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Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer

NCT06755554 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Gastric Cancer Stage II
  • Gastric Cancer Stage III
  • Gastric Cancer
  • Gastrectomy for Gastric Cancer

Interventions

DRUG

Endoscopic 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.

Sponsors & Collaborators

  • Ukrainian Society of Clinical Oncology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-01
Completion
2026-02-01

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06755554 on ClinicalTrials.gov