WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures

NCT ID: NCT02802020

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-25
• Study Completion Date: 2021-11-24

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.

Conditions

Chronic Pancreatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

WallFlex

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Deviere, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ULB Erasme Hospital

Locations

University of Colorado School of Medicine

Aurora, Colorado, United States

Indiana University Health Medical Center

Indianapolis, Indiana, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Methodist Dallas Medical Center

Dallas, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

ULB Erasme Hospital

Brussels, , Belgium

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, India

Policlinico A. Gemelli

Rome, , Italy

Erasmus Medical Center

Rotterdam, , Netherlands

Countries

United States; Belgium; Canada; India; Italy; Netherlands

References

Sherman S, Kozarek RA, Costamagna G, Reddy DN, Tarnasky P, Shah RJ, Slivka A, Fogel E, Watkins J, Delhaye M, Irani SS, Tringali A, Lakhtakia S, Kedia P, Edmundowicz S, Peetermans JA, Rousseau MJ, Deviere J; Pancreatic SEMS in Chronic Pancreatitis Study Group. Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial. Gastrointest Endosc. 2023 Mar;97(3):472-481.e3. doi: 10.1016/j.gie.2022.09.021. Epub 2022 Oct 5.

Reference Type: DERIVED

PMID: 36208796 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

E7104

Identifier Type: -

Identifier Source: org_study_id