Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy: Prospective Large Observational Study

Conditions
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Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy

Intervention / Treatment
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* Procedure: pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Disease of pancreatic head or periampullary lesions to require pancreaticoduodenectomy Age: 20 years or older PS (ECOG performance status scale) 0-1 at the time of enrollment Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: patients with severe respiratory disorder required oxygen inhalation patients with severe liver dysfunction patients with chronic renal failure with dialysis patients who are unfit for this study as determined by the attending physician

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who undergo pancreaticoduodenectomy<br> | Procedure: pancreaticoduodenectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pancreatic fistula grade C |  | 90 days after pancreaticoduodenectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of overall pancreatic fistula (grade A, grade B and grade C) |  | 90 days after pancreaticoduodenectomy | 
| 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 | 
| Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A |  | 90 days after pancreaticoduodenectomy | 
| Morbidity |  | 90 days after pancreaticoduodenectomy | 
| 30-day mortality |  | 30 days after pancreaticoduodenectomy | 
| 90-day mortality |  | 90 days after pancreaticoduodenectomy |