Fluorescence Image-Guided Lymphadenectomy in Robotic Gastrectomy (IG-MIG)
Gastric Cancer, Sentinel Lymph Node
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Robotic surgery, fluorescence, indocyanine green, lymphadenectomy
Eligibility Criteria
Inclusion Criteria:
- diagnosis of gastric cancer proved through the endoscopic biopsy
- cT1 - cT3
- cN0
Exclusion Criteria:
- history of allergies related to iodine
- pregnancy
- cT4,
- cN +
- distant metastases
- estimated sizes > 4cm
- synchronous malignant tumors in other organs
- ASA score ≥ 4
Sites / Locations
- Ospedale di Forlì "G.B. Morgagni" - AUSL della Romagna - U.O.C. di Chirurgia e Terapie Oncologiche Avanzate
- Azienda Ospedaliera di Terni "Santa Maria" - S.C. di Chirurgia DigestivaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Image-Guided Robotic Gastrectomy
Robotic Gastrectomy
The day before surgery, the ICG will be injected endoscopically into the submucosa of the four quadrants around the tumor (1.25mg/mL, 0.6mL x 4). A modified total D2 gastrectomy - including the following lymph node stations: 1 - 7 + 8a, 9, 11p, 12a - will be performed in each patient. The lymph node dissection will be performed using the Da Vinci Xi robotic system and the assistance of the near infrared technology to detect ICG fluorescence. Even the resulting fluorescent lymph nodes outside the standard dissection plane will be retrieved. The lymph node stations will be sent to the pathologist in different containers and further subdivided according to fluorescence.
Data from patients undergoing the same surgery without the ICG imaging procedure will be collected during the same study period.