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

NCT07615374 · tracked via the Priya Life Science China tracker

Sponsor

Jilin University

Phase

Not applicable

Started

2026-05-12

Last updated

2026-09-14

Condition(s) studied

Early Gastric Cancer

Investigational drug(s) / intervention(s)

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

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

Study summary

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

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of perioperative complications. — 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.

Trial sites (2)

Facility	City	Region	Status
the First Hospital of Jilin University	Changchun	Jilin	Recruiting
the First Hospital of Jilin University	Ch’ang-ch’un	Jilin	Active Not Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07615374 on ClinicalTrials.gov ↗ ← All trials in China