NCT06755554RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 24 Dec 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Ukrainian Society of Clinical Oncology
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06755554
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 105
- From 1 Jan 2025 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age over 80 and under 18;
Other
- M1 (distant metastases);
- ECOG 2 - 4;
- Presence of severe comorbidities, ASA\> 3;
- Patient refusal to participate in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Institute Coordinator of this site? Confirm its status | Kyiv | Ukraine | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.