Pancreas Cancer Clinical Trial
Official title:
Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
Verified date | September 2007 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinksa university hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Secondary | 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 | Yes |
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