Pancreatic Fistula
Conditions
Keywords
Pancreatic fistula, Pancreatic leakage, Pancreatoduodenectomy, Pancreatic stent
Brief summary
Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. There are two distinct methods of pancreatic stent insertion: internal stent and external stent. There was few studies comparing these methods in preventing pancreatic fistula. Furthermore, its long-term effect was not known enough. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.
Interventions
PROCEDUREPancreatic stent
Feeding tube insert at pancreatojejunostomy site as a stent. And then 1) tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall(external stent)or 2) tube is cut short (5cm length) and left in situ with fixating suture. In external stent group, tube will be removed about 1 months after operation.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| evidence of pancreatic fistula confirmed by serum and drain amylase | within the first 7 days after surgery |
Secondary
| Measure | Time frame |
|---|---|
| pancreatic endocrine and exocrine function by blood test, stool exam (steatorrhea) and computed tomography (CT) volumetry | within the first 1 year after surgery |
Countries
South Korea
Outcome results
None listed