Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)
Gastric Cancer, Lymph Node Metastasis
About this trial
This is an interventional diagnostic trial for Gastric Cancer focused on measuring Gastric Cancer, ICG, Staging Laparoscopy
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma) Stage II - III disease (cT2-4a, N0-3, M0) based on the pretreatment CT and 8th edition of TNM classification Qualification for SL by the decision of the multidisciplinary tumor board Written informed consent for endoscopy and SL Exclusion Criteria: Early GC (cT1N0-3M0) scheduled for endoscopic treatment by the multidisciplinary tumor board Previous abdominal surgery which could interfere lymphatic basin of the stomach, including previous gastrectomy, endoscopic (sub)mucosal dissection Distant metastasis (cM1) clinically apparent in pretreatment abdominal/pelvic CT Technical inability to perform endoscopic ICG injection or ICG injection beyond the submucosa Visual inability to identify the SN during SL Positive cytology (cyt+) after SL Other malignancies History of allergy to iodine agents
Sites / Locations
- Medical University of LublinRecruiting
Arms of the Study
Arm 1
Experimental
Patients underdoing staging laparoscopy with indocyanine green (ICG)
Patients will undergo upper GI endoscopy one day before SL will be dissolved in sterile water, resulting in a 0.125mg/ml concentration. 2 milliliters of the solution will be injected into the submucosa of 4 peritumoral sites - 0.5ml for each site. The following day patient will undergo SL Intraoperative application of ICG-enhanced vision will be accomplished with dedicated optical devices. Alternate usage of white light and ICG fluorescence mode will allow precise location and cT stage determination of primary tumor, followed by identification of SN and its corresponding LN station, according to Japanese Gastric Cancer Association guidelines. Identified SN will be retrieved with a high-energy device, and the LN basin will be labeled with a magnetic clip.