UnknownNot Applicable

Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy

Taiwan3,000 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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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

What they're measuring

Incidence of pancreatic fistula grade C

Timeframe: 90 days after pancreaticoduodenectomy

Trial details

NCT IDNCT02322424

SponsorWakayama Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-06

Contact for this trial

Hiroki Yamaue, M.D., PhD.

+81-73-441-0613 yamaue-h@wakayama-med.ac.jp

View on ClinicalTrials.gov More Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy trials