Actively Recruiting
Investigation of Effect of Indocyanine Green on Volume of Lymph Node Dissection in Surgical Treatment of Gastric Cancer
Led by Ukrainian Society of Clinical Oncology · Updated on 2025-03-30
105
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of indocyanine green (ICG) to improve the removal of lymph nodes during surgery for gastric cancer. This study focuses on patients with resectable gastric adenocarcinoma at stages Ib, II, and III. The goal is to assess the safety and benefits of using ICG in lymph node dissection, which may help achieve more complete removal of affected lymph nodes and potentially improve patient outcomes. The study is a prospective, open-label trial conducted at a single center. All participants will receive total or subtotal gastrectomy with systematic lymphadenectomy classified as D1, D1+, D2, or D2+. Before surgery, ICG is injected by endoscopic submucosal injection at four points around the tumor between 12 and 24 hours prior to the operation. During surgery, fluorescent lymph nodes labeled by ICG will be identified, removed, and mapped. The injection procedure is performed under general anesthesia, with a total ICG dose of up to 20 mg. Participants will be monitored before and after surgery for side effects related to ICG and surgical complications. Postoperative complications will be classified using Clavien-Dindo criteria. The primary outcome is the average number of lymph nodes removed during surgery, measured 30 days after the operation. Secondary outcomes include the number of fluorescent and metastatic lymph nodes and the incidence of complications within 90 days. Patients will receive standard postoperative care, including gradual resumption of fluids and physical activity, with follow-up lasting three months after surgery.
CONDITIONS
Brief 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
- No distant metastases (cM0)
- Age between 18 and 80 years
- Men and women
- ECOG performance status 0 to 1
- Histologic type: adenocarcinoma of any subtype
- Degree of tumor differentiation: G1 to G4
- Tumor located in cardiac region, stomach floor, body, antrum, pylorus, or pyloric region
- No invasion of the tumor into adjacent structures
- No history of cancer in the past 5 years
- No prior chemotherapy, surgery, or radiation for another cancer (except neoadjuvant chemotherapy for gastric cancer)
- Absence of severe comorbidities limiting 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
- Presence of severe comorbidities classified as ASA greater than 3
- Patient refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 to 24 hours before surgery
Participants receive an endoscopic injection of indocyanine green into 4 points around the tumor 24 to 12 hours before surgery to assist in lymph node mapping.
1 visit (in-person)
Duration - Day of surgery
Participants undergo radical gastrectomy with lymph node dissection guided by fluorescence imaging from indocyanine green to remove lymph nodes and tumor tissue.
1 surgical visit (in-person)
Duration - Up to 90 days after surgery
Participants are monitored for postoperative complications and recovery including assessments for side effects related to indocyanine green and surgical outcomes.
Multiple visits during 90 days post surgery
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
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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