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

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Procedure: Conventional Robot-assisted Gastrectomy; Procedure: Vagus nerve-preserving Robot-assisted Gastrectomy

• Registration Number: NCT02806661
• Lead Sponsor: Yingxue Hao

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.

Study Timeline

• Study First Submitted: 2016-04-16
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-17
• Last Update Submitted: 2016-06-17
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-20
• Study Start: 2016-07
• Primary Completion: 2017-12
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRDG FOR AGC	Conventional Robot-assisted Gastrectomy	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.
VPRDG for AGC	Vagus nerve-preserving Robot-assisted Gastrectomy	Vagus nerve-preserving Robot-assisted distal subtotal gastrectomy (VPRDG) with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Primary Outcome Measures

Name	Time	Method
Recurrence rate	up to 36 months	Recurrence rate in 3 years after operating.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China