WallFlex Biliary Post Liver Transplant IDE Pilot

Not Applicable

Completed

Conditions: Anastomotic Biliary Stricture Post Orthotopic Liver Transplant

Interventions: Device: WallFlex Biliary Fully Covered Stent

Registration Number: NCT01151280

Lead Sponsor: Boston Scientific Corporation

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WallFlex Biliary Fully Covered Stent	WallFlex Biliary Fully Covered Stent	All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent

Primary Outcome Measures

Name	Time	Method
Stricture Resolution at the Time of Stent Removal.	At 3 months (per protocol removal) or at early 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.

Secondary Outcome Measures

Name	Time	Method
Re-intervention Occurrence	6 months post stent removal	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.
Time to Stent Occlusion	mean time from stent placement to stent removal for all 10 patients was 91.3 days.	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.
Safety	From enrollment through end of study.	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.
Stent Removability	At 3 months (per protocol removal) or early removal	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.
Technical Success of Stent Placement	At stent placement (Day 1)	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.
Effectiveness of Stent at 6 Months	From stent removal through 6 months post stent removal follow-up.	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.