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WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

NCT01543256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2023-01-09

Study results available
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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.

Conditions

  • Biliary Stricture

Interventions

DEVICE

WallFlex™ Biliary RX Fully Covered Stent System RMV

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")

DEVICE

Commercially available Plastic Stent Per Investigator preference

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • D.Nageshwar Reddy, MD · Asian Institute of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-18
Primary Completion
2020-09-21
Completion
2020-09-21

Countries

  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Netherlands
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01543256 on ClinicalTrials.gov