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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy
  • Pancreatic Fistula

NCT number NCT02322424
Study type Observational [Patient Registry]
Source Wakayama Medical University
Contact Hiroki Yamaue, M.D., PhD.
Phone +81-73-441-0613
Email yamaue-h@wakayama-med.ac.jp
Status Recruiting
Phase N/A
Start date December 2014
Completion date June 2017