Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
Information source: Karolinska Institutet
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreas Cancer; Fistula
Intervention: Left sided pancreatic resection (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Karolinska Institutet Official(s) and/or principal investigator(s):
Urban Arnelo, Principal Investigator, Affiliation: Karolinksa university hospital
Overall contact:
Farshad Frozanpor, Email: farshad.frozanpor@sodersjukhuset.se
Summary
Randomized study assessing the effect of transpapillary pancreas duct stent in resection of
the pancreatic tail.
Clinical Details
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Post-operativt daily measurement of pancreatic enzyme content in the drain fluid. X-Amylase and X-Protein as long as the patient has the external drain.
Secondary outcome: Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent
Detailed description:
Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to
varying degrees between 13,2-64% [30], 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. Daily measurement of pancreatic enzyme content in the drain
fluid. 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 and cost. Patients receiving a pancreas stent are
followed in order to evaluate the natural course of the pancreas stent.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
un-resectable.
Locations and Contacts
Farshad Frozanpor, Email: farshad.frozanpor@sodersjukhuset.se
Karolinksa university hospital, Stockholm 14186, Sweden; Recruiting
Farshad Frozanpor
Urban Arnelo
Additional Information
Starting date: November 2006
Ending date: March 2009
Last updated: July 16, 2007
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