Trial Outcomes & Findings for Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction (NCT NCT00713427)

Last Updated: 2021-07-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

Up to 6 months post treatment or prior to death, whichever came first

Results posted on

2021-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	70
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	WallFlex Stent n=69 Participants 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.
Age, Continuous	68.6 years n=69 Participants
Sex: Female, Male Female	33 Participants n=69 Participants
Sex: Female, Male Male	36 Participants n=69 Participants
Malignant cause of bile duct stricture Pancreatic	47 Participants n=69 Participants
Malignant cause of bile duct stricture Cholangiocarcinoma	9 Participants n=69 Participants
Malignant cause of bile duct stricture Ampullary	4 Participants n=69 Participants
Malignant cause of bile duct stricture Gallbladder	3 Participants n=69 Participants
Malignant cause of bile duct stricture Metastases from colon	2 Participants n=69 Participants
Malignant cause of bile duct stricture Primary liver cancer invading common bile duct	1 Participants n=69 Participants
Malignant cause of bile duct stricture Metastases from esophageal	1 Participants n=69 Participants
Malignant cause of bile duct stricture Metastases from lung	1 Participants n=69 Participants
Malignant cause of bile duct stricture Metastases from breast	1 Participants n=69 Participants
Stricture location Distal common bile duct	46 Participants n=69 Participants
Stricture location Mid common bile duct	15 Participants n=69 Participants
Stricture location Papilla	6 Participants n=69 Participants
Stricture location Proximal common bile duct	2 Participants n=69 Participants
Number of study stents placed number of 60mm x10mm stents placed	54 Stents n=69 Participants
Number of study stents placed number of 40mm x 10mm stents placed	13 Stents n=69 Participants
Number of study stents placed number of 80mm x10mm stents placed	3 Stents n=69 Participants
Number of study stents placed number of 60mm x 8mm stents placed	1 Stents n=69 Participants

PRIMARY outcome

Timeframe: Up to 6 months post treatment or prior to death, whichever came first

Outcome measures

Outcome measures
Measure	WallFlex Stent n=66 Participants 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.
Number of Participants With Absence of Recurrent Biliary Obstruction	62 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	WallFlex Stent n=69 Participants 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.
Number of Adverse Events Related to the Device and/or Procedure	9 related adverse events

SECONDARY outcome

Timeframe: Initial stent placement procedure

Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture

Outcome measures

Outcome measures
Measure	WallFlex Stent n=69 Participants 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.
Number of Participants With Technical Stent Placement Success	68 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	WallFlex Stent n=66 Participants 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.
Number of Participants With Occurrence of Re-intervention	6 Participants

SECONDARY outcome

Timeframe: up to 6 months post-initial study treatment

Incidence of symptoms of biliary obstruction

Outcome measures

Outcome measures
Measure	WallFlex Stent n=29 Participants 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.
Change in Biliary Obstruction Symptoms	.62 count of symptoms Standard Deviation .98

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	WallFlex Stent n=66 Participants 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.
Time to Recurrent Biliary Obstruction	110 days Standard Deviation 63

SECONDARY outcome

Timeframe: 1 month following stent placement

Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline.

Outcome measures

Outcome measures
Measure	WallFlex Stent n=66 Participants 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.
Change in Bilirubin	-1.9 mg/dL Standard Deviation 2.2

Adverse Events

WallFlex Stent

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	WallFlex Stent n=69 participants at risk 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.
Gastrointestinal disorders Recurrent Biliary Obstruction	5.8% 4/69 • Number of events 4 • Adverse event data collected from the time the participant signed the informed consent until completion of the 6 month follow-up visit (occurring 6 months post-initial study treatment) Reported on Adverse Events (Serious and Non-serious) related to the device and/or procedure.
Gastrointestinal disorders Cholecystitis	4.3% 3/69 • Number of events 3 • Adverse event data collected from the time the participant signed the informed consent until completion of the 6 month follow-up visit (occurring 6 months post-initial study treatment) Reported on Adverse Events (Serious and Non-serious) related to the device and/or procedure.
Gastrointestinal disorders Pancreatitis	1.4% 1/69 • Number of events 1 • Adverse event data collected from the time the participant signed the informed consent until completion of the 6 month follow-up visit (occurring 6 months post-initial study treatment) Reported on Adverse Events (Serious and Non-serious) related to the device and/or procedure.
Gastrointestinal disorders Right Upper Quadrant Pain	1.4% 1/69 • Number of events 1 • Adverse event data collected from the time the participant signed the informed consent until completion of the 6 month follow-up visit (occurring 6 months post-initial study treatment) Reported on Adverse Events (Serious and Non-serious) related to the device and/or procedure.

Other adverse events

Adverse event data not reported

Additional Information

Joyce Peetermans, PhD - Vice President, Global Clinical Programs

Boston Scientific Corporation

Phone: 508-683-4211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60