Randomized controlled study of early replacement with factor XIII for fistula after pancreatic surgery (FIPS)

Randomized controlled study of early replacement with factor XIII for fistula after pancreatic surgery (FIPS) - RCT of early replacement with factor XIII for pancreatic fistula

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019480

Enrollment

Registered

2015-10-25

Start date

2015-10-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fistula after pancreatic surgery

Interventions

Early replacement with coagulation factor XIII Replacement with coagulation factor XIII over 2 weeks after recovery of inflammation and alimentation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patient with drain over 7 days for pancreatic fistula after pancreaticoduodenectomy or distal pancreatectomy 2) Coagulation factor XIII is 70% or less after postoperative day 7 3) CRP < 2mg/dl 4) Over 20 years old 5) Patients with written informed consent

Exclusion criteria

Exclusion criteria: 1) Alb < 2.5g/dl 2) With other inflammation 3) Thrombotic disease 4) Hemolytic anemia or blood loss anemia 5) Compromised immune system or immunosuppressed 6) Patients who are judged inappropriate for the entry into the study by the investigator

Design outcomes

Primary

Measure	Time frame
The length of pancreatic fistula cure after the recovery of inflammation and alimination	—

Countries

Japan

Contacts

Public ContactYoshinori Takeda

Cancer Institute Hospital Department of Gastroenterological Surgery

yoshinori.takeda@jfcr.or.jp03-3520-0111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026