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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo laparoscopic gastrectomy with lymph node dissection using one of the assigned techniques, including the use of Indocyanine Green tracer in some groups for imaging.
1 surgery visit and hospital stay for immediate recovery
Duration - 30 days
Participants are monitored for recovery, complications, nutritional status, immune response, and quality of life after surgery.
Approximately 6 post-operative visits
Duration - 3 years
Participants are followed to assess disease-free survival, recurrence patterns, overall survival, and quality of life up to three years after surgery.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
M
Mi Lin
H
Hua-Long Zheng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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