Subpleural lymphatic flow in lung cancer

JRCT ID: jRCTs051230188

Registered date:22/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small-cell lung cancer
• Date of first enrollment: 22/02/2024
• Target sample size: 49
• Study type: Interventional
• Intervention(s): During thoracoscopic lobectomy, once the chest cavity is open, indocyanine green (ICG) and autologousblood are injected around the tumor, and the optimal dose of ICG is determined so that the subplueral lympatic drainage pattway could be identified using near-infrared fluorescence imaging system (Experiment 1). After determing the optimal ICG dose, we investigate the direction of the lymphatic spread according to each tumor-located lobe (Experiment 2).

Outcome(s)

Primary Outcome

The evaluation of visualization and identification of subpleural lymphatic pathway using NIR imaging system.
The examination for the direction of lymphatic spread according to each tumor-located lobe.

Secondary Outcome

The evaluation of identification of fluoreseced lobe-specific mediastinal lymph node on NIR imaging system.
The rate of adverse event during follow-up period

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. Primary lung cancer patients who will receive thoracoscopic lobectomy.
2. The tumor located in the outer one-third of lung field.
3. The patints with 18 years old or more, and 79 years old or less
4. The patients having provided signed informed consent.

Exclude criteria

1. The patients who are allergic to iodine.
2. The patients who will receive middle lobe lobectomy
3. The pregnant patients.
4. The patients who are judged to be eligible by investigators.

Related Information

• Primary Sponsor: Tane Shinya