Evaluation of the efficacy and safety of ICG Fluorescence navigation surgery

JRCT ID: jRCTs041220017

Registered date:18/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer/ esophageal cancer
• Date of first enrollment: 29/07/2022
• Target sample size: 310
• Study type: Interventional
• Intervention(s): A small volume of the dilluted ICG solution was injected into submucosa using gastrointesitinal endoscopy

Outcome(s)

• Primary Outcome: Evaluate the number of lymph node dissections
• Secondary Outcome: Operative time, amount of blood loss, organ damage, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 Patients who were diagnosed with gastric cancer or esophageal cancer(StageI-III)
2 Over 20 years old
3 Patients determined to be ready for general anesthesia and surgery
4 Performance Status (ECOG) 0 or 1
5 Objective procedure: Thoracoscopic esophagectomy, laparoscopic gastrectomy (including robot-assisted surgery)
6 Historical control: Patients who received surgery in Kanazawa University Hospital from January 2018 to
October 2021(StageI-III)
7 Patients for whom informed consents were taken

Exclude criteria

1 History of hypersensitivity to ICG
2 Hypersensitivity to iodine
3History of asthma or drug allergy
4 Judged to be difficult to participate in the study because of mental disorder
5 Inappropriate case determined by the principal invstigator/researcher

Related Information

• Primary Sponsor: Inaki Noriyuki