Significance of ICG fluorescence-guided navigation surgery
- Conditions
- Gastric cancer, Esophagogastric junction cancer
- Registration Number
- JPRN-jRCTs031210135
- Lead Sponsor
- Sano Akihiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of dissected lymph nodes.
- Secondary Outcome Measures
Name Time Method 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