FASTOP-GC study

JRCT ID: jRCTs042240001

Registered date:02/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 10/05/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): PuraStat is applied in cases of bleeding during laparoscopic or robotic gastrectomy and persists despite gauze compression.

Outcome(s)

• Primary Outcome: Percentage of hemostasis achieved in 3 minutes after PuraStat use

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

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

• Primary Sponsor: Bando Etsuro