Gastric cancer
Conditions
Interventions
Reinforcement with buried suture for duodenal stump in robotic gastrectomy (distal or total gastrectomy) with Billroth-II or Roux-en-Y reconstruction.
Using linear stapling device with bioabsorbable
Sponsors
Tohoku Medical and Pharmaceutical University
Iwate Prefectural Isawa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma by endoscopic biopsy. 2) Distal or total gastrectomy is required for radical resection, and R0 surgery is feasible. 3) Either Billroth-II or R-en-Y reconstruction is planned. 4) The diagnosis of clinical stage I, II or III. 5) No invasion to esophagus. 6) No invasion to duodenum. 7) Not a stump cancer of stomach. 8) Adequate oral intake and no need for preoperative fluids. 9) No combined resection other than the gallbladder. 10) Aged 20 years old or older. 11) Eastern Cooperative Oncology Group performance status of 0 or 1. 12) No prior abdominal radiotherapy for any malignancies. History of chemotherapy and/or endocrine therapy is eligible. 13) No history of upper abdominal surgery except laparoscopic cholecystectomy. 14) Body mass index (BMI) is less than 30. 15) Adequate organ functions defined as; i) WBC of 3,000/mm3 or more ii) Platelet count 100,000/mm3 or more iii) AST and/or ALT of 100 IU/L or less iv) T.Bil of 2.0 mg/dL or less v) Creatinine of 1.5 mg/dL or less 16) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Body temperature of 38 degrees Celsius or higher. 4) During pregnancy, within 28 days postpartum, or during lactation. 5) Severe mental disease. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy. 9) HIV antibody positive. 10) Uncontrolled diabetes mellitus. 11) Respiratory disease requiring continuous oxygen administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of duodenal stump leakage after gastrectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. operative time, 2. estimated blood loss, 3. incidence of postoperative complication, 4. hemostasis at duodenal stump, 5. injury at duodenal stump, 6. postoperative hospital stay | — |
Countries
Japan
Contacts
Public ContactMakoto Hikage
Tohoku Medical and Pharmaceutical University Division of Gastroenterologic Surgery
Outcome results
None listed