Unique ID issued by UMIN | UMIN000050015 |
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Receipt number | R000056977 |
Scientific Title | Prospective study of laparoscopic / robot-assisted proximal gastrectomy with D2 dissection for advanced upper-third gastric cancer |
Date of disclosure of the study information | 2023/02/01 |
Last modified on | 2023/01/11 22:49:35 |
Prospective study of laparoscopic / robot-assisted proximal gastrectomy with D2 dissection for advanced upper-third gastric cancer
Prospective study of laparoscopic / robot-assisted proximal gastrectomy with D2 dissection for advanced upper-third gastric cancer
Prospective study of laparoscopic / robot-assisted proximal gastrectomy with D2 dissection for advanced upper-third gastric cancer
Prospective study of laparoscopic / robot-assisted proximal gastrectomy with D2 dissection for advanced upper-third gastric cancer
Japan |
Gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of laparoscopic / robot-assisted proximal gastrectomy with D2 dissection for advanced upper-third gastric cancer
Safety,Efficacy
3-year relapse-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
laparoscopic / robot-assisted proximal gastrectomy with D2 dissection
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically proven gastric adenocarcinoma without neoadjuvant chemotherapy.
2) A tumor mainly located in upper-third of stomach with diameter of 5cm or less. Absence of tumor invasion to esophagus or greater curvature line.
3) Clinical stage T2-3, N0-1. In case of N1, metastatic nodes can be resected by proximal gastrectomy (D2 dissection).
4) Aged 20 years or older.
5) PS (ECOG) of 0,1, and 2.
6) Body mass index less than 30.
7) Sufficient organ functions.
WBC >= 3,000/mm3, <12,000/mm3
Platelet >= 100,000/mm3
Hemoglobin >= 8 g/dL
AST =< 100 IU/L
ALT =< 100 IU/L
T.Bil =< 2.0 mg/dL
Creatinine =< 1.5 mg/dL
8) No history of gastrectomy, pancreatectomy, or splenectomy.
9) No prior treatment of radiation therapy on upper abdomen. History of chemotherapy, hormone therapy, or molecular targeted therapy is eligible.
10) Written informed consent.
1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Infectious disease with systemic therapy indicated.
3) Pregnancy, possible pregnancy, or breast-feeding.
4) Severe psychiatric disease.
5) Continuous systemic steroid or immune-suppressive drug therapy.
6) Unstable angina pectoris, or history of myocardial infarction within six months.
7) Poorly controlled hypertension.
8) Poorly controlled diabetes mellitus in spite of continuous use of insulin.
9) Severe respiratory disease requiring continuous oxygen therapy.
10) Severe renal dysfunction requiring dialysis.
100
1st name | Yukinori |
Middle name | |
Last name | Kurokawa |
Graduate School of Medicine, Osaka University
Department of Gastroenterological Surgery
565-0871
2-2 Yamadaoka, Suita City, Osaka
0668793251
ykurokawa@gesurg.med.osaka-u.ac.jp
1st name | Takuya |
Middle name | |
Last name | Hamakawa |
National Hospital Organization Osaka National Hospital
Department of Surgery
540-0006
2-1-14 Hoenzaka, Chuo-ku, Osaka City
0669421331
hamakawa.takuya.cp@mail.hosp.go.jp
Clinical Study Group of Osaka University
None
Self funding
Graduate School of Medicine, Osaka University
2-2 Yamadaoka, Suita City, Osaka
0668793251
kyamamoto13@gesurg.med.osaka-u.ac.jp
NO
2023 | Year | 02 | Month | 01 | Day |
Unpublished
Preinitiation
2023 | Year | 01 | Month | 11 | Day |
2023 | Year | 02 | Month | 01 | Day |
2030 | Year | 12 | Month | 31 | Day |
2023 | Year | 01 | Month | 11 | Day |
2023 | Year | 01 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056977
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