NCT01338948

Brief Summary

The purpose of this study is to assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 gastric-cancer

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
Last Updated

April 20, 2011

Status Verified

March 1, 2011

Enrollment Period

2 months

First QC Date

March 29, 2011

Last Update Submit

April 19, 2011

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • rate of conversion (to laparotomy or laparoscopy assisted)

    Visualization of upper abdominal vessels (seven vascular structures encountered during gastrectomy)

    within 24 hours after operation

Interventions

preoperative 3D-CT reconstructionPROCEDURE

Robotic Surgery with CT reconstruction images using Tile-pro program.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are older than 20 years
  • Histologically confirmed gastric adenocarcinoma
  • Patients who want robotic gastric cancer surgery
  • Preoperative clinical stage Stage I (T1N0, T1N1, T2N0) diagnosed with EGD, EUS \& CT scan
  • No history of drug allergy
  • creatinine \< 1.5 X upper normal limit
  • Informed consent

You may not qualify if:

  • Previous history of upper abdominal surgery
  • Patient refused the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (2)

  • Matsuki M, Kanazawa S, Kanamoto T, Inada Y, Kani H, Tanikake M, Yoshikawa S, Narabayashi I, Tatsumi Y, Nishimura H, Lee SW, Nomura E, Okuda J, Tanigawa N. Virtual CT gastrectomy by three-dimensional imaging using multidetector-row CT for laparoscopic gastrectomy. Abdom Imaging. 2006 May-Jun;31(3):268-76. doi: 10.1007/s00261-005-0360-2. No abstract available.

    PMID: 16705397BACKGROUND

  • Kim YM, Baek SE, Lim JS, Hyung WJ. Clinical application of image-enhanced minimally invasive robotic surgery for gastric cancer: a prospective observational study. J Gastrointest Surg. 2013 Feb;17(2):304-12. doi: 10.1007/s11605-012-2094-0. Epub 2012 Dec 1.

    PMID: 23207683DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2011

First Posted

April 20, 2011

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

April 20, 2011

Record last verified: 2011-03

Locations

KR(1)