WallFlex Biliary Fully Covered (FC) Benign Stricture Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01014390
• Collaborator: (none)
• Enrollment: 187
• Locations: 13
• Arm: 1
• Actual Duration (Months): 95
• Patients Per Site: 14.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.

Condition or Disease	Intervention/Treatment	Phase
Biliary Stricture	Device: WallFlex Biliary RX Fully Covered Stent System	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 187 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
• Actual Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: WallFlex Biliary RX FC Stent System The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.

Device: 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.

Outcome Measures

Primary Outcome Measures

1. Stent Removability [At stent removal]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 or older

• Willing and able to comply with the study procedures and provide written informed consent to participate in the study

• Chronic pancreatitis or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy)

• Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of prior plastic stent(s) for management of benign stricture

Exclusion Criteria:

General:

• Placement of the stent in strictures that cannot be dilated enough to pass the delivery system

• Placement of the stent in a perforated duct

• Placement of the stent in very small intrahepatic ducts

• Patients for whom endoscopic techniques are contraindicated

• Biliary stricture of malignant etiology

• Biliary stricture of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery

• Stricture within 2 cm of duct bifurcation

• Symptomatic duodenal stenosis (with gastric stasis)

• Prior biliary self-expanding metal stent

• Suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of biliary cast syndrome

• Known bile duct fistula

• Known sensitivity to any components of the stent or delivery system

• Participation in another investigational study within 90 days prior to consent or during the study

Additional Specific to Chronic Pancreatitis Patients:

• Developing obstructive biliary symptoms associated with an attack of acute pancreatitis

Additional Specific to Post-Abdominal Surgery Patients:

• History of hepatectomy

• History of liver transplant

Additional Specific to Liver Transplant Patients:

• Live donor transplantation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Hospital	Westmead	New South Wales	Australia	2145
2	Medical University of Vienna	Vienna		Austria
3	ULB Erasme Hospital	Brussels		Belgium
4	St. Michael's Hospital	Toronto	Ontario	Canada
5	Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital	Montreal	Quebec	Canada	H2X 3J4
6	MUHC - McGill University	Montreal	Quebec	Canada
7	Clinica Alemana de Santiago	Santiago		Chile
8	Hopital Edouard Herriot	Lyon		France
9	Evangelischen Krankenhaus	Dusseldorf		Germany
10	Asian Institute of Gastroenterology	Hyderabad		India
11	Università Cattolica del Sacro Cuore Policlinico A. Gemelli	Rome		Italy	00168
12	Erasmus Medical Center	Rotterdam		Netherlands
13	Hospital Universitari Doctor Josep Trueta	Girona	Catalunya	Spain

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Successful management of benign biliary strictures with fully covered self-expanding metal stents.

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01014390
• Other Study ID Numbers: CDM 00027550
• First Posted: Nov 17, 2009
• Last Update Posted: Feb 19, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Boston Scientific Corporation: benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant
• Additional relevant MeSH terms: Cholestasis; Constriction, Pathologic

Study Results

Participant Flow

Arm/Group Title	WallFlex Biliary RX FC Stent System
Arm/Group Description	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.
Period Title: Overall Study
STARTED	187
COMPLETED	177
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	WallFlex Biliary RX FC Stent System
Arm/Group Description	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 Participants	187
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	168 89.8%
>=65 years	19 10.2%
Sex: Female, Male (Count of Participants)
Female	42 22.5%
Male	145 77.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	18 9.6%
Netherlands	17 9.1%
Austria	24 12.8%
Belgium	27 14.4%
Italy	15 8%
France	22 11.8%
Australia	10 5.3%
Chile	3 1.6%
Germany	10 5.3%
India	34 18.2%
Spain	7 3.7%

Outcome Measures

1. Primary Outcome

Title	Stent Removability
Description	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.
Time Frame	At stent removal

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	WallFlex Biliary RX FC Stent System
Arm/Group Description	The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.
Measure Participants	177
Count of Participants [Participants]	132 70.6%

Adverse Events

Arm/Group Title	WallFlex Biliary RX FC Stent System
Arm/Group Description	evaluated for treatment of benign biliary strictures.
All Cause Mortality
	WallFlex Biliary RX FC Stent System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	WallFlex Biliary RX FC Stent System
	Affected / at Risk (%)	# Events
Total	51/187 (27.3%)
Gastrointestinal disorders
Cholangitis/fever	26/187 (13.9%)
Abdominal pain	10/187 (5.3%)
Pancreatitis	5/187 (2.7%)
Cholecystitis	3/187 (1.6%)
Cholestasis	3/187 (1.6%)
Other	9/187 (4.8%)
Other (Not Including Serious) Adverse Events
	WallFlex Biliary RX FC Stent System
	Affected / at Risk (%)	# Events
Total	0/187 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.