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

NCT ID: NCT02806661

Last Updated: 2016-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vagus nerve-preserving Robot-assisted Gastrectomy

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Conventional Robot-assisted Gastrectomy

Intervention Type PROCEDURE

Interventions

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Vagus nerve-preserving Robot-assisted Gastrectomy

Intervention Type PROCEDURE

Conventional Robot-assisted Gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yingxue Hao

OTHER

Sponsor Role lead

Responsible Party

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Yingxue Hao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yingxue Hao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, Third Military Medical University

Locations

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Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Central Contacts

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Yingxue Hao, M.D.

Role: CONTACT

086-2368754167

Other Identifiers

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RADG160416

Identifier Type: -

Identifier Source: org_study_id

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