Overview

This trial is active, not recruiting.

Condition early gastric cancer
Treatment robot assisted distal gastrectomy (davinci)
Phase phase 2
Sponsor Shizuoka Cancer Center
Start date December 2011
End date December 2012
Trial size 23 participants
Trial identifier NCT01504997, DaVinci_SCC, UMIN000006910

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
patients who received robot assisted distal gastrectomy
robot assisted distal gastrectomy (davinci) DaVinci
patients who received robot assisted distal gastrectomy

Primary Outcomes

Measure
The incidence of post-operative intra-abdominal infectious complications
time frame: Participants will be followed for the duratin of hospital stay, an expected average of 10 days

Secondary Outcomes

Measure
Overall survival
time frame: 5 years
Relapse free survival
time frame: 5 years
Completion rate of robot assisted surgery
time frame: During the surgery, an expected average of 5 hours
Incidence of adverse events
time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer
Principal investigator Masanori Terashima, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Shizuoka Cancer Center.