Completed

NCT Number: NCT01151280

WallFlex Biliary Post Liver Transplant IDE Pilot

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.

Completed

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Key information

Conditions

Anastomotic Biliary Stricture Post Orthotopic Liver Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Medical Center, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WallFlex Biliary Fully Covered Stent

Device

Investigational device evaluated for the treatment for benign biliary strictures

Primary outcomes

Stricture Resolution at the Time of Stent Removal.

Time frame: 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 outcomes

Safety

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.
Re-intervention Occurrence

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Jun 28, 2010
Registry last updated: Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.