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Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

20 Years
Not Enrolling
Pancreas Cancer, Fistula

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Trial Information

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.

Inclusion Criteria:

- Inclusion Criteria include all patients planned to undergo resection of the
pancreatic body-tail are invited to participate.

Exclusion Criteria:

- The Patients who, at the time of exploration, judged to have a tumour, which is

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Drain fluid content analyses

Outcome Description:

Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.

Outcome Time Frame:

At least 5 postoperative days

Safety Issue:


Principal Investigator

Urban Arnelo

Investigator Role:

Study Director

Investigator Affiliation:

Karolinksa university hospital


Sweden: Regional Ethical Review Board

Study ID:




Start Date:

November 2006

Completion Date:

April 2011

Related Keywords:

  • Pancreas Cancer
  • Fistula
  • Pancreas
  • Leakage
  • Fistula
  • tail
  • Fistula
  • Pancreatic Neoplasms