Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer
Recruiting now · Phase 3
Conditions studied: Gastric Cancer Stage II, Gastric Cancer Stage III, Gastric Cancer, Gastrectomy for Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT06755554
- Run by
- Ukrainian Society of Clinical Oncology
- People needed
- 105
- Starts
- 2025-01-01
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2025-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- National Cancer Institute — Kyiv, Ukraine (enrolling)
- National Cancer Institute — Kyiv, Ukraine
Full record on ClinicalTrials.gov
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