Phase II Study for Robot Assisted Distal Gastrectomy

Phase 2

• Conditions: Early Gastric Cancer
• Interventions: Device: Robot assisted distal gastrectomy (DaVinci)

• Registration Number: NCT01504997
• Lead Sponsor: Shizuoka Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-30
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Primary Completion: 2012-12
• Results First Submitted: 2016-04-18
• Results First Submitted QC: 2016-04-18
• Results First Posted: 2016-05-25
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-11-29
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot assisted distal gastrectomy	Robot assisted distal gastrectomy (DaVinci)	patients who received robot assisted distal gastrectomy

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Shizuoka Cancer Center; 🇯🇵 Shizuoka, Japan