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Completed

NCT Number: NCT01543256

WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

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.

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Key information

Conditions

Biliary Stricture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Medical Center, Newtown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study
  • Chronic pancreatitis
  • Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at least one month or cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had one prior plastic stent inserted.12
  • Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts

Exclusion criteria

  • Biliary stricture of benign etiology other than chronic pancreatitis
  • Prior biliary metal stent or any plastic stenting other than one plastic stent of 10 Fr or less for 6 months or fewer
  • Developing obstructive biliary symptoms associated with an attack of acute pancreatitis
  • Biliary stricture of malignant etiology
  • Stricture within 2 cm of common bile duct bifurcation
  • Known bile duct fistula or leak
  • Subjects for whom endoscopic techniques are contraindicated
  • Known sensitivity to any components of the stent or delivery system
  • Symptomatic duodenal stenosis (with gastric stasis)
  • Participation in another investigational study within 90 days prior to consent
  • Investigator Discretion

Treatment and study plan

WallFlex™ Biliary RX Fully Covered Stent System RMV

Device

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 preference

Device

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.

Primary outcomes

  1. Number of Participants With Stricture Resolution

    Time frame: After 12-month stenting period through 24 month follow-up (approximately 12 months)

    Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.

Secondary outcomes

  1. Serious Adverse Events Related to the Device or Procedure

    Time frame: Initial stent placement procedure to 24 month follow-up

    Device or procedure related serious adverse events from the initial stent placement procedure to the 24 month follow-up.

  2. Number of ERCP Procedures Through 24 Months After Initial Stent Placement.

    Time frame: Initial stent placement procedure to 24 month follow-up

    The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures through 24 months, after initial stent placement.

  3. Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)

    Time frame: Initial stent placement procedure

    Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.

  4. Length of Stent Placement and Removal Procedures

    Time frame: Initial stent placement procedure to 24 month follow-up

    Length of stent placement procedures and stent removal procedures.

  5. Number of Stents Placed

    Time frame: Initial stent placement procedure to 24 month follow-up

    Number of stents placed throughout study to 24 month follow-up

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2012
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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