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WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures

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ClinicalTrials.gov Identifier: NCT02802020
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
To prospectively document the performance of a FCSEMS for treatment of pancreatic duct strictures in patients with painful chronic pancreatitis.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Device: Pancreatic fully-covered self-expanding metal stent (FCSEMS) Not Applicable

Detailed Description:
This study is a prospective, single arm, pre-approval study. Treatment of up to 92 patients will take place at up to 15 clinical centers. Patient who meet all eligibility criteria will receive the WallFlex Pancreatic stent for up to 6 months stent indwell and 6 months follow-up after stent removal.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fully Covered Self Expanding Metal Stents (FCSEMS) for Pancreatic Duct Strictures in Patients With Chronic Pancreatitis
Actual Study Start Date : January 25, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: WallFlex FCSEMS Recipients
The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent. Patients who meet all eligibility criteria will receive the WallFlex Pancreatic stent for up to 6 months stent indwell and 6 months follow-up after stent removal. A patient is considered "enrolled" after signing the study-specific Informed Consent Form (ICF). Patients who sign the ICF but subsequently do not meet one or more of the selection criteria will be considered screen failures and excluded from the study.
Device: Pancreatic fully-covered self-expanding metal stent (FCSEMS)
The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.
Other Name: WallFlex




Primary Outcome Measures :
  1. Pain Reduction [ Time Frame: Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration ]
    Pain reduction will be assessed at 6 months post-stent removal or 6 months post-observation of complete or partial stent migration compared to pain collected at baseline. Pain will be scored between 0 and 100 as the mean of the VAS Pain Score and Frequency of Pain sectors of the Izbicki pain scale.

  2. Rate of Related SAEs from WallFlex Pancreatic stent placement to end of study [ Time Frame: Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration ]
    Relatedness of severe adverse events from WallFlex Pancreatic stent will be assessed throughout the study. Relatedness will be determined by the PI, reporting if the SAE is related to the study stenting procedure, to the indwelling study stent, to study stent removal and/or to study stent migration.


Secondary Outcome Measures :
  1. Stricture Resolution [ Time Frame: Stricture resolution assessed through study completion, 6 months after removal of the study stent. ]
    Stricture resolution is defined as maintained pain relief without need for restenting or, if pain recurs, confirmation of stent patency adequate for providing drainage of the pancreatic duct.

  2. Improved Clinical Status [ Time Frame: Baseline through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration ]
    Improved clinical status will be assessed at each visit and is defined as improvement in at least one and deterioration in none of the following: Pain, Weight and Quality of Life (QOL).

  3. Recurrence of Stricture [ Time Frame: Study stent implant through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration ]
    This will be documented by recurrence of pain with loss of adequate pancreatic duct drainage. Recurrence of stricture is defined as need for restenting.

  4. Stent Functionality [ Time Frame: Approximately 6 months. Stent functionality will be assessed from stent placement until stent removal or observation of complete or partial stent migration. ]
    Stent functionality is defined as adequate pancreatic duct drainage reflected by reduction of pain and lack of restenting.

  5. The Izbicki pain scale [ Time Frame: Baseline through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration ]
    The Izbicki pain scale has four sectors related to severity of pain, frequency of pain, analgesic medication, and disease-related inability to work.

  6. Average Daily Narcotic Dose [ Time Frame: Baseline through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration ]
    Average daily narcotic dose will be assessed for prior month at each study visit.

  7. Maintenance of VAS and Frequency of Pain Scores [ Time Frame: Baseline through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration ]
    Maintenance of the VAS Pain Score and Frequency of Pain Score recorded at 6 months post-stent removal compared with that recorded at the time of plastic stent removal, for patients requiring ESWL. Pain will be scored between 0 and 100 as the mean of the VAS Pain Score and Frequency of Pain sectors of the Izbicki pain scale.

  8. Stent Placement Success [ Time Frame: Assessed upon study stent placement. This endpoint is assessed at the Study Stent Placement visit (Day 0). ]
    Ease of placement will also be assessed.on a 5 point Likert scale. Satisfactory position is defined as the stent being across the stricture, without visible occluding impaction at the genu of the pancreatic duct and with distal end of the stent visible in the duodenum.

  9. Endoscopic Stent Removal Success [ Time Frame: Assessed at study stent removal or observation of complete or partial stent migration. This is endpoint is assessed through the Month 6 Study Stent Removal visit. ]
    Endoscopic stent removal success is defined as ability to remove stent endoscopically (forceps, snare) without serious stent removal-related adverse events. Ease of removal will also be assessed.on a 5 point Likert scale.

