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NCT Number: NCT07615374

Laparoscopic-endoscopic Surgery Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer

This study is to evaluate the safety and efficacy of dual-endoscope assisted sentinel lymph node navigation surgery for early gastric cancer (EGC).

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Key information

Conditions

Early Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Hospital of Jilin University, Changchun, Jilin, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preoperative assessment indicating that the tumor was confined to the mucosa or submucosa, consistent with the diagnosis of early gastric cancer.
  • Patients who required additional surgical intervention following initial endoscopic submucosal dissection (ESD) based on postoperative pathological evaluation.
  • Patients and their families fully understood the procedure, requested dual-endoscope assisted sentinel lymph node navigation surgery, agreed to participate in this clinical study, and signed the informed consent form.

Exclusion criteria

  • Preoperative assessment indicating suspected lymph node or distant metastasis.
  • History of complex abdominal surgery rendering laparoscopic treatment infeasible.
  • Participation in another clinical trial within 4 weeks prior to enrollment or currently participating in another trial.
  • History of severe psychiatric disorders.
  • Pregnant or lactating women.
  • Uncontrolled infection prior to surgery.
  • Presence of other malignancies or comorbidities that may significantly affect survival.
  • Any other conditions deemed by the investigators as unsuitable for participation, or refusal by the patient or family to enroll.
  • Cardiopulmonary, hepatic, and renal functions were unsufficient to tolerate the surgery.

Treatment and study plan

Laparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation Surgery

Procedure

After preoperative assessment and confirmation of eligibility, patients received general anesthesia with endotracheal intubation. Indocyanine green (ICG) was injected submucosally around the lesion in four quadrants to trace the sentinel lymph node (SLN) basin. Laparoscopic marking of the SLN basin was performed. Endoscopy assisted laparoscopy in marking the primary lesion border (ensuring a margin of >0.5 cm). Laparoscopic sentinel lymph node dissection was performed, followed by endoscopic/laparoscopic full-thickness resection of the lesion. Gastric wall defects were closed laparoscopically. SLNs were harvested and sent for intraoperative frozen section pathology. If positive, a standard radical gastrectomy was performed; if negative, an abdominal drainage tube was placed to complete the procedure.

Primary outcomes

  1. Incidence of perioperative complications.

    Time frame: One month after surgery

    Postoperative complications comprised hemorrhage, obstruction, gastrointestinal motility disorders, and fistulas. The overall complication rate was calculated as the number of patients with complications divided by the total number of patients in the cohort.

Secondary outcomes

  1. Number of retrieved lymph nodes.

    Time frame: One week after the surgery.

    The number of lymph nodes retrieved from all resected specimens.

Other outcomes

  1. the number of postoperative hospital stay in days.

    Time frame: One month after the surgery.

    Time from surgery to discharge was recorded in days.

  2. the number of time to first resumption of liquid diet in days

    Time frame: One month after surgery.

    Time to first resumption of liquid diet was recorded in days.

  3. R0 resection rate

    Time frame: One month after surgery.

    The R0 resection rate was defined as the proportion of patients with histopathologically confirmed complete resection and negative margins among all enrolled patients.

  4. the total number of Hospitalization costs in Chinese Yuan (CNY).

    Time frame: One month after surgery.

    Total hospitalization costs were calculated in Chinese Yuan (CNY).

  5. Number of patients requiring further therapy

    Time frame: Three month after surgery.

    Number of patients requiring further therapy (e.g., standard radical gastrectomy or chemotherapy).

  6. the rate of positive cytological examination results of peritoneal lavage fluid.

    Time frame: One week after surgery.

    Cytological examination of the irrigation fluid from the surgical field was performed postoperatively. A finding of tumor cells was considered positive.

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Jilin University

Other

Registry information

Official study title

A Prospective Registry Study of Laparoscopic-endoscopic Cooperative Surgery Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 29, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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