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Completed

NCT Number: NCT01338948

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Severance Hospital

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preoperative 3D-CT reconstruction

Procedure

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

Primary outcomes

  1. rate of conversion (to laparotomy or laparoscopy assisted)

    Time frame: within 24 hours after operation

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Feasibility Study on Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 20, 2011
Registry last updated
Apr 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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