N/A
Completed N=10
WallFlex Biliary Post Liver Transplant IDE Pilot
Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
Source: ClinicalTrials.gov NCT01151280 ↗
Enrolled (actual)
10
Serious AEs
60.0%
Results posted
Jul 2013
Primary outcomePrimary: Stricture Resolution at the Time of Stent Removal. — 9; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stricture Resolution at the Time of Stent Removal. |
9; 1 | — |
| SECONDARY Safety |
2; 2; 0 | — |
| SECONDARY Stent Removability |
9; 1 | — |
| SECONDARY Technical Success of Stent Placement |
10; 0 | — |
| SECONDARY Effectiveness of Stent at 6 Months |
6; 2; 1 | — |
| SECONDARY Re-intervention Occurrence |
4; 2; 2; 1; 1 | — |
| SECONDARY Time to Stent Occlusion |
68 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01151280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.