Surgery to navigate lymph nodes in early gastric cancer
Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06788548 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with prior gastrointestinal surgery, uncontrolled diseases, or contraindications for gastroscopy may not benefit from this study.
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 performed: Previous studies have suggested the potential of this combined surgical approach, but evidence-based validation in the Chinese population is currently lacking.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.