Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study
N/A
20 Years
85 Years
20 Years
85 Years
Open (Enrolling)
Both
Pancreatic Fistula
Both
Pancreatic Fistula
Trial Information
Comparison of Feasibility Between Internal and External Pancreatic Drainage in Pancreaticoduodenectomy: Prospective Randomized Study
Inclusion Criteria:
- patient who have malignant or benign disease which needs pancreatoduodenectomy
- patient age: ≥20 and ≤85
Exclusion Criteria:
- patient who had chemotherapy or radiotherapy previous to operation.
- patient who had severe comorbid disease(cardiac, pulmonary, cerebrovascular)
- patient who had past medical history of chronic pancreatitis.
- pancreatic stent size <1mm or >5mm
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
evidence of pancreatic fistula confirmed by serum and drain amylase
Outcome Time Frame:
within the first 7 days after surgery
Safety Issue:
Yes
Principal Investigator
Sun-Whe Kim, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Seoul National University Hospital
Authority:
Korea: Institutional Review Board
Study ID:
H-0908-040-290
NCT ID:
NCT01023594
Start Date:
January 2010
Completion Date:
June 2014
Related Keywords:
- Pancreatic Fistula
- Pancreatic fistula
- Pancreatic leakage
- Pancreatoduodenectomy
- Pancreatic stent
- Fistula
- Pancreatic Fistula
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