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

June 17, 2016 updated by: Yingxue Hao

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Southwest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VPRDG for AGC
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
Active Comparator: CRDG FOR AGC
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-years survival rate
Time Frame: up to 36 months
Survival rate in 3 years after operating.
up to 36 months
The rate of Calculus of gallbladder
Time Frame: up to 12 months
The rate of gallbladder calculus in 1 year after operating, which is diagnosed by ultrasound.
up to 12 months
Number of retrieving lymph nodes
Time Frame: up to 1 week
The number of dissecting lymph nodes during operating.
up to 1 week
Inflammatory factors
Time Frame: 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.
6 h, 12 h, 24 h, and 72h after operating

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yingxue Hao

Investigators

  • Principal Investigator: Yingxue Hao, M.D., Southwest Hospital, Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

April 16, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADG160416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes, the investigators can share the data with other.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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