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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJilin University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

    Procedure/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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Sentinel Lymph Node Navigation SurgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of perioperative complications.

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.

Time frame
One month after surgery

Secondary outcomes

1

Number of retrieved lymph nodes.

The number of lymph nodes retrieved from all resected specimens.

Time frame
One week after the surgery.

Other outcomes

1

the number of postoperative hospital stay in days.

Time from surgery to discharge was recorded in days.

Time frame
One month after the surgery.
2

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

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

Time frame
One month after surgery.
3

R0 resection rate

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

Time frame
One month after surgery.
4

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

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

Time frame
One month after surgery.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.