Early Gastric Cancer
Conditions
Keywords
DaVinci, Robot assisted surgery, Gastrectomy, Safety, Gastric Cancer
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.
Interventions
DEVICERobot assisted distal gastrectomy (DaVinci)
patients who received robot assisted distal gastrectomy
Sponsors
Shizuoka Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Japan
Participant flow
Pre-assignment details
A total of 23 patients were recruited for the study, and the initial 5 cases were excluded from the primary analysis because some of the initial RAGs were performed by invited surgeons who had lots of experience. This exclusion was prespecified in the protocol. Therefore, only the remaining 18 patients were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Robot Assisted Distal Gastrectomy patients who received robot assisted distal gastrectomy
Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Robot Assisted Distal Gastrectomy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 65.5 years |
| Region of Enrollment Japan | 18 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
The Incidence of Post-operative Intra-abdominal Infectious Complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Robot Assisted Distal Gastrectomy | The Incidence of Post-operative Intra-abdominal Infectious Complications | 0 participants |
Secondary
Completion Rate of Robot Assisted Surgery
Time frame: During the surgery, an expected average of 5 hours
Secondary
Incidence of Adverse Events
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary
Overall Survival
Time frame: 5 years
Secondary
Relapse Free Survival
Time frame: 5 years