CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 172 enrolled
Drug / intervention
WallFlex™ Biliary RX Fully Covered Stent System RMV +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01543256
NCT01543256N/ACompleted
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A Multi-Center, Prospective, Randomized Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis

Boston Scientific Corporation·interventional·Posted Mar 2, 2012·Updated Jan 9, 2023

In Brief

A clinical study evaluating WallFlex™ Biliary RX Fully Covered Stent System RMV and Commercially available Plastic Stent Per Investigator preference for Biliary Stricture. Completed, enrolled 172 participants across 14 sites in 11 countries.

Detailed Summary

The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during 24 months. Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Stricture
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Hong Kong, India, Italy, Netherlands, Sweden
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2012
Enrollment StartSep 18, 2012
Primary CompletionSep 21, 2020
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 14.3 years ago

Interventions

WallFlex™ Biliary RX Fully Covered Stent System RMVdevice

Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell. ("RMV" in intervention name indicates "removable")

Commercially available Plastic Stent Per Investigator preferencedevice

Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.