Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy

Wakayama Medical University

Status: Unknown

Conditions: Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy

Treatments: Procedure: pancreaticoduodenectomy

Study type: Observational

Funder types: Other

Identifiers

NCT02322424

Japan-Taiwan PD Project

Details and patient eligibility

About

Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic Fistula (ISGPF) is associated with a life-threatening complication after pancreaticoduodenectomy(PD). Therefore, The aim of this study is to clarify the risk factors for grade C PF by Japan and Taiwan cooperative project.

Full description

Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic Fistula (ISGPF) is associated with a life-threatening complication after pancreaticoduodenectomy(PD). The rate of grade C PF has been reported 2.5-6%, however, it is critical complication after PD. A large number of enrolled patients will be needed to clarify the risk factors for grade C PF. Therefore, this study design is prospective large observational study at multi-center in Japan and Taiwan.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Disease of pancreatic head or periampullary lesions to require pancreaticoduodenectomy
2. Age: 20 years or older
3. PS (ECOG performance status scale) 0-1 at the time of enrollment
4. Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

1. patients with severe respiratory disorder required oxygen inhalation
2. patients with severe liver dysfunction
3. patients with chronic renal failure with dialysis
4. patients who are unfit for this study as determined by the attending physician

Trial design

3,000 participants in 1 patient group

Patients who undergo pancreaticoduodenectomy

Treatment:

Procedure: pancreaticoduodenectomy