Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to
varying degrees between 13-64%, depending upon which definition one uses. The "downstream"
control of the pancreatic duct with the help of a transpapillary stent might minimize the
risk for leakage over the transected pancreas surface.
Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was
continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily
measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative
days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the
patient has the external drain.
B. Co-variables measured in the form of: operation time, complications in relation to
diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in
order to evaluate the natural course of the pancreas stent.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Drain fluid content analyses
Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.
At least 5 postoperative days
Yes
Urban Arnelo
Study Director
Karolinksa university hospital
Sweden: Regional Ethical Review Board
2006/3:3
NCT00500968
November 2006
April 2011
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