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


Phase 1/Phase 2
20 Years
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

rate of conversion (to laparotomy or laparoscopy assisted)

Outcome Description:

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

Outcome Time Frame:

within 24 hours after operation

Safety Issue:

No

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

4-2009-0291

NCT ID:

NCT01338948

Start Date:

August 2009

Completion Date:

December 2009

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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