Clinical Study on Using Laparoscopic Sentinel Lymph Node Navigation Combined With Dual Endoscopy Surgery for Early Gastric Cancer

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Enrollment reduced 70% 30 → 9 participants
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Record History

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  1. Notable Enrollment reduced: 30 → 9 participants Show 6 more changesShow less
    • Trial status changed: Enrolling by Invitation → Recruiting
    • Interventions modified
    • Study sites: 1 to 2
    • Start date: Jan 1, 2026 to Jan 8, 2026
    • Eligibility criteria expanded, about 64 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Minor Study First Submitted
  • 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.
1,281 trials monitored
See 61 trials at risk
Gastric cancer is a common malignant tumour worldwide, and in China, the incidence and mortality rates of gastric cancer remain high. Standardised surgical treatment is effective, but the normal structure of the stomach undergoes irreversible changes, leading to a series of adverse reactions. At the same time, some early-stage gastric cancer patients cannot have the lesions completely removed endoscopically, and conventional surgery can affect postoperative normal life. Therefore, laparoscopic and endoscopic cooperative surgery has become a focus for precise stomach-preserving surgery. Participants meeting the surgical criteria are selected, and after discussing the treatment plan with their families and signing informed consent forms, relevant examinations are completed. During surgery, lesions are explored together using laparoscopy and endoscopy, then a fluorescent tracer is injected around the lesion and the lesion boundary is marked. Fifteen minutes after injecting the fluorescent tracer, the illuminated perigastric lymph nodes are the sentinel lymph node region (SLNB), and all fluorescent lymph nodes (sentinel lymph nodes) are removed and sent for intraoperative frozen pathology. If the SLNB is negative: a dual-endoscope combined local gastric resection (endoscope combined with laparoscopic local gastric resection or a modified procedure) is performed to completely remove the lesion, ensuring a negative margin. If the SLNB is positive: immediate conversion to laparoscopic-assisted radical gastrectomy (D2 lymph node dissection) is carried out. For SLNB-negative cases, the dual-endoscope combined local gastric resection specimen is placed in a retrieval bag for full removal and examination, with the stomach wall incision then closed by suturing or using a stapler. Postoperative follow-up includes monitoring tumour outcomes and quality of life.
Trial Details
NCT Number NCT07708012
Lead Sponsor wangdongsheng
Conditions
(from sponsor)
Early-stage Upper Gastrointestinal Cancer, Stomach Cancer, Adenocarcinoma, Laparoscopy-assisted Surgery, Endoscope
Related terms Adenocarcinoma, Gastrointestinal Neoplasms, Stomach Neoplasms
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov