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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02806661
• Other study ID #: RADG160416
• Status: Not yet recruiting
• Phase: N/A
• First received: April 16, 2016
• Last updated: June 17, 2016
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: June 2016
• Source: Southwest Hospital, China
• Contact: Yingxue Hao, M.D.
• Phone: 086-2368754167
• Email: haoyingxue[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Chongqing City
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Vagus nerve-preserving Robot-assisted Gastrectomy

• Conventional Robot-assisted Gastrectomy

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Yingxue Hao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate	Recurrence rate in 3 years after operating.	up to 36 months	Yes
Secondary	3-years survival rate	Survival rate in 3 years after operating.	up to 36 months	Yes
Secondary	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	Yes
Secondary	Number of retrieving lymph nodes	The number of dissecting lymph nodes during operating.	up to 1 week	Yes
Secondary	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	Yes