WallFlex Biliary Post Liver Transplant IDE Pilot

Study Overview
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Brief Summary
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The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.

Official Title
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A Multi-Center, Prospective Study the WallFlex Biliary RX Fully Covered Stent for the Treatment of Anastomotic Biliary Strictures in Post Liver Transplant Patients.

Conditions
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Anastomotic Biliary Stricture Post Orthotopic Liver Transplant

Intervention / Treatment
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* Device: WallFlex Biliary Fully Covered Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by: Clinical signs and symptoms including jaundice, abdominal pain, pruritis, and cholangitis Abnormal liver function tests (serum bilirubin > 1.5 and/or elevated alkaline phosphatase levels) Abnormal imaging on ultrasound, CT scan, or MRCP suggestive of a biliary stricture Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: Roux-en-Y choledochojejunostomy Suspected nonanastomotic biliary strictures based on imaging(i.e. multiple strictures, strictures that are longer than 8cm in length, strictures located in the intrahepatic ducts and/or in the donor duct proximal to the site of anastomosis) Living donor transplants Transplants performed within 30 days (fresh transplants) Perforation of any duct within the biliary tree Patients with known sensitivity to any components of the stent or delivery system Patients with malignancy involving the biliary tree (including hepatocellular carcinoma) Patients with poor Karnofsky score Life expectancy of less than one year Inability to pass a guidewire through the strictured area Previous biliary metal or multiple plastic stent placement Drug-induced or cholestatic hepatitis from an infective cause Redundant bile duct that may be treated by temporary placement of stent or conversion to a RouxEnY hepaticojejunostomy Choledocholithiasis/biliary cast syndrome

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WallFlex Biliary Fully Covered Stent<br>All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent | Device: WallFlex Biliary Fully Covered Stent<br>* Investigational device evaluated for the treatment for benign biliary strictures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stricture Resolution at the Time of Stent Removal. | Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early. | At 3 months (per protocol removal) or at early removal. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety is being measured by the occurrence, severity, device- and procedure-relatedness of adverse events during stent placement, during stent indwell, at the time of stent removal, and after stent removal. Unit of measure will be the actual number of adverse events that occurred. | From enrollment through end of study. | 
| Stent Removability | Stent removability is measured as the ability to successfully remove the stent at initial placement in case of inadequate stent placement, during the stent indwell period in case of stent failure, or at the end of indwell without any clinically significant complications or technical difficulties. A clinically significant complication is defined as a medical event that requires an intervention. | At 3 months (per protocol removal) or early removal | 
| Technical Success of Stent Placement | Evaluation of technical success of the stent placement defined as the ability to deploy the stent in satisfactory position across the stricture as determined by cholangiogram. | At stent placement (Day 1) | 
| Effectiveness of Stent at 6 Months | Evaluation of effectiveness of the stent by assessing for resolution of stricture at 6 months as determined by cholangiogram. Effectiveness is defined as the absence of biliary obstructive symptoms after receiving a WallFlex stent. Subjects received liver function tests at the 1 Month and 6 Month post stent removal follow-up visits and were also assessed for biliary obstructive symptoms. | From stent removal through 6 months post stent removal follow-up. | 
| Re-intervention Occurrence | Evaluation of the occurrence of re-intervention. Re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage during stent indwell or through 6 months of follow-up after stent removal. | 6 months post stent removal | 
| Time to Stent Occlusion | Evidence of stent occlusion stent occlusion was assessed during the stent indwell period (from stent placement procedure through the stent removal procedure. 3 months according to protocol). Subjects received liver function tests at the 48 hour, Week 1, Month 1, and Month 3 stent indwell follow-up visits and were also asked if they were experiencing biliary obstructive symptoms at each visit. If stent occlusion was suspected, imaging and/or endoscopic intervention was performed. One subject experienced stent occlusion at 68 days post stent placement. Time to event data was not generated as not enough events occurred to calculate medial time to event data. | mean time from stent placement to stent removal for all 10 patients was 91.3 days. |