  10. Safety and Device Events [ Time Frame: Baseline through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration ]
    Device Events, including findings not associated with adverse events, such as but not limited to asymptomatic stent migration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
  • Chronic pancreatitis induced stricture of Cremer Type IV, namely distal dominant stricture with upstream ductal dilation.
  • For patients with one prior plastic pancreatic stent: VAS Pain Score and Frequency of Pain sectors of the Izbicki pain scale at the time of placement of the plastic stent.
  • Availability of narcotic dosage for at least one month prior to baseline visit for patients who do not have a prior plastic stent or availability for one month prior to placement of prior plastic stent, where applicable.
  • VAS Pain Score of ≥ 20 before study stent placement for patients without a prior plastic pancreatic stent. VAS Pain Score of ≥ 20 before initial plastic pancreatic stent placement for patients with a prior plastic pancreatic stent indwelling for 90 days or less before study stent placement. VAS Pain Score is captured via Izbicki pain scale.
  • Pain occurring weekly or more frequently (assessed by Frequency of Pain sector of the Izbicki pain scale) as reported before study stent placement for patients without a prior plastic pancreatic stent, or before placement of initial plastic pancreatic stent for patients with a prior plastic pancreatic stent indwelling for 90 days or less before study stent placement.
  • Minimum 5 mm diameter of dilated duct immediately upstream of pancreatic duct stricture
  • Prior clearance of pancreatic stones where needed

    • If pancreatic duct stone clearance prior to placement of the study stent includes ESWL, then a plastic pancreatic stent may be placed immediately after the ESWL procedure at the discretion of the Investigator, for example, if there is concern about stone fragments of stone sludge in side branches of the pancreatic duct, and may be left indwelling for 30-90 days.
    • If new pancreatic duct stones requiring ESWL have formed by the time of intended study stent placement, then the patient will not receive the study stent and be excluded from the study. Further treatment of the patient will be provided per standard of practice outside of the study. In case the study stent is not placed during the same session in which the plastic stent is removed, the pain score needs to be collected again prior to study stent placement.
  • Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement as applicable.

Exclusion Criteria:

  • Pancreatic or peri-ampullary cancer with or without pancreatic duct strictures caused by malignancy
  • Biliary strictures caused by chronic pancreatitis that are symptomatic and/or in need of therapeutic intervention
  • Perforated duct
  • Ansa pancreatica
  • Presence of pancreatic cysts suspected to be cystic tumor or requiring transmural drainage
  • Duodenal/groove pancreatitis
  • Autoimmune pancreatitis
  • Pancreatic duct stenoses not located in the head of the pancreas
  • Failed access during an attempted ERCP on a prior date at the investigational center
  • Duration of indwell of one single plastic pancreatic stent or cumulative duration of consecutive single plastic pancreatic stents immediately prior to study stent placement exceeding 90 days
  • History of prior single pancreatic plastic stent(s) followed by a stent-free period shorter than 1 year before enrollment into the study
  • History of prior side-by-side multiple pancreatic plastic stents up to one year prior to enrollment
  • History of prior pancreatic metal stent(s)
  • Reported recent history of acute relapsing pancreatitis in the absence of chronic pancreatitis
  • Patients for whom endoscopic techniques are contraindicated
  • Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
  • Inability or refusal to comply with the follow-up schedule including patients living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802020


Contacts
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Contact: Brian Vatcher (508) 683-5274 brian.vatcher@bsci.com
Contact: Shay Caravaggio (508) 683-5296 shay.caravaggio@bsci.com

Locations
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United States, Colorado
University of Colorado School of Medicine Recruiting
Aurora, Colorado, United States, 80045
Contact: Angelina Miley    303-724-9228    angelina.miley@cuanschutz.edu   
United States, Indiana
Indiana University Health Medical Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Laura Mathews    412-624-3096    ljm96@pitt.edu   
Contact: Kelley Wood    412-648-7442    etheringtonka@upmc.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Reshil-Marie Dukes    843-792-0387    dukesre@musc.edu   
United States, Texas
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75208
Contact: Seena Arol    214-947-4068    seenaarol@mhd.com   
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Katharyn Gelinas    206-341-1992    Katharyn.Gelinas@virginiamason.org   
Belgium
ULB Erasme Hospital Recruiting
Brussels, Belgium
Contact: Mona Hammam    +32 (0) 2 555 47 64    mona.hammam@erasme.ulb.ac.be   
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal Recruiting
Montreal, Quebec, Canada, H2X 3J4
Contact: Alexia Monges    514-890-8000 ext 30655    alexia.monges.chum@ssss.gouv.qc.ca   
India
Asian Institute of Gastroenterology Recruiting
Hyderabad, Andhra Pradesh, India, 500 082
Contact: Sana Fatima    +91 40-23378888 ext 802    sana.aigindia@gmail.com   
Italy
Policlinico A. Gemelli Recruiting
Rome, Italy, 00168
Contact: Carolina Gualtieri    +39 06-30156580    carolina.gualtieri@rm.unicatt.it   
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Heleen van Santen    +31 (0)10 7040704    mdltrial.crb@erasmusmc.nl   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Jacques Deviere, MD, PhD ULB Erasme Hospital

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02802020     History of Changes
Other Study ID Numbers: E7104
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases