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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338948
• Other study ID #: 4-2009-0291
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 29, 2011
• Last updated: April 19, 2011
• Start date: August 2009
• Est. completion date: December 2009

Study information

• Verified date: March 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• preoperative 3D-CT reconstruction
Robotic Surgery with CT reconstruction images using Tile-pro program.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of conversion (to laparotomy or laparoscopy assisted)	Visualization of upper abdominal vessels (seven vascular structures encountered during gastrectomy)	within 24 hours after operation	No