Status:
UNKNOWN
Phase II Study for Robot Assisted Distal Gastrectomy
Lead Sponsor:
Shizuoka Cancer Center
Conditions:
Early Gastric Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Biopsy specimen from the primary lesion shows adenocarcinoma
- Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography
- Endoscopic submucosal dissection is not indicated
- Tumor was located within lower two thirds of stomach
- Not having duodenal invasion
- Eastern clinical oncology group performance status is 0 or 1
- Body mass index is lower than 30
- No prior laparotomy
- No prior chemotherapy or radiation including those for other cancers
- 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
- Having other active cancers
- Possibly pregnant, or breast feeding woman
- with psychiatric disorder
- Receiving steroids
- With Acute myocardial infarction in 6 months or with unstable angina
- With uncontrolled hypertension
- With uncontrolled diabetes mellitus
- With pulmonary disease which require continuous oxygen therapy
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01504997
Start Date
December 1 2011
End Date
December 1 2017
Last Update
November 29 2016
Active Locations (1)
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1
Shizuoka Cancer Center
Shizuoka, Japan, 411-0934