Significance of ICG fluorescence-guided navigation surgery

JRCT ID: jRCTs031210135

Registered date:09/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer, Esophagogastric junction cancer
• Date of first enrollment: 09/06/2021
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Endoscopic submucosal injection of ICG around tumor.

Outcome(s)

• Primary Outcome: Number of dissected lymph nodes.
• Secondary Outcome: Operation time, estimated blood loss, postoperative complication rate of Grade 3 or higher according to Clavien-Dindo classification, postoperative inflammatory findings (WBC/CRP), postoperative hospital stay, Number of pathological metastatic lymph nodes with ICG-positive dissected lymph nodes, Rate of pathological metastasis of ICG-fluorescent lymph nodes, Overall survival rate, Cancer-specific survival rate

Key inclusion & exclusion criteria

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

Include criteria

1. Patients with resectable gastric and esophagogastric junction cancer who have pathologically diagnosed of adenocarcinoma.
2. 20-years old and more, PS 0-2. Gender does not matter.
3. Consent to participate in the study and the patient or his / her representative has signed the ethics committee approval consent document.

Exclude criteria

1. Patients with active double cancer (simultaneous double cancer and metachronous double cancer with a disease-free period of up to 5 years).
2. Patients with a history of frequent laparotomy and expected to have a high degree of intra-abdominal adhesions.
3. Patients with a history of ICG or iodine hypersensitivity, asthma or severe drug allergies.
4. Patients with serious comorbidities.
5. Female patients of childbearing potential or breastfeeding.
6. Patients receiving continuous systemic steroids (oral or intravenous).
7. Patients with mental illness or psychiatric symptoms who are judged to be difficult to participate.
8. In addition, patients who are judged by the principal investigator to be inappropriate for participation in this study.

Related Information

• Primary Sponsor: Sano Akihiko