Gastric Cancer
Conditions
Keywords
Robotic surgery, Vagus nerve preserving
Brief summary
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
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.
Interventions
PROCEDUREVagus nerve-preserving Robot-assisted Gastrectomy
PROCEDUREConventional Robot-assisted Gastrectomy
Sponsors
Yingxue Hao
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged less than 70 years and more than 18 years; 2. Underwent gastroscopy and biopsy - preoperative definite for advanced gastric cancer invasion depth is T2, T3; 3. The lesion is in the middle and lower stomach; 4. 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; 5. The preoperative examination of lung, liver, heart, renal insufficiency, surgical contraindication; 6. The preoperative abdominal CT or abdominal ultrasound without biliary disease and gallbladder stones; 7. No history of gastrointestinal dysfunction and other malignant tumor history; 8. The patients voluntarily participate in the study and signed informed consent.
Exclusion criteria
1. Older than 70 years old or because of chemotherapy surgery and complications after intolerance; 2. The vagus nerve invasion or invasion of adjacent organs or confirmed the presence of distant metastasis; 3. Have a history of abdominal surgery or chemotherapy before surgery; 4. The recent cardiovascular hemorrhagic or ischemic disease; 5. The amount of abnormal glucose tolerance or diabetes; 6. Not suitable for robotic surgery, such as body short that mechanical arm can not have enough activity range; 7. The history of biliary calculi or gastrointestinal dysfunction; 8. The other is not suitable for receiving robot surgery; 9. Participated in other clinical studies in the last month; 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | up to 36 months | Recurrence rate in 3 years after operating. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-years survival rate | up to 36 months | Survival rate in 3 years after operating. |
| The rate of Calculus of gallbladder | up to 12 months | The rate of gallbladder calculus in 1 year after operating, which is diagnosed by ultrasound. |
| Number of retrieving lymph nodes | up to 1 week | The number of dissecting lymph nodes during operating. |
| Inflammatory factors | 6 h, 12 h, 24 h, and 72h after operating | 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. |
Countries
China
Contacts
Primary ContactYingxue Hao, M.D.
Outcome results
None listed