WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
This study is currently recruiting participants.
Verified April 2013 by Boston Scientific Corporation
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01543256
First received: February 14, 2012
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of ERCP procedures during 24 months.
Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.
| Condition | Intervention | Phase |
|---|---|---|
|
Biliary Stricture |
Device: WallFlex™ Biliary RX Fully Covered Stent System RMV Device: Commercially available Plastic Stent Per Investigator preference |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Prospective, Randomized Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis |
Resource links provided by NLM:
Genetics Home Reference related topics:
hereditary pancreatitis
MedlinePlus related topics:
Pancreatitis
U.S. FDA Resources
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- Stricture resolution [ Time Frame: 24 months ] [ Designated as safety issue: No ]To determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group. The null hypothesis is that the stricture resolution rate is non-inferior in the Metal Stent Arm versus the Plastic Stent Arm.
Secondary Outcome Measures:
- Occurrence of adverse events related to the stent and/or the stent placement or removal procedures. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Number of ERCP procedures through 24 months after initial stent placement. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Ability to deploy the stent(s) in satisfactory position(technical success at placement). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Ability to remove the stent(s) without serious stent removal related adverse events at each procedure involving removal of stent(s). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Liver Function Tests (LFT's) improvement at month 1 compared to baseline and at month 24 compared to removal of last stent (applicable for subjects who had not been re-stented at time of month 24 visit). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Health Economic Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]Number of outpatient procedures
- Health Economic Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]Number of hospitalizations
- Health Economic Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]Duration of hospitalizations
- Health Economic Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]Length of procedures
- Health Economic Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]Number of devices
| Estimated Enrollment: | 164 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Metal stents
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
|
Device: WallFlex™ Biliary RX Fully Covered Stent System RMV
Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
|
Active Comparator: Plastic Stents
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
|
Device: Commercially available Plastic Stent Per Investigator preference
Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
- Stricture not previously dilated
- Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at least one month or cholestasis associated with at least 3 times normal alkaline phosphatase levels)
- Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts
Exclusion Criteria:
- Biliary stricture of benign etiology other than chronic pancreatitis
- Any prior biliary stent (plastic or metal)
- Developing obstructive biliary symptoms associated with an attack of acute pancreatitis
- Biliary stricture of malignant etiology
- Stricture within 2 cm of common bile duct bifurcation
- Known bile duct fistula or leak
- Subjects for whom endoscopic techniques are contraindicated
- Known sensitivity to any components of the stent or delivery system
- Symptomatic duodenal stenosis (with gastric stasis)
- Participation in another investigational study within 90 days prior to consent
- Investigator Discretion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543256
Contacts
| Contact: Erin Leckrone | 651-582-4908 | erin.leckrone@bsci.com |
| Contact: Andrea Burbage | 508-683-4387 | andrea.burbage@bsci.com |
Locations
| Australia, New South Wales | |
| Westmead Hospital | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Michael Bourke, MD 61296891536 michael@citywestgastro.com.au | |
| Principal Investigator: Michael Bourke, MD | |
| Austria | |
| Allgemeines Krankenhaus AKH | Recruiting |
| Vienna, Austria, A-1090 | |
| Contact: Andreas Puespoek, MD 431414004375 andreas.puespoek@meduniwien.ac.at | |
| Principal Investigator: Andreas Puespoek, MD | |
| Belgium | |
| Erasme Hospital | Not yet recruiting |
| Brussels, Belgium, 1070 | |
| Contact: Jacques Deviere, MD 3225553622 jacques.deviere@erasme.ulb.ac.be | |
| Principal Investigator: Jacques Deviere, MD | |
| Canada, Quebec | |
| CHUM - Hopital Saint-Luc | Recruiting |
| Montreal, Quebec, Canada, H2X 3J4 | |
| Contact: Andre Roy, MD 5148908000 ext 36146 andre.roy.chum@ssss.gouv.qc.ca | |
| Principal Investigator: Andre Roy, MD | |
| France | |
| Hopital Edouard Herriot | Recruiting |
| Lyon, France, 69437 | |
| Contact: Thierry Ponchon, MD 0033472110146 thierry.ponchon@chu-lyon.fr | |
| Principal Investigator: Thierry Ponchon, MD | |
| Germany | |
| Evangelisches Krankenhaus Dusseldorf | Recruiting |
| Dusseldorf, Germany, D-40217 | |
| Contact: Horst Neuhaus, MD 004921191605 medizinischeklinik@evk-duesseldorf.de | |
| Principal Investigator: Horst Neuhaus, MD | |
| Hong Kong | |
| Prince of Wales Hospital | Not yet recruiting |
| Shatin, New Territories, Hong Kong | |
| Contact: James Lau, MD 85226321411 laujyw@surgery.cuhk.edu.hk | |
| Principal Investigator: James Lau, MD | |
| India | |
| Asian Institute of Gastroenterology | Recruiting |
| Hyderabad, India, 500 082 | |
| Contact: D.Nageshwar Reddy, MD 4023378888 aigindianinfo@yahoo.co.in | |
| Principal Investigator: D.Nageshwar Reddy, MD | |
| Italy | |
| Policlinico Universitario Agostino Gemelli | Recruiting |
| Rome, Italy, 00168 | |
| Contact: Guido Costamagna, MD 39063291342 gcostamagna@rm.unicatt.it | |
| Principal Investigator: Guido Costamagna, MD | |
| Netherlands | |
| Erasmus Medical Center | Recruiting |
| Rotterdam, CE, Netherlands, 3015 | |
| Contact: Marco Bruno, MD 310107035946 | |
| Principal Investigator: Marco Bruno, MD | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Principal Investigator: | D.Nageshwar Reddy, MD | Asian Institute of Gastroenterology |
More Information
No publications provided
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT01543256 History of Changes |
| Other Study ID Numbers: | CDM00047682 |
| Study First Received: | February 14, 2012 |
| Last Updated: | April 26, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: German Institute of Medical Documentation and Information Italy: Ministry of Health Netherlands: Dutch Health Care Inspectorate |
Keywords provided by Boston Scientific Corporation:
|
benign biliary strictures secondary to chronic pancreatitis |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatitis, Chronic Cholestasis Constriction, Pathologic Pancreatic Diseases |
Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013