Actively Recruiting
Clinical Outcomes of Indocyanine Green Tracer in 3D Plus Ultra High Resolution Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer
Led by Fujian Medical University · Updated on 2024-06-24
702
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75 years
- Confirmed primary gastric adenocarcinoma by endoscopic biopsy
- Clinical stage cT2-4a, N-/+, M0 without distant metastasis
- No direct invasion of pancreas, spleen, or adjacent organs
- ECOG performance status of 0 or 1
- ASA class I to III
- Provided written informed consent
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Severe mental disorder
- Previous upper abdominal surgery except laparoscopic cholecystectomy
- Previous gastric surgery including ESD/EMR for gastric cancer
- Enlarged regional lymph node over 3 cm
- Other malignant disease within past 5 years
- Previous neoadjuvant chemotherapy or radiotherapy
- Unstable angina or myocardial infarction within past 6 months
- Cerebrovascular accident within past 6 months
- Continuous corticosteroid use within 1 month
- Need for simultaneous surgery for other diseases
- Emergency surgery due to gastric cancer complications
- FEV1 less than 50% of predicted value
- Diffuse invasive gastric cancer
- History of iodine allergy
- Patients who declined laparoscopic surgery
Research Team
M
Mi Lin
H
Hua-Long Zheng
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