Phase II Study for Robot Assisted Distal Gastrectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Early Gastric Cancer

Intervention / Treatment
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* Device: Robot assisted distal gastrectomy (DaVinci)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot assisted distal gastrectomy<br>patients who received robot assisted distal gastrectomy | Device: Robot assisted distal gastrectomy (DaVinci)<br>* patients who received robot assisted distal gastrectomy<br>* Other names: DaVinci;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence of Post-operative Intra-abdominal Infectious Complications |  | Participants will be followed for the duration of hospital stay, an expected average of 10 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DaVinci, Robot assisted surgery, Gastrectomy, Safety, Gastric Cancer