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Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
preoperative 3D-CT reconstruction
Sponsored by
Yonsei University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Severance Hospital

Outcomes

Primary Outcome Measures

rate of conversion (to laparotomy or laparoscopy assisted)
Visualization of upper abdominal vessels (seven vascular structures encountered during gastrectomy)

Secondary Outcome Measures

Full Information

First Posted
March 29, 2011
Last Updated
April 19, 2011
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01338948
Brief Title
Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients
Official Title
A Feasibility Study on Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Diagnosis of early stage gastric cancer -> CT scanning & EUS for staging -> (Registration) -> Robotic surgery with image reconstruction -> Conversion rate, Tumor location & vascular anatomy correlation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
preoperative 3D-CT reconstruction
Intervention Description
Robotic Surgery with CT reconstruction images using Tile-pro program.
Primary Outcome Measure Information:
Title
rate of conversion (to laparotomy or laparoscopy assisted)
Description
Visualization of upper abdominal vessels (seven vascular structures encountered during gastrectomy)
Time Frame
within 24 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Previous history of upper abdominal surgery Patient refused the study
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16705397
Citation
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.
Results Reference
background
PubMed Identifier
23207683
Citation
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.
Results Reference
derived

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Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients

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