NCT02322424

Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Wakayama Medical University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy

Interventions

Type	Name	Description
PROCEDURE	pancreaticoduodenectomy

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2014-12-23
• Last updated: 2014-12-23

Locations

1 site across 1 country: Taiwan