WallFlex Biliary Post Liver Transplant IDE Pilot

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

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.

Study Overview

• Status: Completed
• Conditions: Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
• Intervention / Treatment: Device: WallFlex Biliary Fully Covered Stent

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Mount Sinai Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Mansour Parsi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 or older

2. 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
3. Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Roux-en-Y choledochojejunostomy
2. 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)
3. Living donor transplants
4. Transplants performed within 30 days (fresh transplants)
5. Perforation of any duct within the biliary tree
6. Patients with known sensitivity to any components of the stent or delivery system
7. Patients with malignancy involving the biliary tree (including hepatocellular carcinoma)
8. Patients with poor Karnofsky score
9. Life expectancy of less than one year
10. Inability to pass a guidewire through the strictured area
11. Previous biliary metal or multiple plastic stent placement
12. Drug-induced or cholestatic hepatitis from an infective cause
13. Redundant bile duct that may be treated by temporary placement of stent or conversion to a RouxEnY hepaticojejunostomy
14. Choledocholithiasis/biliary "cast" syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Divyesh Sejpal, M.D., Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 21, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 28, 2010

Study Record Updates

• Last Update Posted (Estimate): December 25, 2013
• Last Update Submitted That Met QC Criteria: November 27, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: E7055 (Other Identifier: Boston Scientific)