臨床研究等提出・公開システム

Exploratory study of PuraStat (a novel self-assembling peptide) for hemorrhage during laparoscopic or robotic gastrectomy for Gastric cancer

FASTOP-GC study

Bando Etsuro

Shizuoka Cancer Center

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

e.bando@scchr.jp

Koseki Yusuke

Shizuoka Cancer Center

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

+81-55-989-5222

y.koseki@scchr.jp

Complete

April. 02, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

(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

Both

Gastric cancer

PuraStat is applied in cases of bleeding during laparoscopic or robotic gastrectomy and persists despite gauze compression.

Percentage of hemostasis achieved in 3 minutes after PuraStat use

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

+81-55-989-5222

No

none