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Phase II Study for Robot Assisted Distal Gastrectomy (RADGphaseII)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504997
First Posted: January 6, 2012
Last Update Posted: November 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Masanori Terashima, Shizuoka Cancer Center
  Purpose
The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage Ia early gastric cancer.

Condition Intervention Phase
Early Gastric Cancer Device: Robot assisted distal gastrectomy (DaVinci) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Masanori Terashima, Shizuoka Cancer Center:

Primary Outcome Measures:
  • The Incidence of Post-operative Intra-abdominal Infectious Complications [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 5 years ]
  • Relapse Free Survival [ Time Frame: 5 years ]
  • Completion Rate of Robot Assisted Surgery [ Time Frame: During the surgery, an expected average of 5 hours ]
  • Incidence of Adverse Events [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ]

Enrollment: 23
Study Start Date: December 2011
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robot assisted distal gastrectomy
patients who received robot assisted distal gastrectomy
Device: Robot assisted distal gastrectomy (DaVinci)
patients who received robot assisted distal gastrectomy
Other Name: DaVinci

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy specimen from the primary lesion shows adenocarcinoma
  2. Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography
  3. Endoscopic submucosal dissection is not indicated
  4. Tumor was located within lower two thirds of stomach
  5. Not having duodenal invasion
  6. Eastern clinical oncology group performance status is 0 or 1
  7. Body mass index is lower than 30
  8. No prior laparotomy
  9. No prior chemotherapy or radiation including those for other cancers
  10. Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl

Exclusion Criteria:

  1. Having other active cancers
  2. Possibly pregnant, or breast feeding woman
  3. with psychiatric disorder
  4. Receiving steroids
  5. With Acute myocardial infarction in 6 months or with unstable angina
  6. With uncontrolled hypertension
  7. With uncontrolled diabetes mellitus
  8. With pulmonary disease which require continuous oxygen therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504997


Locations
Japan
Shizuoka Cancer Center
Shizuoka, Japan, 411-0934
Sponsors and Collaborators
Shizuoka Cancer Center
Investigators
Principal Investigator: Masanori Terashima, M.D., Ph.D. Division of Gastric Surgery, Shizuoka Cancer Center
  More Information

Responsible Party: Masanori Terashima, Head of Gastric Surgery, Shizuoka Cancer Center
ClinicalTrials.gov Identifier: NCT01504997     History of Changes
Other Study ID Numbers: DaVinci_SCC
UMIN000006910 ( Other Identifier: UMIN )
First Submitted: December 30, 2011
First Posted: January 6, 2012
Results First Submitted: April 18, 2016
Results First Posted: May 25, 2016
Last Update Posted: November 29, 2016
Last Verified: October 2016

Keywords provided by Masanori Terashima, Shizuoka Cancer Center:
DaVinci
Robot assisted surgery
Gastrectomy
Safety
Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases