NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042240001

Registered date:02/04/2024

FASTOP-GC study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedGastric cancer
Date of first enrollment10/05/2024
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)PuraStat is applied in cases of bleeding during laparoscopic or robotic gastrectomy and persists despite gauze compression.

Outcome(s)

Primary OutcomePercentage of hemostasis achieved in 3 minutes after PuraStat use
Secondary OutcomeTime 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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1)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
Exclude criteria(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

Related Information

Contact

Public contact
Name Yusuke Koseki
Address 1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail y.koseki@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Etsuro Bando
Address 1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail e.bando@scchr.jp
Affiliation Shizuoka Cancer Center