Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction

Study Overview
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Brief Summary
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The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.

Official Title
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Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction

Conditions
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Distal Bile Duct Obstruction

Intervention / Treatment
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* Device: Covered Self-expanding metal biliary stents (C-SEMS)
* Device: Uncovered Self-expanding metal biliary stents (U-SEMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice 18 years of age or older serum bilirubin > 2mg/dL Exclusion Criteria: prior endoscopic or percutaneous biliary drainage post-surgical anatomy primary site of biliary obstruction involving the common hepatic duct or hilum tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: U-SEMS group<br>Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific). | Device: Uncovered Self-expanding metal biliary stents (U-SEMS)<br>* Used for palliation of inoperable malignant distal bile duct obstructions.<br>|
| Active Comparator: C-SEMS Group<br>Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific) | Device: Covered Self-expanding metal biliary stents (C-SEMS)<br>* Used for palliation of inoperable malignant distal bile duct obstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Long-term Stent Failure | Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Adverse Stent-related or Intervention-related Outcomes | Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation. | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, cholangiocarcinoma, metastatic malignancy, jaundice