoil Placement or Contrast Injection for Deep-seated Pulmonary Nodule : A Prospective Randomized Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Microcoil
* Drug: Lipiodol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Deep lung lesions Exclusion Criteria: Emphysema COPD Previous ilpislateral surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microcoil<br>Needle localization for deep-seated lung nodules with microcoil placement | Device: Microcoil<br>* Needle localization with microcoil<br>|
| Active Comparator: Contrast<br>Needle localization for deep-seated lung nodules with contrast injection | Drug: Lipiodol<br>* Needle localization with contrast injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure success rate | 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 | Localization contribute to surgery | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related complication rate | 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 | From start of needle procedure to withdraw of the needle (minutes) | 1 day | 
| Duration of wedge resection | From start of surgery to completion of pulmonary wedge resection (minutes) | 1 day | 
| Surgical margin of wedge resection | Distance from pulmonary lesion to resection margin of the specimen | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep-seated, Needle localization, CT-guided, Thoracoscopy, Fiducial marker