Combined Endoscopic-laparoscopic Sentinel Lymph Node Navigation Surgery in Early Gastric Cancer

Launched by BEIJING FRIENDSHIP HOSPITAL · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new surgical approach called combined endoscopic-laparoscopic sentinel lymph node navigation surgery for patients with early gastric cancer (EGC). This method aims to help doctors better identify and treat the cancer while minimizing the need for more extensive surgery. The trial is especially important because it aims to gather evidence about the safety and effectiveness of this technique specifically in Chinese patients, as previous studies have not focused on this population.

To participate in this trial, you need to be between 18 and 80 years old, physically fit enough for surgery, and have certain types of early gastric cancer. This means you should not have had prior surgeries, chemotherapy, or radiation treatment for this condition. Participants will undergo the new surgical technique and will be closely monitored for safety and outcomes. If you're interested in learning more or think you might qualify, it's a great opportunity to contribute to important research that could help others facing similar health challenges.

Gender

ALL

Eligibility 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 cT1NxM0 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.