Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction

Study Overview
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Brief Summary
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The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.

Official Title
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Covered Versus Uncovered Metal Stents for Management of Distal Malignant Biliary Obstruction? Results of a Randomized Prospective Study.

Conditions
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Bile Duct Obstruction, Pancreatic Cancer, Gallbladder Cancer, Bile Duct Cancer

Intervention / Treatment
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* Device: Nitinella ; SX-ELLA Stent Biliary (biliary metal stent)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 years of age or older oral and written information given and informed consent obtained clinical data in accordance with malignant bile duct obstruction ultrasonography signs of extrahepatic malignant common bile duct obstruction typical radiological findings at ERCP of malignant common bile duct stenosis proximal margin of the bile duct stenosis at least 2 cm from the hepatic confluence bilirubin > 50 micromol/L radical surgery estimated not possible (temporary stenting with insertion of a plastic stent can be obtained but should be replaced by a metal stent within 4 weeks after the first ERCP procedure, and the patient is randomized at the time of insertion of the metal stent) Exclusion Criteria: patients with active hepatitis or other hepatic diseases that may cause jaundice informed consent not obtained metastasis with numerous significant intrahepatic stenosis causing blockage of one or more segments of the liver (if no segment blockage, liver metastasis is not an exclusion criteria) the patient is probably a candidate for surgical resection suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations) the proximal end of the stenosis is located within 2 cm from the hepatic confluence the patient has previously undergone BII or Roux-en-Y gastric resection, or has a significant duodenal obstruction making ERCP difficult previously (more than 4 weeks earlier) treated with a bile duct stent severe coagulation disturbance (PK-INR > 1.6)

Ages Eligible for Study
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Minimum Age: 20 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: 1<br>Covered metal stent | Device: Nitinella ; SX-ELLA Stent Biliary (biliary metal stent)<br>* Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm<br>|
| Active Comparator: 2<br>Uncovered metal stent | Device: Nitinella ; SX-ELLA Stent Biliary (biliary metal stent)<br>* Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction? |  | 12 months after stent insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bile duct, Bile duct obstruction, Biliary stent, Metal stent, ERCP, Patency, Complication, Stent occlusion