WallFlex Biliary Post Liver Transplant IDE Pilot

• ClinicalTrials.gov Identifier: NCT01151280
• Recruitment Status: Completed
• First Posted: June 28, 2010
• Results First Posted: July 19, 2013
• Last Update Posted: December 25, 2013
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anastomotic Biliary Stricture Post Orthotopic Liver Transplant	Device: WallFlex Biliary Fully Covered Stent	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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.
• Study Start Date: October 2009
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.

2. 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.
3. 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.
4. 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.

5. 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.
6. 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New York

Mount Sinai Medical Center

New York, New York, United States, 10017

United States, Ohio

Mansour Parsi, MD

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

• Principal Investigator: Divyesh Sejpal, M.D.; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01151280
• Other Study ID Numbers: E7055; E7055 ( Other Identifier: Boston Scientific )
• First Posted: June 28, 2010
• Results First Posted: July 19, 2013
• Last Update Posted: December 25, 2013
• Last Verified: November 2013

Additional relevant MeSH terms:

Constriction, Pathologic; Pathological Conditions, Anatomical