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A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer

Phase 2
20 Years
80 Years
Open (Enrolling)
Early Gastric Cancer

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Trial Information

A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The incidence of post-operative intra-abdominal infectious complications

Outcome Time Frame:

Participants will be followed for the duratin of hospital stay, an expected average of 10 days

Safety Issue:


Principal Investigator

Masanori Terashima, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Gastric Surgery, Shizuoka Cancer Center


Japan: Institutional Review Board

Study ID:




Start Date:

December 2011

Completion Date:

December 2017

Related Keywords:

  • Early Gastric Cancer
  • DaVinci
  • Robot assisted surgery
  • Gastrectomy
  • Safety
  • Gastric Cancer
  • Stomach Neoplasms