Trial Outcomes & Findings for WallFlex Biliary Fully Covered (FC) Benign Stricture Study (NCT NCT01014390)

NCT ID: NCT01014390

Last Updated: 2020-02-19

Results Overview

Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 187 participants
• Primary outcome timeframe: At stent removal
• Results posted on: 2020-02-19

Participant Flow

Participant milestones

Measure	WallFlex Biliary RX FC Stent System The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures. WallFlex Biliary RX Fully Covered Stent System: Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.
Overall Study STARTED	187
Overall Study COMPLETED	177
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	WallFlex Biliary RX FC Stent System n=187 Participants The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures. WallFlex Biliary RX Fully Covered Stent System: Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.
Age, Categorical <=18 years	0 Participants n=187 Participants
Age, Categorical Between 18 and 65 years	168 Participants n=187 Participants
Age, Categorical >=65 years	19 Participants n=187 Participants
Sex: Female, Male Female	42 Participants n=187 Participants
Sex: Female, Male Male	145 Participants n=187 Participants
Region of Enrollment Canada	18 participants n=187 Participants
Region of Enrollment Netherlands	17 participants n=187 Participants
Region of Enrollment Austria	24 participants n=187 Participants
Region of Enrollment Belgium	27 participants n=187 Participants
Region of Enrollment Italy	15 participants n=187 Participants
Region of Enrollment France	22 participants n=187 Participants
Region of Enrollment Australia	10 participants n=187 Participants
Region of Enrollment Chile	3 participants n=187 Participants
Region of Enrollment Germany	10 participants n=187 Participants
Region of Enrollment India	34 participants n=187 Participants
Region of Enrollment Spain	7 participants n=187 Participants

PRIMARY outcome

Timeframe: At stent removal

Population: 10 Patients were excluded because of death (from unrelated cause), withdrawal of consent, or switch to palliative treatment.

Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal.

Outcome measures

Measure	WallFlex Biliary RX FC Stent System n=177 Participants The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.
Stent Removability	132 Participants

Adverse Events

WallFlex Biliary RX FC Stent System

Serious events: 51 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	WallFlex Biliary RX FC Stent System n=187 participants at risk evaluated for treatment of benign biliary strictures.
Gastrointestinal disorders Cholangitis/fever	13.9% 26/187
Gastrointestinal disorders Abdominal pain	5.3% 10/187
Gastrointestinal disorders Pancreatitis	2.7% 5/187
Gastrointestinal disorders Cholecystitis	1.6% 3/187
Gastrointestinal disorders Cholestasis	1.6% 3/187
Gastrointestinal disorders Other	4.8% 9/187

Other adverse events

Adverse event data not reported

Additional Information

Jacques Devière, MD, PhD

Hôpital Erasme

Phone: (32) 0-2-555-4697.

Email: Jacques.Deviere@erasme.ulb.ac.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place