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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01014390




Registration number
NCT01014390
Ethics application status
Date submitted
13/11/2009
Date registered
17/11/2009
Date last updated
19/02/2020

Titles & IDs
Public title
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Scientific title
A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
Secondary ID [1] 0 0
CDM 00027550
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biliary Stricture 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - WallFlex Biliary RX Fully Covered Stent System

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


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stent Removability
Timepoint [1] 0 0
At stent removal

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2017
Sample size
Target
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
France
State/province [6] 0 0
Lyon
Country [7] 0 0
Germany
State/province [7] 0 0
Dusseldorf
Country [8] 0 0
India
State/province [8] 0 0
Hyderabad
Country [9] 0 0
Italy
State/province [9] 0 0
Rome
Country [10] 0 0
Netherlands
State/province [10] 0 0
Rotterdam
Country [11] 0 0
Spain
State/province [11] 0 0
Catalunya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01014390
Trial related presentations / publications
Deviere J, Nageshwar Reddy D, Puspok A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliary Stenoses Working Group. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4.
Poley JW, Ponchon T, Puespoek A, Bruno M, Roy A, Peetermans J, Rousseau M, Lepilliez V, Dolak W, Tringali A, Blero D, Carr-Locke D, Costamagna G, Deviere J; Benign Biliary Stenoses Working Group. Fully covered self-expanding metal stents for benign biliary stricture after orthotopic liver transplant: 5-year outcomes. Gastrointest Endosc. 2020 Dec;92(6):1216-1224. doi: 10.1016/j.gie.2020.04.078. Epub 2020 May 15.
Tringali A, Reddy DN, Ponchon T, Neuhaus H, Llado FG, Navarrete C, Bruno MJ, Kortan PP, Lakhtakia S, Peetermans J, Rousseau M, Carr-Locke D, Deviere J, Costamagna G; Benign Biliary Stenoses Working Group. Treatment of post-cholecystectomy biliary strictures with fully-covered self-expanding metal stents - results after 5 years of follow-up. BMC Gastroenterol. 2019 Dec 12;19(1):214. doi: 10.1186/s12876-019-1129-3.
Lakhtakia S, Reddy N, Dolak W, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Kortan PP, Peetermans J, Rousseau M, Costamagna G, Deviere J; Benign Biliary Stenoses Working Group. Long-term outcomes after temporary placement of a self-expanding fully covered metal stent for benign biliary strictures secondary to chronic pancreatitis. Gastrointest Endosc. 2020 Feb;91(2):361-369.e3. doi: 10.1016/j.gie.2019.08.037. Epub 2019 Sep 5.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01014390