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

Jiayuan Sun

Status: Unknown

Conditions: Lung Cancer

Treatments: Device: Indocyanine green (ICG); Device: Electromagnetic navigation bronchoscopy; Device: Hook wire

Study type: Interventional

Funder types: Other

Identifiers

NCT04182152

SHCHE201905

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Bronchoscopic ICG localization

Experimental group

Description:

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.

Treatment:

Device: Electromagnetic navigation bronchoscopy

Device: Indocyanine green (ICG)

percutaneous hook-wire localization

Active Comparator group

Description:

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.

Treatment:

Device: Hook wire