WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures

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Brief Title

WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures

Official Title

Fully Covered Self Expanding Metal Stents (FCSEMS) for Pancreatic Duct Strictures in Patients With Chronic Pancreatitis

Brief Summary

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

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.
    


Study Type

Interventional


Primary Outcome

Pain Reduction

Secondary Outcome

 Stricture Resolution

Condition

Chronic Pancreatitis

Intervention

Pancreatic fully-covered self-expanding metal stent (FCSEMS)

Study Arms / Comparison Groups

 WallFlex FCSEMS Recipients
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

67

Start Date

January 25, 2017

Completion Date

September 2021

Primary Completion Date

September 2021

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jacques Deviere, MD, PhD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT02802020

Organization ID

E7104


Responsible Party

Sponsor

Study Sponsor

Boston Scientific Corporation


Study Sponsor

Jacques Deviere, MD, PhD, Principal Investigator, ULB Erasme Hospital


Verification Date

April 2021