The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.
The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
312
Patients without prior ESD received ESD with laparoscopic sentinel basin dissection (LSBD) for ESD resectable lesions, otherwise patients received laparoscopic-endoscopic cooperative regional gastrectomy (LRG) with LSBD. For patients with prior non-curative ESD, LSBD alone was performed if margins were negative, otherwise LRG with LSBD was conducted. Intraoperative frozen-section pathological examination of the horizontal resection margin of the ESD or full-thickness specimen. During laparoscopic sentinel node basin dissection (LSBD), indocyanine green (ICG) (2 mL, 2.5 mg/mL) was endoscopically injected into the submucosal layer at four quadrants around the marking points (0.5 mL per quadrant). Fifteen minutes after ICG injection, sentinel lymph node basins (SLBs) were defined as the area within a 2 cm margin of the detected fluorescence stained nodes, which were marked with laparoscopic clips.
Preparation: The patient is positioned supine with general anesthesia. An orogastric tube and Foley catheter are inserted. Antibiotics are administered, and sequential stockings are applied. Port Placement: Pneumoperitoneum is created via a Veress needle at the umbilicus. Working ports are placed in the upper quadrants, with a fifth port for liver retraction. Abdominal Exploration: The abdomen is inspected for metastases, and peritoneal cytology is performed. Dissection and Lymph Node Removal: The lesser omentum is divided near the liver, reaching the cardia and diaphragm. The gastrocolic ligament is divided along the transverse colon. Lymph node dissection begins along the splenic artery, then proceeds to the left gastric artery and celiac nodes. The left gastric vessels are controlled with endoclips.After lymph node dissection, distal subtotal gastrectomy is performed. Digestive tract reconstruction is typically done through a mini-laparotomy.
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITING3 and 5-year disease free survival
Time frame: From treatment to 3 and 5-years after surgery
5-year overall survival
Time frame: From treatment to 5-years after surgery
Mortality (within 30 days after surgery);Unscheduled second surgery (within 30 days after surgery) and Unplanned return to hospital (within 30 days after surgery)
Time frame: From treatment to 30-days after surgery
rate of inconsistent result between intraoperative rapid pathology and postoperative pathology examine;Rates of remedial and additional surgery
Time frame: From enrollment to 1 week after surgery
Perioperative complication rate (within 30 days after surgery, including bleeding, perforation, lymphatic leakage, respiratory complications, cardiovascular complications, anastomotic fistula
According to the Clavien-Dindo scale, if the postoperative complication grade is higher than grade II, it is considered clinically significant)
Time frame: From treatment to 30-days after surgery
Operation time
Time frame: From treatment to 1 week after surgery
R0 resection rate
Time frame: From treatment to 1 week after surgery
additional surgical operation rate
Time frame: From treatment to 5-years after surgery
blood loss
Time frame: From treatment to 30-days after surgery
postoperative length of stay
Time frame: From treatment to 30-days after surgery
overall hospitalization cost
Time frame: From treatment to 5-years after surgery
Gastric emptying scintigraphy result
Time frame: From treatment to 5-years after surgery
date of gas evacuation
Time frame: From treatment to 30-days after surgery
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