Actively Recruiting
Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer
Led by Ukrainian Society of Clinical Oncology · Updated on 2025-03-30
105
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tumor spread: cT2-4a cN0-3, cM0
- Age between 18 and 80 years
- Both men and women
- ECOG performance status 0 or 1
- Histologic type: Adenocarcinoma of any subtype
- Tumor differentiation grade G1 to G4
- Tumor located in cardiac region, stomach floor, body, antrum, pylorus, or pyloric region
- No tumor invasion into adjacent structures
- No cancer history in the past 5 years
- No previous chemotherapy, surgery, or radiation for another cancer (except neoadjuvant chemotherapy for gastric cancer)
- No severe comorbidities restricting laparoscopic surgery
You will not qualify if you...
- Presence of distant metastases (M1)
- ECOG performance status 2 to 4
- Age under 18 or over 80 years
- Severe comorbidities with ASA score greater than 3
- Patient refusal to participate in the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
National Cancer Institute
Kyiv, Ukraine, 03022
Not Yet Recruiting
2
National Cancer Institute
Kyiv, Ukraine, 03022
Actively Recruiting
Research Team
O
Oleksii Dobrzhanskyi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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