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Phase II Study for Robot Assisted Distal Gastrectomy (RADGphaseII)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Masanori Terashima, Shizuoka Cancer Center
ClinicalTrials.gov Identifier:
NCT01504997
First received: December 30, 2011
Last updated: January 9, 2013
Last verified: January 2013
History of Changes

December 30, 2011
January 9, 2013
December 2011
December 2012   (final data collection date for primary outcome measure)
The incidence of post-operative intra-abdominal infectious complications [ Time Frame: Participants will be followed for the duratin of hospital stay, an expected average of 10 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01504997 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Relapse free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Completion rate of robot assisted surgery [ Time Frame: During the surgery, an expected average of 5 hours ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase II Study for Robot Assisted Distal Gastrectomy
A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Early Gastric Cancer
Device: Robot assisted distal gastrectomy (DaVinci)
patients who received robot assisted distal gastrectomy
Other Name: DaVinci
Experimental: Robot assisted distal gastrectomy
patients who received robot assisted distal gastrectomy
Intervention: Device: Robot assisted distal gastrectomy (DaVinci)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
23
December 2017
December 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01504997
DaVinci_SCC, UMIN000006910
Yes
Masanori Terashima, Shizuoka Cancer Center
Shizuoka Cancer Center
Not Provided
Principal Investigator: Masanori Terashima, M.D., Ph.D. Division of Gastric Surgery, Shizuoka Cancer Center
Shizuoka Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP