Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression

Study Overview
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Brief Summary
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Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

Detailed Description
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Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer as there will be better drainage of the obstructed biliary system with fewer adverse events.

Official Title
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A Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer

Conditions
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Obstructive Jaundice, Pancreatic Cancer

Intervention / Treatment
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* Procedure: Metal stent
* Procedure: Plastic stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pancreatic cancer and mass in the head of pancreas causing jaundice. Patients 19 yrs of age and older Serum bilirubin > 2mg/dl CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin). Exclusion Criteria: Karnofsky score < 60 Prior (ERCP or PTC) attempts at biliary decompression for the same indication Tumor-related gastric outlet obstruction (vomiting and oral intake of < 1L/day) Ongoing or planned neoadjuvant therapy Cholangitis at presentation or coagulopathy needing reversal medication Post-surgical anatomy Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 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 |
| --- | --- |
| Active Comparator: Metal stent<br>Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent. | Procedure: Metal stent<br>* Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.<br>|
| Active Comparator: Plastic Stent<br>Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent | Procedure: Plastic stent<br>* Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to stent dysfunction | Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural complications | Complications related to the procedure which includes pancreatitis, perforation or hemorrhage. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, obstructive jaundice, Obstructive jaundice secondary to pancreatic cancer