NCT04182152

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Jiayuan Sun · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Indocyanine green (ICG)	Indocyanine green (ICG) was diluted with saline to 0.5mg/mL, and injected 0.6mL/site.
DEVICE	Electromagnetic navigation bronchoscopy	Electromagnetic navigation bronchoscopy (ENB) allows physicians to access peripheral lung nodules with high accuracy and provides a working channel for ICG injection.
DEVICE	Hook wire	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.

Timeline

• Start date: 2019-11-05
• Primary completion: 2020-11-05
• Completion: 2020-12-05
• First posted: 2019-12-02
• Last updated: 2019-12-02

Locations

1 site across 1 country: China