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

NCT07615374 — Not applicable, Recruiting, 36 participants, Jilin University

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

RegistryNCT07615374
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment36 (Estimated)
SponsorJilin University (Other)
ConditionsEarly Gastric Cancer
InterventionsLaparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation Surgery (Procedure)
Datesstart 2026-05-12, primary completion 2028-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2026-05-29, last updated 2026-09-14
Locations2 sites in China

Related Papers Related Patents Related Grants Related Experts
All trials for Early Gastric Cancer All trials of Laparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation Surgery

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Sentinel Lymph Node Navigation SurgeryExperimentalProcedure: Laparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation SurgeryLaparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer
  • 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.

+Outcome measures

Primary outcomes

  • 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.

Secondary outcomes

  • Number of retrieved lymph nodes. [One week after the surgery.]: The number of lymph nodes retrieved from all resected specimens.

Other outcomes

  • the number of postoperative hospital stay in days. [One month after the surgery.]: Time from surgery to discharge was recorded in days.
  • the number of time to first resumption of liquid diet in days [One month after surgery.]: Time to first resumption of liquid diet was recorded in days.
  • R0 resection rate [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.
  • the total number of Hospitalization costs in Chinese Yuan (CNY). [One month after surgery.]: Total hospitalization costs were calculated in Chinese Yuan (CNY).
  • Number of patients requiring further therapy [Three month after surgery.]: Number of patients requiring further therapy (e.g., standard radical gastrectomy or chemotherapy).
  • the rate of positive cytological examination results of peritoneal lavage fluid. [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.

+Eligibility

Sex: All

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.

+Locations (2)

FacilityCityCountryStatus
the First Hospital of Jilin UniversityChangchun, JilinChinaRecruiting
the First Hospital of Jilin UniversityCh’ang-ch’un, JilinChinaActive not recruiting