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

未提供0 个研究点目标入组 20 人开始时间: 2024年2月26日最近更新: 2024年11月7日

试验速览

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•(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

Proportion of additional hemostatic treatment

未报告次要终点

发起方

未提供