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

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

Recruiting
18-80 years
All
Phase N/A

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Overview

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. Combined endoscopic-laparoscopic sentinel node navigation surgery seems to be the promising solution according to previous study, however evidence-based medicine in China was lacking. It is imperative to establish its safety and efficacy in Chinese patients with EGC.

Eligibility

Inclusion Criteria:

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  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.
  2. Patients without prior gastrointestinal surgery, chemotherapy, or radiotherapy.
  3. Patients with normal liver, kidney, heart, lung, and bone marrow function (GPT × 109 /L, PLT>109 /L).
  4. Patients capable of understanding and adhering to the research protocol. 6) Patients who can provide written informed consent, either personally or through legal representative.
  5. Patients with cT1NxM0 gastric cancer or after non-curative ESD resection, according to the UICC TNM staging system, 8th edition.

Exclusion Criteria:

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  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.
  2. Patients unable to undergo general anesthesia or surgical treatment due to conditions related to other organs, or unwilling to undergo surgery.
  3. 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.
  4. Pregnant or lactating women. 6) Participants enrolled in other clinical trials.
  5. Patients with undeterminable tracer staining range or contraindications to tracer use.
  6. Patients who fail to receive or fail ESD therapy. 9) Patients who meet the absolute indication of ESD.

Study details
    Early Gastric Cancer

NCT06788548

Beijing Friendship Hospital

4 September 2025

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