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

Study acronym: FLECSS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Beijing Friendship Hospital

Record History

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  1. Primary endpoint(s) modified
    • Secondary endpoints: 12 to 35
    v5
  2. Study title expanded, about 2 wordsv4
  3. Study completion date: Dec 31, 2029 to Dec 30, 2029
    • Start date: Jul 20, 2024 to Feb 3, 2024
    v3
  4. Primary endpoint revisedv2 Show 5 more changesShow less
    • Interventions: Laparoscopic D2 radical gastrectomy (Procedure), combined endoscopic-laparoscopic sentinel lymph node navigation surgery (Procedure) to Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery (Procedure), Laparoscopic D2 radical…
    • Eligibility criteria revised
    • Study description expanded, about 99 words
    • Collaborators expanded, about 10 words
    • Study title expanded, about 3 words
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06788548
Lead Sponsor Beijing Friendship Hospital
Collaborators: China-Japan Friendship Hospital, Cancer Hospital Chinese Academy of Medical Scienc
Conditions
(from sponsor)		 Early Gastric Cancer
Related terms Stomach Neoplasms
Enrollment 312 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov