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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent.
California Pacific Medical Center
San Francisco, California, United States
Univ. of Colorado Health Sciences
Aurora, Colorado, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Adequate Clinical Palliation of the Biliary Obstruction
Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.
Time frame: 6 months
Technical Success
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.
Time frame: At treatment
Ability to Successfully Remove a Stent Upon Removal Attempt
The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.
Time frame: 6 months
Re-interventions
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.
Time frame: Until 6 months or death
Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms
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.
Time frame: 1 Month
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Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University Med Center
Durham, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Univ. of VA Medical Center
Charlottesville, Virginia, United States
Virginia Mason Seattle Main Clinic
Seattle, Washington, United States
Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
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.
Time frame: 3 months
Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
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.
Time frame: 6 months
Bilirubin Level Reduction
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.
Time frame: 1 month
Stent Patency at 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.
Time frame: 1 month
Stent Patency at 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).
Time frame: 3 Months
Stent Patency at 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 frame: 6 Months
Time to Stent Occlusion
Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.
Time frame: Until 6 Months or death
Number of Device-Related Adverse Events
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.
Time frame: Until 6 months or death