Gastric cancer
Conditions
Interventions
PuraStat is applied in cases of bleeding during laparoscopic or robotic gastrectomy and persists despite gauze compression.
Sponsors
Bando Etsuro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age at the time of consent is older than 18 years old 2)ECOG performance status (PS) is 0 or 1 3)Surgical treatment is scheduled within 2 weeks of obtaining consent 4) Planning to undergo laparoscopic or robotic gastrectomy for primary gastric cancer 5)Major organ functions are preserved 6)Written informed consent has been obtained
Exclusion criteria
Exclusion criteria: (1) Patients with remnant gastric cancer (2) Patients who have received preoperative chemotherapy (3) Patients with a history of coagulation disorder (4) Patients with psychiatric disorders that make it difficult to include in the study (5) Patients receiving continuous systemic administration of steroid drugs or immunosuppressants (6) Patients with a history of hypersensitivity to peptide or protein products (7) Patients with a history of severe hypersensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of hemostasis achieved in 3 minutes after PuraStat use | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve hemostasis Number of gauze used Intraoperative bleeding volume Operative time Rate of additional intraoperative hemostatic treatments required Time required to prepare PuraStat Amount of PuraStat used Duration of drainage Drain discharge volume Length of postoperative hospital stay Intraoperative complications Adverse events within 30 days after surgery Adverse events within 90 days sfter surgery Rate of postoperative rebleeding | — |
Contacts
Public ContactYusuke Koseki
Shizuoka Cancer Center
Outcome results
None listed