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

21

The median age of the 37 registered patients was 71 years (range, 27-85 years), and 25 patients (67.6%) were male. Antiplatelet or anticoagulant medication was used in 27.0% of patients. The clinical diagnoses included pancreatic cancer in 24 patients (64.9%), neuroendocrine tumor in 8 patients (22.0%), intraductal papillary mucinous neoplasm in 1 patient (2.7%), mucinous cystic neoplasm in 1 patient (2.7%), metastatic pancreatic tumor in 1 patient (2.7%), and other diagnoses in 2 patients (5.4%).

The enrollment pace was faster than initially expected. The cumulative number of cases in which PuraStat was applied was 21.

Among the 37 registered patients, no serious adverse events were observed. In the 21 patients who underwent PuraStat application, no intraoperative adverse events occurred. Postoperative adverse events within 90 days included four cases of pancreatic fistula classified as Clavien-Dindo grade IIIa (with overlap of two intra-abdominal abscesses and two organ/space surgical site infections). No adverse events of grade IIIb or higher were observed. No adverse events were considered related to PuraStat.

The primary endpoint, the proportion requiring additional hemostatic procedures, was 4 of 22 sites (18.1%). The secondary endpoints were as follows : the median time to achieve hemostasis was 22 seconds (range, 10-270 seconds); the median time required to prepare PuraStat was 114 seconds (range, 64-160 seconds); the median volume of PuraStat used was 1.0 mL (range, 0.4-2.0 mL); the incidence of intraoperative complications was 0; the incidence of postoperative rebleeding was 0; the median postoperative hospital stay was 27 days (range, 8-48 days); and within 90 days after surgery, four cases of pancreatic fistula classified as Clavien-Dindo grade IIIa were observed.

The use of PuraStat for oozing from the pancreatic transection stump following stapler closure in distal pancreatectomy demonstrated favorable hemostatic efficacy, required a short preparation time, and was suggested to be safely applicable in clinical practice.

Aug. 12, 2026

Aug. 04, 2026

https://www.clinicalkey.jp/#!/content/playContent/1-s2.0-S002248042600380X?returnurl=null&referrer=null

Yes

Individual participant data used in the analysis will be available in a pseudonymized format after publication of the primary analysis results. However, data sharing will be permitted only upon approval of the intended purpose by the investigators of this clinical study.

https://jrct.mhlw.go.jp/latest-detail/jRCTs042230143

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

Jan. 26, 2024

none