Preoperative Computed Tomography-guided Localization for Lung Nodules: Localization Needle Versus Coil

Study Overview
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Brief Summary
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Preoperative computed tomography-guided localization can improve technical success rates associated with sublobar lung nodule resection conducted via video-assisted thoracoscopic surgery. This study sought to compare the clinical efficacy of computed tomography-guided localization needle and coil insertion as approaches to preoperative lung nodule localization.

Detailed Description
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Lung nodules are frequently diagnosed and often exhibit a high potential for malignancy such that they are commonly diagnosed and treated via video-assisted thoracic surgery approaches. Preoperative computed tomography-guided localization strategies are commonly employed to improve the successful rate of video-assisted thoracic surgery-guided sublobar (wedge or segmental) resection procedures. One recent meta-analysis found coil localization to be associated with the lowest rate of complications of tested localization materials. Hook-wire has also been widely used due to its simple placement approaches. However, a number of recent reports have suggested that hook-wire insertion approaches are associated with an increased potential for frequent and potentially severe complications. The use of a novel lung nodule localization needle strategy based on the modification of this previously described hook-wire approach has recently been employed in clinical contexts. Such localization needles have the potential to incur lower rates of detachment and complications relative to the hook-wire strategy without resulting in an increase in localization difficulty. The relative clinical efficacy of localization needle-based strategies compared to that of other localization materials, however, has yet to be established in the context of lung nodule localization.

Official Title
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Preoperative Computed Tomography-guided Localization for Lung Nodules: Localization Needle Versus Coil

Conditions
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Lung; Node

Intervention / Treatment
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* Device: Localization needle
* Device: Coil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with lung nodules; Patients with an intermediate-to-high risk of malignancy as established based upon radiological and clinical findings. Exclusion Criteria: Lung nodule < 5 mm; Calcification nodules; Lung nodule which decreased in size at time of follow-up; Patients with distant metastases or other severe comorbidities.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Localization needle insertion<br>Patients undergo localization needle insertion on day 1. | Device: Localization needle<br>* A localization needle which is used for preoperative localization of lung nodules.<br>|
| Active Comparator: Coil insertion<br>Patients undergo coil insertion on day 1. | Device: Coil<br>* A coil which is used for preoperative localization of lung nodules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success of localization | Lung nodule localization is considered technically successful if the coil tail or marked line can be visible during the video-assisted thoracoscopic surgery. procedure | From the date of randomization until the date of first documented failure localization from any cause, assessed up to 7 day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung nodule, Localization, Coil, Needle