Early Gastric Cancer
Conditions
Keywords
Laparoscopic-endoscopic cooperative surgery, Sentinel Lymph Node Navigation, Early Gastric Cancer
Brief summary
This study is to evaluate the safety and efficacy of dual-endoscope assisted sentinel lymph node navigation surgery for early gastric cancer (EGC).
Interventions
PROCEDURELaparoscopic-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.
Sponsors
Jilin University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of retrieved lymph nodes. | One week after the surgery. | The number of lymph nodes retrieved from all resected specimens. |
Countries
China
Contacts
CONTACTQuan Wang, Professor
Outcome results
None listed