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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: October 12, 2016
Last verified: October 2016
Results First Received: April 18, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Early Gastric Cancer
Intervention: Device: Robot assisted distal gastrectomy (DaVinci)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 23 patients were recruited for the study, and the initial 5 cases were excluded from the primary analysis because some of the initial RAGs were performed by invited surgeons who had lots of experience. This exclusion was prespecified in the protocol. Therefore, only the remaining 18 patients were included in the analysis.

Reporting Groups
  Description
Robot Assisted Distal Gastrectomy

patients who received robot assisted distal gastrectomy

Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy


Participant Flow:   Overall Study
    Robot Assisted Distal Gastrectomy
STARTED   18 
COMPLETED   18 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Robot Assisted Distal Gastrectomy

patients who received robot assisted distal gastrectomy

Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy


Baseline Measures
   Robot Assisted Distal Gastrectomy 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   8 
>=65 years   10 
Age 
[Units: Years]
Median (Full Range)
 65.5 
 (53 to 80) 
Gender 
[Units: Participants]
 
Female   11 
Male   7 
Region of Enrollment 
[Units: Participants]
 
Japan   18 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Overall Survival   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Relapse Free Survival   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Completion Rate of Robot Assisted Surgery   [ Time Frame: During the surgery, an expected average of 5 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Incidence of Adverse Events   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Doctor Masanori Tokunaga
Organization: Shizuoka Cancer Center
phone: 81-55098908777
e-mail: m.tokunaga@scchr.jp



Responsible Party: Masanori Terashima, Shizuoka Cancer Center
ClinicalTrials.gov Identifier: NCT01504997     History of Changes
Other Study ID Numbers: DaVinci_SCC
UMIN000006910 ( Other Identifier: UMIN )
Study First Received: December 30, 2011
Results First Received: April 18, 2016
Last Updated: October 12, 2016
Health Authority: Japan: Institutional Review Board