Cholestasis, Extrahepatic
Conditions
Keywords
Malignant, Cholestasis, Extrahepatic, Biliary 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.
Interventions
DEVICEWallFlex™ Biliary Fully Covered Metal Stent placement
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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Clinical symptoms of biliary obstruction * Inoperable extrahepatic biliary obstruction by any malignant process * Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion criteria
* Participation in an Investigational Study within 90 days prior to date of patient consent * Strictures that cannot be dilated enough to pass the delivery system * Perforation of any duct within the biliary tree * Presence of a metal biliary stent * Presence of any esophageal or duodenal stent * Patients for whom endoscopic procedures are contraindicated * Patients with known sensitivity to any components of the stent or delivery system * Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver * Patients with an anticipated life expectancy of \< 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate Clinical Palliation of the Biliary Obstruction | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | 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 | 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. |
| Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms | 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 | 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 | 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. |
| Re-interventions | 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. |
| Stent Patency at 1 Month | 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 | 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 | 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 | 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 | 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. |
| Bilirubin Level Reduction | 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. |
Countries
United States
Participant flow
Recruitment details
Enrollment complete
Participants by arm
| Arm | Count |
|---|---|
| WallFlex Biliary Fully Covered Stent Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Failure to deploy stent | 1 |
| Overall Study | screen fail | 14 |
| Overall Study | Treated and later found to be ineligible | 2 |
Baseline characteristics
| Characteristic | WallFlex Biliary Fully Covered Stent |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 38 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age Continuous | 67.91 years STANDARD_DEVIATION 14.35 |
| Region of Enrollment United States | 58 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 58 |
| serious Total, serious adverse events | 45 / 58 |
Outcome results
Primary
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
Population: Per protocol, assessment of the primary endpoint was performed on the evaluable cohort, defined as group of patients who signed the Informed Consent Form, met eligibility criteria, received a stent and had at least one week of follow up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Adequate Clinical Palliation of the Biliary Obstruction | 54 participants |
Secondary
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
Population: 2 patients of the evaluable cohort (n=55) were assessed for success of stent removal without any complications/technical difficulties.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Ability to Successfully Remove a Stent Upon Removal Attempt | 2 Participants |
Secondary
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
Population: 45 out of 55 evaluable patients reported a baseline and a Month 1 total bilirubin level and were therefore analyzed for bilirubin levels reduction.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Bilirubin Level Reduction | 44 Participants |
Secondary
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
Population: 49 out of 55 evaluable subjects reached the 1-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms | 45 Participants |
Secondary
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
Population: 34 out of 55 evaluable subjects reached the 3-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms compared to baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms | 33 Participants |
Secondary
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
Population: 23 out of 55 evaluable subjects reached the 6-Month follow up visit and were assessed for reduction of biliary obstructive symptoms compared to baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms | 23 Participants |
Secondary
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
Population: The intent-to-treat cohort of 58 patients was used for this analysis. Of all the events reported for this population, only 6 events were reported as device-related.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Number of Device-Related Adverse Events | 6 Events |
Secondary
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
Population: The re-intervention rate was assessed in the evaluable cohort of 55 patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Re-interventions | 1 Participant |
Secondary
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
Population: 45 out of 55 evaluable patients had both bilirubin and obstructive symptom assessment at Month 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Stent Patency at 1 Month | 44 Participants |
Secondary
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
Population: 34 patients reached the Month 3 follow up point and were evaluated for stent patency.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Stent Patency at 3 Months | 31 Participants |
Secondary
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
Population: 23 patients reached the Month 6 follow up point and were evaluated for stent patency.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Stent Patency at 6 Months | 21 Participants |
Secondary
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
Population: Device Safety and Technical Success were evaluated for the 58 intent-to-treat patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Technical Success | 57 participants |
Secondary
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
Population: Only 1 subject experienced stent occlusion during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Time to Stent Occlusion | 142 Days |