Using indocyanine green to improve lymph node removal in gastric cancer surgery
Investigation of Effect of Indocyanine Green on Volume of Lymph Node Dissection in Surgical Treatment of Gastric Cancer
This study is testing if a special dye called indocyanine green can help surgeons find and remove more lymph nodes during gastric cancer surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ukrainian Society of Clinical Oncology Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Kyiv and 1 other locations) |
| Trial ID | NCT06755554 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of indocyanine green (ICG) in enhancing lymph node dissection during surgery for resectable gastric cancer. Patients will receive an endoscopic injection of ICG prior to surgery, which will help identify lymph nodes more effectively during the procedure. The primary goal is to assess the average number of lymph nodes removed, while secondary outcomes include the identification of ICG-positive lymph nodes and monitoring for postoperative complications. All eligible patients will undergo total or subtotal gastrectomy with varying degrees of lymphadenectomy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with resectable gastric adenocarcinoma and no distant metastases.
Not a fit: Patients with distant metastases or severe comorbidities that restrict surgical options may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more thorough lymph node removal, potentially improving survival rates for gastric cancer patients.
How similar studies have performed: Previous studies have shown promising results with similar approaches using indocyanine green in other types of cancer surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Kyiv and 1 other locations
- National Cancer Institute — Kyiv, Ukraine (Not_yet_recruiting)
- National Cancer Institute — Kyiv, Ukraine (Recruiting)
Study contacts
- Study coordinator: Oleksii Dobrzhanskyi, MD
- Email: oleksii.dobrzhanskyi@unci.org.ua
- Phone: +380638760185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.