A Phase 2 interventional study of Robot assisted distal gastrectomy (DaVinci) in Early Gastric Cancer, sponsored by Shizuoka Cancer Center. Status unknown at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-29.
Sponsored by Shizuoka Cancer Center · Phase 2, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 23 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Shizuoka Cancer Center is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients who received robot assisted distal gastrectomy
Device: Robot assisted distal gastrectomy (DaVinci)
patients who received robot assisted distal gastrectomy
Also known as: DaVinci
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
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
| Milestone | Robot Assisted Distal Gastrectomy |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
| participants | Robot Assisted Distal Gastrectomy |
|---|---|
| The Incidence of Post-operative Intra-abdominal Infectious Complications | 0 (0 to 12) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Robot Assisted Distal Gastrectomy | — | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Robot Assisted Distal Gastrectomy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 10 |
| Age, Continuous(years) | Robot Assisted Distal Gastrectomy |
|---|---|
| Median | 65.5 (53 to 80) |
| Sex: Female, Male(Participants) | Robot Assisted Distal Gastrectomy |
|---|---|
| Female | 11 |
| Male | 7 |
| Region of Enrollment(participants) | Robot Assisted Distal Gastrectomy |
|---|---|
| Japan | 18 |
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Shizuoka Cancer Center