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Recruiting
NCT05720598
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer
Conditions: Gastric Cancer, Lymph Node Metastasis
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 190
Sponsor: Medical University of Lublin
Location: Poland
Summary
Staging LaParscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA) study aims to investigate the safety and feasibility of ICG-guided SN retrieval in GC patients undergoing multimodal treatment.
The pretreatment clinical variables potentially associated with the procedure will also be analyzed.To the best of our knowledge, the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 yearsHistologically 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 classificationQualification for SL by the decision of the multidisciplinary tumor boardWritten informed consent for endoscopy and SLExclusion Criteria:Early GC (cT1N0-3M0) scheduled for endoscopic treatment by the multidisciplinary tumor boardPrevious abdominal surgery which could interfere lymphatic basin of the stomach, including previous gastrectomy, endoscopic (sub)mucosal dissectionDistant metastasis (cM1) clinically apparent in pretreatment abdominal/pelvic CTTechnical inability to perform endoscopic ICG injection or ICG injection beyond the submucosaVisual inability to identify the SN during SLPositive cytology (cyt+) after SLOther malignanciesHistory of allergy to iodine agents
Source: ClinicalTrials.gov (NCT05720598). StuddyBuddy aggregates publicly available trial information.