Skip to main content
Clinical Trials/NCT00500968
NCT00500968
Completed
Not Applicable

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

Karolinska Institutet1 site in 1 country50 target enrollmentNovember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreas Cancer
Sponsor
Karolinska Institutet
Enrollment
50
Locations
1
Primary Endpoint
Drain fluid content analyses
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
April 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

Drain fluid content analyses

Time Frame: At least 5 postoperative days

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

Secondary Outcomes

  • 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(At least 5 postoperative days)

Study Sites (1)

Loading locations...

Similar Trials