Clinical Trial: A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Brief Summary: The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.

Detailed Summary:
Sponsor: Boston Scientific Corporation

Current Primary Outcome: Adequate Clinical Palliation of the Biliary Obstruction [ Time Frame: 6 months ]

Original Primary Outcome: Adequate clinical palliation of the biliary obstruction demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first

Current Secondary Outcome:

• Technical Success [ Time Frame: At treatment ]
  Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort.
• Ability to Successfully Remove a Stent Upon Removal Attempt [ Time Frame: 6 months ]
  The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.
• Re-interventions [ Time Frame: Until 6 months or death ]
  Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent.
• Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms [ Time Frame: 1 Month ]
  Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment.
• Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms [ Time Frame: 3 months ]
  Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment.
• Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms [ Time Frame: 6 months ]
  Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment.
• Bilirubin Level Reduction [ Time Frame: 1 month ]
  Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl.
• Stent Patency at 1 Month [ Time Frame: 1 month ]
  Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms.
• Stent Patency at 3 Months [ Time Frame: 3 Months ]
  Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3).
• Stent Patency at 6 Months [ Time Frame: 6 Months ]
  Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6).
• Time to Stent Occlusion [ Time Frame: Until 6 Months or death ]
  Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.
• Number of Device-Related Adverse Events [ Time Frame: Until 6 months or death ]
  Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant.

Original Secondary Outcome: Evaluation of safety, technical success of the stent placement, stent removability, re-interventions, clinical success, bilirubin level, stent patency, time to stent occlusion

Information By: Boston Scientific Corporation

Dates:
Date Received: February 8, 2007
Date Started: March 2007
Date Completion:
Last Updated: June 21, 2010
Last Verified: June 2010