Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?

Study Overview
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Brief Summary
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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.

Official Title
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Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Device: Tannenbaum 10 Fr biliary stent
* Device: Self-expandable metallic biliary stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plastic biliary stent<br>A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression | Device: Tannenbaum 10 Fr biliary stent<br>* Tannenbaum 10 Fr biliary stent<br>|
| Experimental: Self-expandable metallic biliary stent<br>A self-expandable metallic biliary stent is used to achieve biliary decompression | Device: Self-expandable metallic biliary stent<br>* ie WallFlex biliary RX<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent failure rate, and need for re-procedure before pancreaticoduodenectomy. |  | Evaluation at the day of pancreatic surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other complications related to preoperative biliary decompression, and post-surgical complications |  | Complication emerged within 120 days from pancreaticoduodenectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, Biliary decompression