Unique ID issued by UMIN | UMIN000010877 |
---|---|
Receipt number | R000012727 |
Scientific Title | Clinical evaluation of the safety and the usefulness of robot assisted distal gastrectomy with nodal dissection for early gastric cancer |
Date of disclosure of the study information | 2013/06/04 |
Last modified on | 2013/06/04 22:18:36 |
Clinical evaluation of the safety and the usefulness of robot assisted distal gastrectomy with nodal dissection for early gastric cancer
Clinical evaluation of the safety and the usefulness of RADG
Clinical evaluation of the safety and the usefulness of robot assisted distal gastrectomy with nodal dissection for early gastric cancer
Clinical evaluation of the safety and the usefulness of RADG
Japan |
Stage IA early gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety and the usefulness of robot assisted distal gastrectomy
Safety
Confirmatory
Not applicable
The incidence of post-operative intra-abdominal infectious complications (anastomotic leakage, pancreas related infection, and intra-abdominal abscess)
Oveall survival
Relapse free survival
Completion rate of robot assised surgery
The incidence of adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Robot assisted surgery
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically confirmed gastric cancer
2) Diagnosed as Stage IA early gastric cancer
3) Endoscopic submucosal dissection is not indicated
4) Tumor location is within the resected area by distal gastrectomy
5) No duodenal invasion
6) Over 20 years of age
7) Eeatern clinical oncology group performans status is 0 or 1
8) Body mass index is lower than 30
9) No previous upper laparotomy
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
11) Provision of written informed consent
1) Having other active cancers
2) Possibly pregnant, or breast feeding woman
3) With psychiatric disorder
4) Receiving steroids
5) With acute myocardial infaction in 6 months or with unstable ungina
6) With uncontrolled hypertention
7) With uncontrolled diabetes mellitus
8) With pulmonary disease requiring continuous oxygen therapy
10
1st name | |
Middle name | |
Last name | Masaaki Oka |
Yamaguchi University Graduate School of Medicine
Department of Digestive Surgery and Surgical Oncology
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
1st name | |
Middle name | |
Last name | Shigefumi Yoshino |
Yamaguchi University Graduate School of Medicine
Department of Digestive Surgery and Surgical Oncology
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
0836-22-2264
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Self funding
NO
2013 | Year | 06 | Month | 04 | Day |
Unpublished
Open public recruiting
2013 | Year | 05 | Month | 16 | Day |
2013 | Year | 06 | Month | 10 | Day |
2013 | Year | 06 | Month | 04 | Day |
2013 | Year | 06 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012727
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |