Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy
1 other identifier
observational
3,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 17, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 23, 2014
December 1, 2014
2.5 years
December 17, 2014
December 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of pancreatic fistula grade C
90 days after pancreaticoduodenectomy
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
Patients who undergo pancreaticoduodenectomy
Interventions
Eligibility Criteria
3,000 patients who undergo pancreaticoduodenectomy (PD) in Japan and Taiwan
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gun Memorial Hospital
Linkou District, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hiroki Yamaue, M.D., PhD.
Wakayama Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 42 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Second Department of Surgery
Study Record Dates
First Submitted
December 17, 2014
First Posted
December 23, 2014
Study Start
December 1, 2014
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
December 23, 2014
Record last verified: 2014-12