WallFlex Biliary Post Liver Transplant IDE Pilot
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|ClinicalTrials.gov Identifier: NCT01151280|
Recruitment Status : Completed
First Posted : June 28, 2010
Results First Posted : July 19, 2013
Last Update Posted : December 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Anastomotic Biliary Stricture Post Orthotopic Liver Transplant||Device: WallFlex Biliary Fully Covered Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151280
|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|
|Principal Investigator:||Divyesh Sejpal, M.D.||Icahn School of Medicine at Mount Sinai|