Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer
Investigation of Effect of Indocyanine Green on Volume of Lymph Node Dissection in Surgical Treatment of Gastric Cancer
Ukrainian Society of Clinical Oncology
105 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
Summary
The study aims to evaluate the safety and benefits of using indocyanine green in lymph node dissection for gastric cancer surgery. The primary endpoint is the average number of lymph nodes removed. Secondary study points are the average number of ICG-positive lymph nodes; the average number of metastatic ICG-positive lymph nodes; the number of postoperative complications and complications associated with the administration of ICG. Patients who meet the inclusion criteria for this study will be enrolled in the study after reviewing and signing an informed consent form. All patients will be included in one group and will receive surgical treatment in the amount of total or subtotal gastrectomy with lymphadenectomy D1, D1+, D2 or D2+. ICG is injected by the patient by endoscopic submucosal injection into 4 points around the tumor 24-12 hours before the start of the surgical intervention. Assessment of the number of fluorescent lymph nodes will be performed intraoperatively with their subsequent removal and mapping. The incidence of postoperative complications will be assessed by Clavien-Dindo.
Eligibility
Inclusion Criteria12
- Tumor spread: cT2-4a cN0-3,
- cM0;
- Age: 18 - 80;
- Gender: men and women;
- ECOG: 0 - 1;
- Histologic type of tumor: Adenocarcinoma of any subtype;
- Degree of differentiation: G1 - G4;
- Tumor localization: cardiac region, stomach floor, stomach body, antrum, pylorus, and pyloric region of the stomach;
- Tumor spread: absence of tumor invasion into adjacent structures;
- No history of cancer in the last 5 years;
- No previous chemotherapy, surgery or radiation treatment for another cancer (except for neoadjuvant chemotherapy for gastric cancer);
- Absence of severe comorbidity restricting laparoscopic approach.
Exclusion Criteria5
- M1 (distant metastases);
- ECOG 2 - 4;
- Age over 80 and under 18;
- Presence of severe comorbidities, ASA\> 3;
- Patient refusal to participate in the study.
Interventions
ICG is injected by the patient by endoscopic submucosal injection into 4 points around the tumor 24-12 hours before the start of the surgical intervention.
Locations(2)
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NCT06755554