A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Study Overview
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Brief Summary
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The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.

Official Title
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A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Conditions
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Cholestasis, Extrahepatic

Intervention / Treatment
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* Device: WallFlex™ Biliary Fully Covered Metal Stent placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Clinical symptoms of biliary obstruction Inoperable extrahepatic biliary obstruction by any malignant process Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: Participation in an Investigational Study within 90 days prior to date of patient consent Strictures that cannot be dilated enough to pass the delivery system Perforation of any duct within the biliary tree Presence of a metal biliary stent Presence of any esophageal or duodenal stent Patients for whom endoscopic procedures are contraindicated Patients with known sensitivity to any components of the stent or delivery system Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver Patients with an anticipated life expectancy of < 3 months

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WallFlex Biliary Fully Covered stent<br>Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent | Device: WallFlex™ Biliary Fully Covered Metal Stent placement<br>* Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate Clinical Palliation of the Biliary Obstruction | Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort. | At treatment | 
| Ability to Successfully Remove a Stent Upon Removal Attempt | The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties. | 6 months | 
| Re-interventions | Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent. | Until 6 months or death | 
| Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms | Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment. | 1 Month | 
| Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms | Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment. | 3 months | 
| Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms | Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment. | 6 months | 
| Bilirubin Level Reduction | Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl. | 1 month | 
| Stent Patency at 1 Month | Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms. | 1 month | 
| Stent Patency at 3 Months | Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3). | 3 Months | 
| Stent Patency at 6 Months | Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6). | 6 Months | 
| Time to Stent Occlusion | Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion. | Until 6 Months or death | 
| Number of Device-Related Adverse Events | Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant. | Until 6 months or death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant, Cholestasis, Extrahepatic, Biliary obstruction