Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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UNKNOWN
PHASE2
23 participants
INTERVENTIONAL
2011-12-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Robot assisted distal gastrectomy
patients who received robot assisted distal gastrectomy
Robot assisted distal gastrectomy (DaVinci)
patients who received robot assisted distal gastrectomy
Interventions
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Robot assisted distal gastrectomy (DaVinci)
patients who received robot assisted distal gastrectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
80 Years
ALL
No
Sponsors
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Shizuoka Cancer Center
OTHER
Responsible Party
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Masanori Terashima
Head of Gastric Surgery
Principal Investigators
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Masanori Terashima, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Division of Gastric Surgery, Shizuoka Cancer Center
Locations
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Shizuoka Cancer Center
Shizuoka, , Japan
Countries
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Other Identifiers
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UMIN000006910
Identifier Type: OTHER
Identifier Source: secondary_id
DaVinci_SCC
Identifier Type: -
Identifier Source: org_study_id