Phase II Study for Robot Assisted Distal Gastrectomy (RADGphaseII)

October 12, 2016 updated by: Masanori Terashima, Shizuoka Cancer Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Shizuoka, Japan, 411-0934
        • Shizuoka Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • DaVinci

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 5 years
5 years
Relapse Free Survival
Time Frame: 5 years
5 years
Completion Rate of Robot Assisted Surgery
Time Frame: During the surgery, an expected average of 5 hours
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
Participants will be followed for the duration of hospital stay, an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shizuoka Cancer Center

Investigators

  • Principal Investigator: Masanori Terashima, M.D., Ph.D., Division of Gastric Surgery, Shizuoka Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 30, 2011

First Submitted That Met QC Criteria

January 5, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DaVinci_SCC
  • UMIN000006910 (Other Identifier: UMIN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Gastric Cancer

Clinical Trials on Robot assisted distal gastrectomy (DaVinci)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe