Gastric cancer (cStage IA-IIIC)
Conditions
Interventions
Minimally invasive gastrectomy assisted by EUREKA-alpha
Sponsors
The University of Osaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed gastric cancer (2) Scheduled to undergo laparoscopic or robot assisted gastrectomy (3) No evidence of distant metastasis and diagnosed as cStage IA-IIIC according to the 15th edition of the Japanese Classification of Gastric Carcinoma (in cases with preoperative chemotherapy, staging is based on post treatment status) (4) No bulky lymph node metastasis ??ulky lymph node metastasis is defined as either, Two or more lymph nodes >=1.5 cm in the longest diameter located adjacent to each other around the celiac artery, common hepatic artery, splenic artery, or proper hepatic artery, or anterior to the superior mesenteric vein, or A conglomerate of lymph nodes (single or multiple) forming a mass >=3.0 cm in overall longest diameter. (5) Considered resectable with R0 resection (6) Macroscopic type other than type 4 (7) No invasion to adjacent organs (8) No invasion of the esophagus or duodenum (9) Not a remnant gastric cancer (10) Age >=18 years at the time of registration (11) Performance status (ECOG) of 0 or 1 (12) No history of upper abdominal surgery other than laparoscopic cholecystectomy (13) No history of abdominal radiotherapy for any malignancy. History of endoscopic treatment (EMR, ESD), chemotherapy, or endocrine therapy is allowed (14) Laboratory data within 28 days prior to registration (the same weekday within 4 weeks before registration is acceptable) meet all of the following criteria ??1,White blood cell count >=3,000/mm3 ??2,Platelet count >=100,000/mm3 ??3,Hemoglobin >=8.0 g/dL ??4,Total bilirubin <=2.0 mg/dL ??5,AST <=100 U/L ??6,ALT <=100 U/L ??7,Serum creatinine <=1.5 mg/dL (15) Written informed consent for participation in this study has been obtained from the patient
Exclusion criteria
Exclusion criteria: (1) Presence of active double or multiple cancers (including synchronous or metachronous cancers with a disease-free interval of <=5 years). ??owever, the following cancers are not regarded as active double/multiple cancers, even if the disease-free interval is less than 5 years, because their 5-year relative survival rates exceed 95%: ?? Gastric cancer (adenocarcinoma, intestinal type): Stage 0-I ?? Colon cancer (adenocarcinoma): Stage 0-I ?? Rectal cancer (adenocarcinoma): Stage 0-I ?? Esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma): Stage 0 ?? Breast cancer (non-invasive ductal or lobular carcinoma): Stage 0 ?? Breast cancer (invasive ductal or lobular carcinoma, Paget's disease): Stage 0-IIA ?? Endometrial cancer (endometrioid or mucinous adenocarcinoma): Stage I ?? Prostate cancer (adenocarcinoma): Stage I-II ?? Cervical cancer (squamous cell carcinoma): Stage 0 ?? Thyroid cancer (papillary or follicular carcinoma): Stage I-III ?? Renal cell carcinoma (clear cell or chromophobe type): Stage I ??ther carcinoma in situ-equivalent lesions. ??taging should generally follow the UICC-TNM 7th edition or the corresponding Japanese classification systems. (2) Presence of an active infection requiring systemic therapy (3) Fever >=38.0 degree at the time of registration (4) Psychiatric disease or symptoms that interfere with daily life and make study participation difficult (5) Continuous systemic administration (oral or intravenous) of corticosteroids or other immunosuppressive agents (6) Unstable angina (onset or worsening within the past 3 weeks) or history of myocardial infarction within the past 6 months (7) Uncontrolled diabetes mellitus or diabetes under continuous insulin therapy (8) Positive for HIV antibody (testing is not mandatory) (9) Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by chest CT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Incidence of intraoperative adverse events (CTCAE v5.0 Grade>=2) Phase II: Incidence of postoperative overall complications (Clavien-Dindo classification Grade>=III) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I Incidence of postoperative overall complications of Clavien Dindo classification Grade>=III Incidence of postoperative intra abdominal infectious complications of Clavien Dindo classification Grade>=III (anastomotic leakage, pancreatic fistula, intra abdominal abscess) Amylase levels in drain fluid at the upper margin of the pancreas on postoperative days 1 and 3 Operation time Blood loss Rate of conversion to open surgery Qualitative assessment by the operating surgeons regarding the workload reduction effect of EUREKAalpha Phase II Incidence of postoperative intra abdominal infectious complications of Clavien Dindo classification Grade>=III (anastomotic leakage, pancreatic fistula, intra abdominal abscess) Incidence of postoperative overall complications of Clavien-Dindo classification Grade>=II Incidence of postoperative intra abdominal infectious complications of Clavien Dindo classification Grade>=II (anastomotic leakage, pancreatic fistula, intra abdominal abscess) Incidence of intraoperative adverse events Amylase levels in drain fluid at the upper margin of the pancreas on postoperative days 1 and 3 Operation time Blood loss Rate of conversion to open surgery Qualitative assessment by the operating surgeons regarding the workload reduction effect of EUREKA alpha | — |
Countries
Japan
Contacts
Public ContactTakuro Saito
Graduate School of Medicine, The University of Osaka Department of Gastroenterological Surgery
Outcome results
None listed