Actively Recruiting
Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial Study
Led by Beijing Friendship Hospital · Updated on 2026-05-11
312
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
B
Beijing Friendship Hospital
Lead Sponsor
C
China-Japan Friendship Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating treatments for early gastric cancer (EGC), focusing on improving surgical methods to preserve stomach function and enhance quality of life. The study compares traditional radical gastrectomy with sentinel node navigation surgery (SNNS), which allows limited lymph node removal and may support function-preserving gastrectomy. This research aims to establish the safety and effectiveness of SNNS and better understand postoperative outcomes in patients with EGC. The study involves two main surgical approaches. One group receives fluorescence-guided laparoscopic-endoscopic cooperative sentinel lymph node navigation surgery, which includes precise tumor localization and selective lymph node removal using a fluorescent dye. The other group undergoes laparoscopic D2 radical gastrectomy following established guidelines for extensive lymph node dissection. Preoperative scans and endoscopic techniques help define tumor location and guide surgery. Different surgical procedures are applied depending on prior treatments and tumor characteristics. Participants will be assessed through imaging, pathology exams, and clinical evaluations before, during, and after surgery. The study measures include disease-free survival at 3 and 5 years, overall survival, complication rates, operation details, and quality of life indicators such as gastric emptying and hospital stay length. Safety monitoring includes tracking mortality, reoperations, and hospital readmissions within 30 days. The study will follow participants for up to 5 years to evaluate long-term outcomes and costs associated with each surgical method.
CONDITIONS
Brief Title
Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer（IDEAL Stage 2b）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years, any gender
- Eastern Cooperative Oncology Group (ECOG) score of 2 or less and American Society of Anesthesiologists (ASA) score of 2 or less
- Candidates for curative D2 gastrectomy
- No prior gastrointestinal surgery, chemotherapy, or radiotherapy
- Normal liver, kidney, heart, lung, and bone marrow function
- Able to understand and follow the research protocol
- Able to provide written informed consent personally or via legal representative
- Diagnosed with cT1N0M0 gastric cancer or after non-curative endoscopic submucosal dissection (ESD) resection according to UICC TNM staging, 8th edition
You will not qualify if you...
- Contraindication for gastroscopy
- Uncontrolled diseases such as coagulation disorders, epilepsy, central nervous system diseases, mental disorders, cardiopulmonary insufficiency, unstable angina, recent myocardial infarction or cerebrovascular accident within 6 months
- Unable or unwilling to undergo general anesthesia or surgery due to other organ conditions
- Gastric stump cancer, recurrent gastric cancer, multiple primary malignant tumors in the abdomen or pelvis, or history of other malignant tumors within past 5 years
- Pregnant or lactating women
- Enrolled in other clinical trials
- Undeterminable tracer staining range or contraindications to tracer use
- Failure to receive or failure of endoscopic submucosal dissection therapy
- Meeting absolute indications for endoscopic submucosal dissection (ESD) only without need for study interventions
AI-Screening
AI-Powered Screening
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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 either Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery or Laparoscopic D2 radical gastrectomy as part of their treatment for early gastric cancer.
1 surgical visit (in-person)
Duration - Up to 5 years after surgery
Participants are monitored for complications, recovery progress, and surgical outcomes including disease-free survival and overall survival.
Multiple follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
Z
Zheng Zhi, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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