Actively Recruiting
Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer（IDEAL Stage 2b）
Led by Beijing Friendship Hospital · Updated on 2026-05-11
312
Participants Needed
1
Research Sites
308 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
The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.
CONDITIONS
Official 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 through a legal representative
- Diagnosed with cT1N0M0 gastric cancer or after non-curative ESD resection according to UICC TNM staging system, 8th edition
You will not qualify if you...
- Contraindication for gastroscopy
- Uncontrollable 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 to undergo general anesthesia or surgery due to other organ conditions or unwillingness to have surgery
- Gastric stump cancer, recurrent gastric cancer, multiple primary malignant tumors in abdominopelvic cavity, or history of other malignant tumors within 5 years
- Pregnant or lactating women
- Participation in other clinical trials
- Undeterminable tracer staining range or contraindications to tracer use
- Failure to receive or failure of ESD therapy
- Meeting absolute indication criteria for ESD
AI-Screening
AI-Powered Screening
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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
CONTACT
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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