Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer(IDEAL Stage 2b)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Friendship Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery
  • Laparoscopic D2 radical gastrectomy

Treatment groups

312 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Friendship Hospital

Lead sponsor

China-Japan Friendship Hospital

Collaborator

Cancer Hospital Chinese Academy of Medical Scienc

Collaborator