臨床研究等提出・公開システム

Exploratory study of PuraStat (a novel self-assembling peptide) for Oozing from Stump of the Pancreas during Distal Pancreatectomy

EASY-STOP trial

Sugiura Teiichi

Shizuoka Cancer Center

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

t.sugiura@scchr.jp

Ohgi Katsuhisa

Shizuoka Cancer Center

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

+81-55-989-5222

ka.ogi@scchr.jp

Complete

Feb. 05, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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

(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

Both

Patients scheduled for distal pancreatectomy

For oozing from the pancreatic stump using stapler, apply an appropriate amount of PuraStat to the site of bleeding.

Proportion of additional hemostatic treatment

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

+81-55-989-5222

none