Gastric Cancer
Conditions
Interventions
None listed
Sponsors
Aichi Cancer Center Hospital, Department of Gastrointestinal Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with gastric cancer planned to undergo open or laparoscopic (distal or total) gastrectomy with Roux-en-Y reconstruction using a surgical stapling device 2)Patients aged 20 years or older 3)Patients with no history of upper abdominal surgery (with the exception of laparoscopic cholecystectomy) 4)Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 5)Patients with adequate functions of major organs 6)Patients who have provided written informed consent in person for participation in the study
Exclusion criteria
Exclusion criteria: 1)Women who are pregnant or possibly pregnant, or breastfeeding 2)Patients receiving continuous systemic (oral or intravenous) steroid therapy 3)Patients with concurrent diabetes mellitus with poor control (HbA1c > 8.0%) 4)Patients with a history of allergy to nickel or chrome (a contraindication in IFU) 5)Patients with concurrent mental disorder or psychiatric symptoms judged to preclude participation in this study 6)Other patients judged by the investigator to be inappropriate as a subject of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative duodenal stump leakage | — |
Secondary
| Measure | Time frame |
|---|---|
| Staple line hemostasis, any staple malformation, incidence of serosal injury, any additional suturing, amount of blood loss, duration of surgery, incidence of intraoperative and postoperative adverse events, duration of drain placement, duration of hospital stay | — |
Countries
Japan
Contacts
Public ContactKazunari Misawa
Aichi Cancer Center Hospital Department of Gastrointestinal Surgery
Outcome results
None listed