Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy
Conditions
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREpancreaticoduodenectomy
Sponsors
Wakayama Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of pancreatic fistula grade C | 90 days after pancreaticoduodenectomy |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of clinical relevant pancreatic fistula (grade B and grade C) | 90 days after pancreaticoduodenectomy |
| Incidence of postpancreatecomy hemorrhage(PPH) | 90 days after pancreaticoduodenectomy |
| Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and grade B | 90 days after pancreaticoduodenectomy |
| Incidence of overall pancreatic fistula (grade A, grade B and grade C) | 90 days after pancreaticoduodenectomy |
| Morbidity | 90 days after pancreaticoduodenectomy |
| 30-day mortality | 30 days after pancreaticoduodenectomy |
| 90-day mortality | 90 days after pancreaticoduodenectomy |
| Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A | 90 days after pancreaticoduodenectomy |
Countries
Taiwan
Contacts
Primary ContactHiroki Yamaue, M.D., PhD.
Backup ContactHiroki Yamaue, M.D., PhD.
Outcome results
None listed