NCT03599895

Brief Summary

The incidence of gastric cancer is the highest in China, and surgery is one of the most effective treatment methods. Da Vinci robot radical gastrectomy for gastric cancer has the advantage of minimally invasive and fine operation. However, due to complicated perigastric anatomy, abundant blood supply and wide distribution of lymph nodes, it is widely used in clinical use of .Combine the 3D printing technique with imaging examination (digestive endoscopy,3Dct cta/ctv, etc.) ,making the 3D model of da Vinci robot assisted radical gastrectomy can fully show the anatomical relationship around gastric cancer, determine the flow and variation of splenic portal vessels, and the distribution of splenic hilar lymph nodes. In order to eliminate the imagination difference of spatial anatomical structure before operation, it is easier for surgeons to optimize the operation plan, to control the operation process and to improve the accuracy, and to adopt individualized operation suitable for the patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

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

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

July 17, 2018

Last Update Submit

July 17, 2018

Conditions

Stomach Neoplasms

Keywords

3D printing technology

Outcome Measures

Primary Outcomes (1)

  • operation time

    record in minutes,from the beginning of anesthesia to the end

    1 hours to 6 hours through the surgery completion

Secondary Outcomes (7)

  • blood loss

    1 hours to 6 hours through the surgery completion

  • success rate

    from two days to two weeks after surgery

  • time in bed

    from two days to two weeks after surgery

  • time to take food

    from two days to two weeks after surgery

  • postoperative complication rate

    from two weeks to one year after surgery

  • +2 more secondary outcomes

Study Arms (2)

3D printing group

EXPERIMENTAL

the radical gastrectomy for gastric cancer of Davinci robotic surgery with the assistance of 3D printing model

Procedure: 3D printing model

non 3D printing group

EXPERIMENTAL

the radical gastrectomy for gastric cancer of Davinci robotic surgery without the assistance of 3D printing model

Procedure: non 3D printing model

Interventions

3D printing modelPROCEDURE

Combine the 3D printing technique with imaging examination ,making the 3D model of da Vinci robot assisted radical gastrectomy

3D printing group
non 3D printing modelPROCEDURE

da Vinci robot assisted radical gastrectomy

non 3D printing group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients without contraindications gastroscope，surgery and anesthesia;
  • There is no history of abdominal surgery, no severe abdominal cavity adhesion;
  • Not found the tumor metastasis;
  • Normal coagulation function;
  • There is no history of anticoagulant drugs, or who take aspirin, salvia miltiorrhiza, etc., should stop taking drugs for more than one week;
  • Patients and their families volunteered choice the surgical procedure and signed informed consent.

You may not qualify if:

  • Patients with preoperative assessment of distant metastasis;
  • Patients with preoperative radiation and chemotherapy or hormone therapy;
  • Patients with acute obstruction, bleeding or perforation of the emergency surgery;
  • Patients with a history of abdominal trauma or abdominal surgery;
  • Patients with contraindications gastroscope，surgery and anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

August 1, 2018

Primary Completion

December 31, 2019

Study Completion

March 30, 2020

Last Updated

July 26, 2018

Record last verified: 2018-07