The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.

Study Overview
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Brief Summary
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To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.

Official Title
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A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy for Gastric Cancer.

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Totally Laparoscopic Total Gastrectomy
* Procedure: Laparoscopy-Assisted Total Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-75 years； Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.； Clinical stage cT1N0M0, cT1N1M0, cT2N0M0； The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)； BMI(Body Mass Index)<30 kg/m2； No history of upper abdominal surgery (except for laparoscopic cholecystectomy)； No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.； Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1； Preoperative ASA (American Society of Anesthesiologists) scoring I-III； Sufficient vital organ functions； Signed informed consent. Exclusion Criteria: Preoperative examination indicates disease stage cStage II or above； Women during pregnancy or lactation； Suffer from other malignant tumors within 5 years； Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment； Severe mental illness； Severe respiratory disease； Severe liver and kidney dysfunction； History of unstable angina or myocardial infarction within 6 months； History of cerebral infarction or cerebral hemorrhage within 6 months； Continuous application of glucocorticoid within 1 month (except for topical application)； Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ； The patient has participated in or is participating in other clinical studies (within 6 months).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Totally Laparoscopic Total Gastrectomy<br>Totally laparoscopic total gastrectomy will be performed for the treatment of patients assigned to this group. | Procedure: Totally Laparoscopic Total Gastrectomy<br>* Totally laparoscopic total gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.<br>|
| Active Comparator: Laparoscopy-Assisted Total Gastrectomy<br>Laparoscopy-assisted total gastrectomy will be performed for the treatment of patients assigned to this group. | Procedure: Laparoscopy-Assisted Total Gastrectomy<br>* Laparoscopy-Assisted Total Gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative morbidity | Refers to the incidence of early postoperative complications. The early postoperative complications are defined as the events observed within postoperative 30 days. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | Quality of life scores of the patients are evaluated based on EORTC C30 questionnaire at the 3rd, 6th and 12th months after operation. | 3, 6 and 12 months | 
| Quality of life score | Quality of life scores of the patients are evaluated based on STO22 questionnaire at the 3rd, 6th and 12th months after operation. | 3, 6 and 12 months | 
| Overall incidence of postoperative morbidity | Refers to the incidence of overall postoperative complications observed during follow-up period. | 12 months |