Bronchoscopic ICG Injection and Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in VATS

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of transbronchial ICG and percutaneous hook-wire assisted Video-assisted thoracoscopic sublobar resection. In the control group, CT-guided percutaneous hook-wire preoperative localization will be used for surgical resection; In the experimental group, electromagnetic navigation bronchoscopy guided transbronchial ICG injection will be performed for localization before VATS.

Detailed Description
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This is a single-center, prospective, randomized trial initiated by the investigator. Subjects with pulmonary nodules who will undergo Video-assisted thoracoscopic sublobar resection will be randomly divided into two groups. In the experimental group, before the VATS operation, transbronchial ICG injection will be guided by electromagnetic navigation bronchoscopy to locate the nodule. In the control group, the subject will undergo CT guided hook-wire placement for nodule localization before VATS. The study is expected to enroll 188 patients. Finally, the effectiveness and safety of the two methods will be compared.

Official Title
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Bronchoscopic ICG Injection vs Percutaneous Hook-wire Techniques for Preoperative Lung Nodule Localization in Video-assisted Thoracoscopic Sublobar Resection: A Prospective and Randomized Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Indocyanine green (ICG)
* Device: Electromagnetic navigation bronchoscopy
* Device: Hook wire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above 18 years old; With lung nodule diameter ≤2cm and distance from pleura ≥1cm, and VATS sublobar resection is arranged; Located difficultly by intraoperative visual inspection and palpation, a preoperative location is needed. Exclusion Criteria: Cardiopulmonary function cannot tolerate general anesthesia, or other contraindications, such as uncorrectable coagulopathy; More than one pulmonary nodule requires preoperative localization; Subject underwent thoracic surgery in the past and was suspected of having severe chest adhesions; The nodule puncture path has bony structure block; Others conditions that the investigator considers not appropriate for this trial.

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bronchoscopic ICG localization<br>The nodule will be located preoperatively by ENB-Guided bronchoscopic ICG injection; During the VATS operation, a near-infrared fluorescence thoracoscopy will be used to identify ICG distribution in the visceral pleura to guide an accurate surgical resection. | Device: Indocyanine green (ICG)<br>* Indocyanine green (ICG) was diluted with saline to 0.5mg/mL, and injected 0.6mL/site.<br>Device: Electromagnetic navigation bronchoscopy<br>* Electromagnetic navigation bronchoscopy (ENB) allows physicians to access peripheral lung nodules with high accuracy and provides a working channel for ICG injection.<br>|
| Active Comparator: percutaneous hook-wire localization<br>The nodule will be located preoperatively by percutaneous placement of hook wire; During the VATS operation, the resection scope is determined by the location relationship between hook wire and the nodule under CT scan. | Device: Hook wire<br>* Hook wire is a puncture locating needle with a hook head that is about 1 cm in length and 30 cm metal wire behind. Through the puncture path planned based on CT scan, hook wire puncture percutaneously into the chest cavity to reach the lesion for localization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the localization procedure | Calculated as follows: (number of successful targeting procedures/number of all localization procedures)*100 | On the 1 day of localization operation | 
| Success rate of the effective localization | Calculated as follows: [(number of successful targeting procedures-number of dislodgements or unrecognized in the operative field)/number of all localization procedures]*100 | On the 1 day of VATS operation | 
| Success rate of VATS sublobar resection | Calculated as follows: (number of successful VATS procedures/number of all localization procedures)*100 | On the 1 day of VATS completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoint | Complication rate of two localization methods, including pneumothorax, hemorrhage, etc. | On the 1 day of VATS operation | 
| Localization time | The localization time of the control group was defined as the time from the first CT scan which set the path for percutaneous puncture, to the last CT scan which confirmed the hook wire located at the expected site. The localization time of the experimental group was defined as the time from the insertion of bronchoscope to the glottis, to the withdrawal of bronchoscope from the glottis after ICG injection. | On the 1 day of localization operation | 
| Operation time of VATS sublobar resection | The operation time is defined as the time from the start of the skin incision to the completion of the suture of the skin. | On the 1 day of VATS completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electromagnetic navigation bronchoscopy (ENB), localization, Lung cancer, Video-associated thoracic surgery, Indocyanine green (ICG)