Surgery to navigate lymph nodes in early gastric cancer
Official title: Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial Study
Run by Beijing Friendship Hospital · NCT06788548 · Data updated 2026-11-12
This study is testing a new type of surgery to see if it can safely help people with early gastric cancer who can't have standard treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 312 (estimated) |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | February 3, 2024 |
| Main results expected | November 1, 2029 |
| Study ends | December 30, 2029 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT06788548 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 18-80 with early gastric cancer who are eligible for curative D2 gastrectomy and meet specific health criteria.
✕Probably not a fit
Patients with prior gastrointestinal surgery, uncontrolled diseases, or contraindications for gastroscopy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the safety and efficacy of combined endoscopic-laparoscopic sentinel lymph node navigation surgery for patients with early gastric cancer. The approach aims to improve treatment outcomes for patients who do not meet the criteria for standard procedures like endoscopic submucosal dissection or radical gastrectomy. By utilizing advanced surgical techniques, the study seeks to establish a new standard of care for patients in China with early gastric cancer. The trial will include patients aged 18-80 who are candidates for curative surgery and have specific health criteria.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more effective treatment option for patients with early gastric cancer.
How similar studies have gone: Previous studies have suggested the potential of this combined surgical approach, but evidence-based validation in the Chinese population is currently lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\) Patients aged 18-80 years, regardless of gender. 2) Patients with Eastern Cooperative Oncology Group (ECOG) score ≤ 2 and American Society of Anesthesiologists (ASA) score ≤ 2 who are candidates for a curative D2 gastrectomy. 3\) Patients without prior gastrointestinal surgery, chemotherapy, or radiotherapy. 4\) Patients with normal liver, kidney, heart, lung, and bone marrow function (GPT × 109 /L, PLT\>109 /L). 5\) Patients capable of understanding and adhering to the research protocol. 6) Patients who can provide written informed consent, either personally or through legal representative. 7\) Patients with cT1N0M0 gastric cancer or after non-curative ESD resection, according to the UICC TNM staging system, 8th edition. Exclusion Criteria: * 1\) Patients with a contraindication for gastroscopy. 2) Patients with uncontrollable diseases, such as coagulation disorders, epilepsy, central nervous system diseases or mental disorders, cardiopulmonary insufficiency, unstable angina, myocardial infarction, a cerebrovascular accident that occurred within 6 months, and other surgical contraindications. 3\) Patients unable to undergo general anesthesia or surgical treatment due to conditions related to other organs, or unwilling to undergo surgery. 4\) Patients with gastric stump cancer, recurrent gastric cancer, multiple primary malignant tumors in the abdominopelvic cavity, or a history of other malignant tumors within the previous 5 years. 5\) Pregnant or lactating women. 6) Participants enrolled in other clinical trials. 7) Patients with undeterminable tracer staining range or contraindications to tracer use. 8\) Patients who fail to receive or fail ESD therapy. 9) Patients who meet the absolute indication of ESD.
Where it's running
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Zheng Zhi, Doctor
- Email: zhengzhi@ccmu.edu.cn
- Phone: +86-010-18311002896
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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SPADE procedure for upper stomach cancer
A multicenter study will test the SPADE operation, a special stomach reconnection technique, in patients with early upper-stomach cancer undergoing proximal gastrectomy to see if it is safe and feasible.
-
LECS with sentinel node navigation for early gastric cancer
This study tests whether combining LECS with sentinel node navigation can treat early gastric cancer while preserving stomach function in eligible patients.
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Image-guided platform helps find sentinel lymph nodes in early gastric cancer
This study tests whether an image-guided platform with a deep learning model can find and retrieve sentinel lymph nodes better than standard palpation in people with early gastric cancer undergoing LECS-SNNS.
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Early Gastric Cancer in China: Real-World Outcomes by Treatment Type
This project will look at real-world outcomes for about 5,000 Chinese patients with early gastric cancer treated with endoscopic resection, laparoscopic surgery, open surgery, or a combined approach to see how treatments relate to survival and recurrence.
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H. pylori status and tissue features to predict gastric cancer behavior after endoscopic treatment
This study tests whether current H. pylori infection status and tissue features can help predict how early gastric cancer will behave after endoscopic treatment.
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Dual-endoscope Sentinel Lymph Node Navigation for Early Gastric Cancer
This study tests whether using two endoscopes to guide sentinel lymph node navigation during laparoscopic surgery is safe and effective for people with early gastric cancer who need additional surgery after initial endoscopic treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.