NCT02806661

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

1.4 years

First QC Date

April 16, 2016

Last Update Submit

June 17, 2016

Conditions

Gastric Cancer

Keywords

Robotic surgeryVagus nerve preserving

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

    Recurrence rate in 3 years after operating.

    up to 36 months

Secondary Outcomes (4)

  • 3-years survival rate

    up to 36 months

  • The rate of Calculus of gallbladder

    up to 12 months

  • Number of retrieving lymph nodes

    up to 1 week

  • Inflammatory factors

    6 h, 12 h, 24 h, and 72h after operating

Study Arms (2)

VPRDG for AGC

EXPERIMENTAL

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

CRDG FOR AGC

ACTIVE COMPARATOR

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

Interventions

Vagus nerve-preserving Robot-assisted GastrectomyPROCEDURE
VPRDG for AGC
Conventional Robot-assisted GastrectomyPROCEDURE
CRDG FOR AGC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yingxue Hao, M.D.

    Southwest Hospital, Third Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingxue Hao, M.D.

CONTACT

086-2368754167haoyingxue@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2016

First Posted

June 20, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

July 1, 2018

Last Updated

June 20, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Yes, the investigators can share the data with other.

Locations

CN(1)