Unique ID issued by UMIN | UMIN000006910 |
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Receipt number | R000008156 |
Scientific Title | A phase II study of robot assisted distal gastrectomy with nodal dissection for clinical stage IA gastric cancer |
Date of disclosure of the study information | 2011/12/20 |
Last modified on | 2014/07/22 13:41:54 |
A phase II study of robot assisted distal gastrectomy with nodal dissection for clinical stage IA gastric cancer
RADG phase II
A phase II study of robot assisted distal gastrectomy with nodal dissection for clinical stage IA gastric cancer
RADG phase II
Japan |
Patients with Stage IA early gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To clarify safety of robot assisted distal gastrectomy with lymph node dissection
Safety
Confirmatory
Explanatory
Phase II
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 | <= |
80 | years-old | >= |
Male and Female
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) Eeatern clinical oncology group performans status is 0 or 1
7) Body mass index is lower than 30
8) No previous laparotomy
9) No previous 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
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 and require continuous oxygen therapy
23
1st name | |
Middle name | |
Last name | Terashima Masanori |
Shizuoka Cancer Center
Division of Gastric Surgery
1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
1st name | |
Middle name | |
Last name | Tokunaga Masanori |
Sizuoka Cancer Center
Division of Gastric Surgery
m.tokunaga@scchr.jp
Shizuoka Cancer Center
Shizuoka Cancer Center
Self funding
YES
NCT 1504997
clinical trials.gov
静岡がんセンター(静岡県)
2011 | Year | 12 | Month | 20 | Day |
Unpublished
Main results already published
2011 | Year | 11 | Month | 25 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 19 | Day |
2014 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008156
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