Patients scheduled for distal pancreatectomy
Conditions
Interventions
For oozing from the pancreatic stump using stapler, apply an appropriate amount of PuraStat to the site of bleeding.
Sponsors
Sugiura Teiichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age 18 or older at the time consent is obtained (2) ECOG performance status (PS) is between 0 and 2 (3) Surgical treatment is scheduled within 2 weeks of obtaining consent (4) Distal pancreatectomy is planned (including open, laparoscopic, and robot-assisted procedures, with or without splenectomy) (5) Major organ functions are preserved (6) Written consent has been obtained from the patient after a full explanation of the trial prior to enrollment in the study
Exclusion criteria
Exclusion criteria: (1) Patients with localized or systemically active infections requiring treatment (2) Pregnant or lactating women, women who may be currently pregnant or who are unwilling to use contraception during the study period (3) Patients with a history of coagulopathy (Patients with coagulopathy or unable to withdraw antiplatelet or anticoagulant drugs) (4) Patients who are unable to enroll in this trial due to psychiatric disorders (5) Patients receiving systemic administration of steroid or immunosuppressive agents. (6) Patients with a history of hypersensitivity to peptide or protein products (7) Patients with a history of severe hypersensitivity (8) Patients deemed ineligible by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of additional hemostatic treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to hemostasis Time for preparation of PuraStat Total amount of PuraStat used (mL) per patient Intraoperative complications Proportion of postoperative hemorrhage Postoperative hospital stay (days) Adverse events within 90 days after surgery | — |
Contacts
Public ContactKatsuhisa Ohgi
Shizuoka Cancer Center
Outcome results
None listed