Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer, Biliary decompression
Brief summary
This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded. This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.
Interventions
DEVICETannenbaum 10 Fr biliary stent
Tannenbaum 10 Fr biliary stent
DEVICESelf-expandable metallic biliary stent
ie WallFlex biliary RX
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Resectable tumor of the head of the pancreas * Elevated serum bilirubin levels * Radiologically visible dilatation of the biliary system
Exclusion criteria
* Distant metastasis * Inoperable tumor or other reason, why the patient is unfit for surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent failure rate, and need for re-procedure before pancreaticoduodenectomy. | Evaluation at the day of pancreatic surgery |
Secondary
| Measure | Time frame |
|---|---|
| Other complications related to preoperative biliary decompression, and post-surgical complications | Complication emerged within 120 days from pancreaticoduodenectomy |
Countries
Finland
Outcome results
None listed