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

Yingxue Hao

Status: Unknown

Conditions: Gastric Cancer

Treatments: Procedure: Vagus nerve-preserving Robot-assisted Gastrectomy; Procedure: Conventional Robot-assisted Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02806661

RADG160416

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

VPRDG for AGC

Experimental group

Description:

Vagus nerve-preserving Robot-assisted distal subtotal gastrectomy (VPRDG) with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Treatment:

Procedure: Vagus nerve-preserving Robot-assisted Gastrectomy

CRDG FOR AGC

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Robot-assisted Gastrectomy