RecruitingPhase 3NCT06755554

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


Sponsor

Ukrainian Society of Clinical Oncology

Enrollment

105 participants

Start Date

Jan 1, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether using a fluorescent dye called indocyanine green (ICG) during surgery helps surgeons better visualize and preserve lymphatic tissue, potentially reducing the amount of lymph node tissue removed during stomach cancer surgery. **You may be eligible if...** - You are 18–80 years old with stomach (gastric) adenocarcinoma (any subtype) - Your tumor is located in the stomach (not spread to nearby structures) - You are in good health (ECOG 0–1) - You have not had prior chemotherapy, surgery, or radiation for another cancer in the last 5 years - You are scheduled for surgery as part of your cancer treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic disease) - You are over 80 or under 18 years old - You have severe health conditions that make laparoscopic surgery unsafe - You refused to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEndoscopic injection of Indocyanine green

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)

National Cancer Institute

Kyiv, Ukraine

National Cancer Institute

Kyiv, Ukraine

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NCT06755554


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