Clinical trial NCT02322424: Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy
Official title: Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy: Prospective Large Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3,000 patients who undergo pancreaticoduodenectomy (PD) in Japan and Taiwan

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of pancreatic fistula grade C
timeFrame: 90 days after pancreaticoduodenectomy
Secondary outcomes:
measure: Incidence of overall pancreatic fistula (grade A, grade B and grade C)
timeFrame: 90 days after pancreaticoduodenectomy
measure: Incidence of clinical relevant pancreatic fistula (grade B and grade C)
timeFrame: 90 days after pancreaticoduodenectomy
measure: Incidence of postpancreatecomy hemorrhage(PPH)
timeFrame: 90 days after pancreaticoduodenectomy
measure: Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and grade B
timeFrame: 90 days after pancreaticoduodenectomy
measure: Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A
timeFrame: 90 days after pancreaticoduodenectomy
measure: Morbidity
timeFrame: 90 days after pancreaticoduodenectomy
measure: 30-day mortality
timeFrame: 30 days after pancreaticoduodenectomy
measure: 90-day mortality
timeFrame: 90 days after pancreaticoduodenectomy
Other outcomes:
Locations:
city: Linkou
country: Taiwan
facility: Chang Gun Memorial Hospital
Study officials:
affiliation: Wakayama Medical University
name: Hiroki Yamaue, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References: