Biliary Strictures Caused by Malignant Neoplasms
Conditions
Keywords
Biliary, Strictures, Malignant, Neoplasm, Palliation
Brief summary
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.
Interventions
DEVICEWallFlex™ Biliary Partially-Covered Stent
Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
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 years or older * Inoperable extrahepatic biliary obstruction by any malignant process * Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms * Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Exclusion criteria
* Participation in another invesitgational study within 90 days prior to date of patient consent. * Strictures that cannot be dialated enough to pass the delivery system * Perforation of any duct within the biliary tree * Presence of any esophageal or duodenal stent * Patients for whom endoscopic procedures are contraindicated * Patients with known senesitivity to any components of the stent or delivery system * Patients with active hepatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Absence of Recurrent Biliary Obstruction | Up to 6 months post treatment or prior to death, whichever came first | Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Technical Stent Placement Success | Initial stent placement procedure | Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture |
| Number of Participants With Occurrence of Re-intervention | Up to 6 months post-initial study treatment | A re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial study stent. Re-intervention does not include a second WallFlex stent placement during the 7 days post initial placement as a second stent could have been placed due to misplacement or failure to cover the entire stricture. |
| Number of Adverse Events Related to the Device and/or Procedure | From time participant signs informed consent until time participant exits study (up to 6 months following stent placement) | Number of adverse events (serious and non-serious) related to the device and/or procedure were collected following informed consent, treatment, and at all follow-up timepoints. |
| Time to Recurrent Biliary Obstruction | Up to 6 months | Biliary obstruction symptoms were collected at all follow-up visits post treatment and included but not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. The time to recurrent biliary obstruction was recorded. |
| Change in Bilirubin | 1 month following stent placement | Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline. |
| Change in Biliary Obstruction Symptoms | up to 6 months post-initial study treatment | Incidence of symptoms of biliary obstruction |
Countries
Belgium, France, Germany, India, Italy, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WallFlex Stent All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.
WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent. | 69 |
| Total | 69 |
Baseline characteristics
| Characteristic | WallFlex Stent | — |
|---|---|---|
| Age, Continuous | 68.6 years | — |
| Malignant cause of bile duct stricture Ampullary | 4 Participants | — |
| Malignant cause of bile duct stricture Cholangiocarcinoma | 9 Participants | — |
| Malignant cause of bile duct stricture Gallbladder | 3 Participants | — |
| Malignant cause of bile duct stricture Metastases from breast | 1 Participants | — |
| Malignant cause of bile duct stricture Metastases from colon | 2 Participants | — |
| Malignant cause of bile duct stricture Metastases from esophageal | 1 Participants | — |
| Malignant cause of bile duct stricture Metastases from lung | 1 Participants | — |
| Malignant cause of bile duct stricture Pancreatic | 47 Participants | — |
| Malignant cause of bile duct stricture Primary liver cancer invading common bile duct | 1 Participants | — |
| Number of study stents placed number of 40mm x 10mm stents placed | 13 Stents | — |
| Number of study stents placed number of 60mm x10mm stents placed | 54 Stents | — |
| Number of study stents placed number of 60mm x 8mm stents placed | 1 Stents | — |
| Number of study stents placed number of 80mm x10mm stents placed | 3 Stents | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 33 Participants | — |
| Sex: Female, Male Male | 36 Participants | — |
| Stricture location Distal common bile duct | 46 Participants | — |
| Stricture location Mid common bile duct | 15 Participants | — |
| Stricture location Papilla | 6 Participants | — |
| Stricture location Proximal common bile duct | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 69 |
| other Total, other adverse events | 0 / 69 |
| serious Total, serious adverse events | 9 / 69 |
Outcome results
Primary
Number of Participants With Absence of Recurrent Biliary Obstruction
Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points.
Time frame: Up to 6 months post treatment or prior to death, whichever came first
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Stent | Number of Participants With Absence of Recurrent Biliary Obstruction | 62 Participants |
Secondary
Change in Biliary Obstruction Symptoms
Incidence of symptoms of biliary obstruction
Time frame: up to 6 months post-initial study treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WallFlex Stent | Change in Biliary Obstruction Symptoms | .62 count of symptoms | Standard Deviation 0.98 |
Secondary
Change in Bilirubin
Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline.
Time frame: 1 month following stent placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WallFlex Stent | Change in Bilirubin | -1.9 mg/dL | Standard Deviation 2.2 |
Secondary
Number of Adverse Events Related to the Device and/or Procedure
Number of adverse events (serious and non-serious) related to the device and/or procedure were collected following informed consent, treatment, and at all follow-up timepoints.
Time frame: From time participant signs informed consent until time participant exits study (up to 6 months following stent placement)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Stent | Number of Adverse Events Related to the Device and/or Procedure | 9 related adverse events |
Secondary
Number of Participants With Occurrence of Re-intervention
A re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial study stent. Re-intervention does not include a second WallFlex stent placement during the 7 days post initial placement as a second stent could have been placed due to misplacement or failure to cover the entire stricture.
Time frame: Up to 6 months post-initial study treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Stent | Number of Participants With Occurrence of Re-intervention | 6 Participants |
Secondary
Number of Participants With Technical Stent Placement Success
Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture
Time frame: Initial stent placement procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WallFlex Stent | Number of Participants With Technical Stent Placement Success | 68 Participants |
Secondary
Time to Recurrent Biliary Obstruction
Biliary obstruction symptoms were collected at all follow-up visits post treatment and included but not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. The time to recurrent biliary obstruction was recorded.
Time frame: Up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WallFlex Stent | Time to Recurrent Biliary Obstruction | 110 days | Standard Deviation 63 |