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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Lymph Node Navigation Surgery | Experimental | Laparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of retrieved lymph nodes. | The number of lymph nodes retrieved from all resected specimens. | One week after the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| the number of postoperative hospital stay in days. | Time from surgery to discharge was recorded in days. | One month after the surgery. |
| the number of time to first resumption of liquid diet in days | Time to first resumption of liquid diet was recorded in days. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of Jilin University | Ch’ang-ch’un | Jilin | 130021 | China |
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|
| One month after surgery. |
| 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. | One month after surgery. |
| the total number of Hospitalization costs in Chinese Yuan (CNY). | Total hospitalization costs were calculated in Chinese Yuan (CNY). | One month after surgery. |
| Number of patients requiring further therapy | Number of patients requiring further therapy (e.g., standard radical gastrectomy or chemotherapy). | Three month after surgery. |
| the rate of positive cytological examination results of peritoneal lavage fluid. | Cytological examination of the irrigation fluid from the surgical field was performed postoperatively. A finding of tumor cells was considered positive. | One week after surgery. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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