WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures

NCT02802020 | Completed Results FDA Device

• 1 other identifier: E7104
• Study Type: interventional
• Target: 67
• Locations: 6 countries
• Sites: 11

Brief Summary

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

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (2)

• Pain Reduction

  The self-reported pain score (0-100) was the mean of the Visual Analogue Scale (VAS) and Izbicki Frequency of Pain subscore (sum treated as a continuous variable).The primary efficacy endpoint was the proportion of patients who had complete (pain score ≤ 10) or partial (pain score ˃ 10 but reduced at least 50% compared to pain as baseline) pain relief by 6 months after FCSEMS removal or observation of CDM or partial stent migration. Primary efficacy endpoint failure included any of the following: 1) no pain relief, 2) complete or partial pain relief in the setting of a 50% higher average daily narcotic dose compared to the patient's daily average narcotic dose in the month prior to baseline and at 6 months post-stent removal/observation of CDM, 3) stent migration in setting of recurring pain (VAS Pain Score of ≥ 20), 4) restenting in the setting of recurring pain.

  Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

• Rate of Related SAEs From WallFlex Pancreatic Stent Placement to End of Study

  The primary safety endpoint was the rate of serious adverse events (SAEs) related to the FCSEMS or study procedures from FCSEMS placement to end of study follow-up. Pain thought to be caused by FCSEMS pancreatic stent expansion was reported but did not count towards the endpoint if all three of the following conditions applied: 1. Pain managed by medication, with the exception of injectable narcotic use for more than 24 hours. 2. Pain not causing pancreatic FCSEMS removal. 3. Pain resolved by 72 hours after pancreatic FCSEMS placement.

  Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

Secondary Outcomes (5)

• Stent Placement Success

  Assessed upon study stent placement. This endpoint is assessed at the Study Stent Placement visit (Day 0).

• Endoscopic Stent Removal Success

  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.

• Stent Migration Rate

  Study stent placement through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

• Restenting Rate

  Study stent removal or observation of study stent migration through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

• Secondary Stricture Rate

  Study stent placement through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration

Study Arms (1)

WallFlex FCSEMS Recipients

EXPERIMENTAL

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)

Interventions

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

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

Also known as: WallFlex

WallFlex FCSEMS Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (11)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Indiana University Health Medical Center

Indianapolis, Indiana, 46202, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75208, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

ULB Erasme Hospital

Brussels, Belgium

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3J4, Canada

Location

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, 500 082, India

Location

Policlinico A. Gemelli

Rome, 00168, Italy

Location

Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36208796 DERIVED

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Brian Vatcher
• Organization: Boston Scientific Corporation

brian.vatcher@bsci.com

+1-508-683-5274

Study Officials

• Jacques Deviere, MD, PhD

  ULB Erasme Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: June 16, 2016
• Study Start: January 25, 2017
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: November 21, 2022
• Results First Posted: November 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); CA (1); NL (1); US (6); IN (1); BE (1)