Lipiodol Localization for Ground-glass-opacity Minimal Surgery

Study Overview
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Brief Summary
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The study object is to demonstrate the usefulness and safety of lipiodol localization technique for individuals undergoing ground-glass opacity (GGO) Video-assisted thoracic surgery (VATS) resection compared to hook wire localization technique. A total of 250 participants will be enrolled in a 1:1 fashion to Lipiodol or Hook-wire groups. If the aims of this study are achieved, the use of lipiodol localization technique will be widespread their application for localization of non-palpable pulmonary lesions that are indicated for VATS resection.

Official Title
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Validation Study to Evaluate the Safety and Efficacy of Preoperative Computed Tomography-guided Localization Technique Using Lipiodol for Patients With Ground Glass Opacity Pulmonary Lesions: A Prospective Multicenter Study

Conditions
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Pulmonary Lesion With Ground-glass-opacity

Intervention / Treatment
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* Procedure: Lipiodol
* Procedure: Hookwire
* Drug: Lipiodol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting adult patients ≥ 20 years of age Pulmonary lesion with a ground glass opacity(GGO)component of more than 50% Patient with lesion size less than 3cm Persistence or growth of the established lesion within a three month period Patient who are not contraindicated to surgery Patients who are willing to sign the informed consent form Exclusion Criteria: Patients with solid pulmonary lesion Patients with multiple GGOs need multiple localization Patients who are contraindicated to surgery Patients who behave in an uncooperative manner Unwilling or unable to give informed consent Pregnant women

Ages Eligible for Study
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Minimum Age: 20 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipiodol<br>Lipiodol-guided lung localization technique | Procedure: Lipiodol<br>* Lipiodol-guided lung localization technique<br>Drug: Lipiodol<br> <br> |
| Active Comparator: Hookwire<br>Hookwire-guided lung localization technique | Procedure: Hookwire<br>* Hookwire-guided lung localization technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure success rate | Procedure success was defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire. | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Procedure-related complications such as pneumothorax, lung hemorrhage, hemoptysis, air-embolism and death | one day | 
| Procedure time | Total procedure time for lung localization | 1 hour | 
| Surgery time | Surgery time for obtaining wedge resection specimen | 12 hours | 
| Safety resection margin | The safety specimen resection margin was categorized either as positive (grossly positive (R2), microscopically positive if tumor was at the inked surface (R1)), or negative (microscopically negative if there was no tumor at the inked surface (R0)) | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ground-glass-opacity (GGO), Lung localization, Lipiodol, Hook wire, Video assisted thoracic surgery (VATS)