Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Study Overview
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Brief Summary
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Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

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.

Official Title
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Multicenter 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: Stent Dysfunction
* Procedure: Complications


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

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 randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated. | Procedure: Stent Dysfunction<br>* Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.<br>Procedure: Complications<br>* Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.<br>|
| Active Comparator: Plastic Stent<br>At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated. | Procedure: Stent Dysfunction<br>* Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.<br>Procedure: Complications<br>* Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to stent dysfunction | Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural complications | This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage. | 30 days |