Comparison of Vagus Nerve-preserving RADG and Conventional RADG for AGC

Study Overview
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Brief Summary
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Through comparative observation of robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve) operative and postoperative indicators, and evaluating the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.

Detailed Description
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Compare the robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve). Observe the operative and postoperative indicators, and evaluate the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.

Official Title
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Comparison of Vagus Nerve-preserving Robot-assisted Distal Gastrectomy (RADG) and Conventional Robot-assisted Distal Gastrectomy for Advanced Gastric Cancer (AGC)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Vagus nerve-preserving Robot-assisted Gastrectomy
* Procedure: Conventional Robot-assisted Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged less than 70 years and more than 18 years; Underwent gastroscopy and biopsy - preoperative definite for advanced gastric cancer invasion depth is T2, T3; The lesion is in the middle and lower stomach; Magix routine upper gastrointestinal barium meal, endoscopic ultrasonography, abdominal CT and chest X ray examination, clearly no nerve invasion and adjacent organ invasion and distant metastasis; The preoperative examination of lung, liver, heart, renal insufficiency, surgical contraindication; The preoperative abdominal CT or abdominal ultrasound without biliary disease and gallbladder stones; No history of gastrointestinal dysfunction and other malignant tumor history; The patients voluntarily participate in the study and signed informed consent. Exclusion Criteria: Older than 70 years old or because of chemotherapy surgery and complications after intolerance; The vagus nerve invasion or invasion of adjacent organs or confirmed the presence of distant metastasis; Have a history of abdominal surgery or chemotherapy before surgery; The recent cardiovascular hemorrhagic or ischemic disease; The amount of abnormal glucose tolerance or diabetes; Not suitable for robotic surgery, such as body short that mechanical arm can not have enough activity range; The history of biliary calculi or gastrointestinal dysfunction; The other is not suitable for receiving robot surgery; Participated in other clinical studies in the last month; Other researchers not suitable for participation in the study of (HIV infection and intravenous drug addict), or other effects of this clinical study results analysis of the situation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VPRDG for AGC<br>Vagus nerve-preserving Robot-assisted distal subtotal gastrectomy (VPRDG) with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group. | Procedure: Vagus nerve-preserving Robot-assisted Gastrectomy<br> <br> |
| Active Comparator: CRDG FOR AGC<br>Conventional Robot-assisted distal subtotal gastrectomy (CRDG) with D2 lymphadenectomy without preserving vagus nerve will be performed for the treatment of patients assigned to this group. | Procedure: Conventional Robot-assisted Gastrectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | Recurrence rate in 3 years after operating. | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-years survival rate | Survival rate in 3 years after operating. | up to 36 months | 
| The rate of Calculus of gallbladder | The rate of gallbladder calculus in 1 year after operating, which is diagnosed by ultrasound. | up to 12 months | 
| Number of retrieving lymph nodes | The number of dissecting lymph nodes during operating. | up to 1 week | 
| Inflammatory factors | Detecting Interleukin -10 (IL-10), C-reactive protein (CRP) and Tumor Necrosis Factor (TNF-a) in 6 h, 12 h, 24 h, and 72h after operating. | 6 h, 12 h, 24 h, and 72h after operating | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic surgery, Vagus nerve preserving