Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

Study Overview
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Brief Summary
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This is a single center, randomized, unblinded study to compare the rate of occlusion of plastic, uncovered metal, or fully covered metal biliary stents in patient's with surgically resectable disease or those undergoing neoadjuvant chemoradiotherapy. We will also compare occlusion rates between uncovered metal and fully covered metal biliary stents in those patients determined to have surgically unresectable disease.

Detailed Description
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Malignant biliary obstruction can result from extrinsic processes, such as proximal pancreatic ductal adenocarcinoma or metastatic lesions, or from intrinsic lesions such as cholangiocarcinoma. Malignant biliary obstruction is typically treated endoscopically with placement of either plastic (polyethylene) or metal biliary stents. Metal stents have a wider diameter than plastic stents, and have been shown to have higher patency rates, but are also 15-40 times the cost of plastic stents. Metal stents with a polymer coating have been developed to prevent tumor ingrowth into the stent, which can lead to stent occlusion. Cost analysis has demonstrated an advantage to the use of metal stents in patients with unresectable disease, or who may achieve operable status following neoadjuvant chemotherapy, while either plastic stents or metal stents are used when patients are deemed to have a surgically resectable lesion. Patient's determined to have resectable, or borderline resectable malignancy (those who may achieve resectability status following neoadjuvant chemotherapy) will receive either plastic, uncovered metal, or covered metal stents in a randomized fashion, while patients determined to have surgically unresectable malignancy will randomly receive either covered or uncovered metal biliary stents. The primary aim of this study is to prospectively evaluate stent occlusion rates in patients presenting with malignant biliary obstruction. Secondary aims of the study will include a cost analysis of each stent type, rate of hospital admission following stent placement, days off of chemotherapy due to procedural complication, and rate of acute cholecystitis associated with stent placement.

Official Title
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A Prospective Randomized Trial of Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Device: Biliary stent placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female older than 18 Capable of providing written informed consent Presenting with malignant biliary obstruction requiring biliary drainage either from proximal pancreatic malignancy, metastatic disease, or intrinsic biliary malignancy. The patient must have an established diagnosis of underlying malignancy, and surgical resectability status established, prior to enrollment in this study. Exclusion Criteria Inability to undergo conscious sedation or monitored anesthesia Prior pancreatico-biliary surgery Evidence of acute cholecystitis at time of endoscopic procedure Intraluminal filling defect requiring endoscopic removal prior to stent placement Inability to provide written informed consent Malignancy not verified prior to stent placement

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: Resectable; plastic stent<br>Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. | Device: Biliary stent placement<br>* Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.<br>|
| Experimental: Resectable; uncovered metal stent<br>Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. | Device: Biliary stent placement<br>* Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.<br>|
| Experimental: Resectable; fully covered metal stent<br>Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. | Device: Biliary stent placement<br>* Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.<br>|
| Experimental: Unresectable; uncovered metal stent<br>Patients determined to have surgically non-resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. | Device: Biliary stent placement<br>* Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.<br>|
| Experimental: Unresectable; fully covered metal stent<br>Patients determined to have surgically non-resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. | Device: Biliary stent placement<br>* Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement | Time of stent occlusion, attempted surgical resection or patient death to 300 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement. |  | Costs measured up to 500 days | 
| Determine the Days of Hospitalization Following Stent Placement | Number of total days of hospitalization for all patients in each group | From stent placement up to 500 days post stent | 
| Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents | Total number of days in which neoadjuvant therapy was delayed due to stent related issues | Time from stent placement to 500 days | 
| Assess Rate of Acute Cholecystitis Associated With Each Type of Stent |  | time from stent placement to 500 days |