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Phase 3
Age: 18Years - 75Years
All Genders
ID06161207

Safety and Effectiveness of Indocyanine Green Imaging in Advanced Gastric Cancer Surgery Using 3D and Ultra High Resolution Laparoscopy

Led by Fujian Medical University · Updated on 2024-06-24

702

Participants Needed

1

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating patients with locally advanced gastric adenocarcinoma CT2-4a N- M0 to study the safety, effectiveness, and feasibility of using indocyanine green ICG near-infrared imaging tracing during 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer. This prospective, single-center, randomized controlled trial compares three surgical approaches to determine if the addition of ICG imaging and 3D visualization improves outcomes, focusing on disease-free survival over three years. Participants will be randomly assigned to one of three groups Group A receives ICG near-infrared imaging with 3D plus ultra high resolution laparoscopic gastrectomy and lymph node dissection Group B receives ICG imaging with ultra high resolution laparoscopic gastrectomy and lymph node dissection Group C undergoes 3D laparoscopic gastrectomy with lymph node dissection without ICG. The study plans to enroll 702 patients and follow them from surgery up to three years to assess long-term outcomes. During the study, patients will undergo surgery according to their assigned group, and researchers will collect data on operation time, number and status of lymph nodes removed, postoperative recovery, complications, immune response, nutritional status, quality of life, and survival rates. Follow-up includes pathology reports shortly after surgery and regular assessments over three years to measure disease-free survival and overall health. The study will also monitor secondary outcomes related to lymph node analysis and patient recovery.

CONDITIONS

Brief Title

3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer

Research Team

M

Mi Lin

H

Hua-Long Zheng

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