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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vagus nerve-preserving Robot-assisted Gastrectomy
Conventional Robot-assisted Gastrectomy
Sponsored by
Yingxue Hao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Robotic surgery, Vagus nerve preserving

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Southwest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VPRDG for AGC

CRDG FOR AGC

Arm 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.

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.

Outcomes

Primary Outcome Measures

Recurrence rate
Recurrence rate in 3 years after operating.

Secondary Outcome Measures

3-years survival rate
Survival rate in 3 years after operating.
The rate of Calculus of gallbladder
The rate of gallbladder calculus in 1 year after operating, which is diagnosed by ultrasound.
Number of retrieving lymph nodes
The number of dissecting lymph nodes during operating.
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.

Full Information

First Posted
April 16, 2016
Last Updated
June 17, 2016
Sponsor
Yingxue Hao
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1. Study Identification

Unique Protocol Identification Number
NCT02806661
Brief Title
Comparison of Vagus Nerve-preserving RADG and Conventional RADG for AGC
Official Title
Comparison of Vagus Nerve-preserving Robot-assisted Distal Gastrectomy (RADG) and Conventional Robot-assisted Distal Gastrectomy for Advanced Gastric Cancer (AGC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yingxue Hao

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Robotic surgery, Vagus nerve preserving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VPRDG for AGC
Arm Type
Experimental
Arm 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.
Arm Title
CRDG FOR AGC
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Vagus nerve-preserving Robot-assisted Gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Conventional Robot-assisted Gastrectomy
Primary Outcome Measure Information:
Title
Recurrence rate
Description
Recurrence rate in 3 years after operating.
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
3-years survival rate
Description
Survival rate in 3 years after operating.
Time Frame
up to 36 months
Title
The rate of Calculus of gallbladder
Description
The rate of gallbladder calculus in 1 year after operating, which is diagnosed by ultrasound.
Time Frame
up to 12 months
Title
Number of retrieving lymph nodes
Description
The number of dissecting lymph nodes during operating.
Time Frame
up to 1 week
Title
Inflammatory factors
Description
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.
Time Frame
6 h, 12 h, 24 h, and 72h after operating

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, aged less than 70 years and more than 18 years; Underwent gastroscopy and biopsy - preoperative definite for advanced gastric cancer invasion depth is T2, T3; The lesion is in the middle and lower stomach; 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; The preoperative examination of lung, liver, heart, renal insufficiency, surgical contraindication; The preoperative abdominal CT or abdominal ultrasound without biliary disease and gallbladder stones; No history of gastrointestinal dysfunction and other malignant tumor history; The patients voluntarily participate in the study and signed informed consent. Exclusion Criteria: Older than 70 years old or because of chemotherapy surgery and complications after intolerance; The vagus nerve invasion or invasion of adjacent organs or confirmed the presence of distant metastasis; Have a history of abdominal surgery or chemotherapy before surgery; The recent cardiovascular hemorrhagic or ischemic disease; The amount of abnormal glucose tolerance or diabetes; Not suitable for robotic surgery, such as body short that mechanical arm can not have enough activity range; The history of biliary calculi or gastrointestinal dysfunction; The other is not suitable for receiving robot surgery; Participated in other clinical studies in the last month; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingxue Hao, M.D.
Phone
086-2368754167
Email
haoyingxue@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingxue Hao, M.D.
Organizational Affiliation
Southwest Hospital, Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes, the investigators can share the data with other.

Learn more about this trial

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

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