Back to resultsWallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures
Primary Purpose
Chronic Pancreatitis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pancreatic fully-covered self-expanding metal stent (FCSEMS)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pancreatitis
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
Sites / Locations
- University of Colorado School of Medicine
- Indiana University Health Medical Center
- University of Pittsburgh Medical Center
- Medical University of South Carolina
- Methodist Dallas Medical Center
- Virginia Mason Medical Center
- ULB Erasme Hospital
- Centre Hospitalier de l'Universite de Montreal
- Asian Institute of Gastroenterology
- Policlinico A. Gemelli
- Erasmus Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WallFlex FCSEMS Recipients
Arm 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.
Outcomes
Primary Outcome Measures
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.
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:
Pain managed by medication, with the exception of injectable narcotic use for more than 24 hours.
Pain not causing pancreatic FCSEMS removal.
Pain resolved by 72 hours after pancreatic FCSEMS placement.
Secondary Outcome Measures
Stent Placement Success
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.
Endoscopic Stent Removal Success
Endoscopic stent removal success is defined as ability to remove stent endoscopically (forceps, snare) without serious stent removal-related adverse events.
Stent Migration Rate
Stent migration is the change in location of a stent from its originally placed location. In this study, pancreatic stent migration was noted as partial or complete and either proximal (i.e., into the pancreas) or distal (i.e., out of the pancreas).
Restenting Rate
Restenting is the placement of a non-study stent due to no improvement in clinical status and associated persistence of stricture following removal or complete distal migration of the study stent.
Secondary Stricture Rate
A secondary stricture is a ductal narrowing located at the intraductal edge of the study stent.
Full Information
NCT ID
NCT02802020
First Posted
May 16, 2016
Last Updated
October 25, 2022
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02802020
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
November 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WallFlex FCSEMS Recipients
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Pancreatic fully-covered self-expanding metal stent (FCSEMS)
Other Intervention Name(s)
WallFlex
Intervention Description
The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.
Primary Outcome Measure Information:
Title
Pain Reduction
Description
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.
Time Frame
Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration
Title
Rate of Related SAEs From WallFlex Pancreatic Stent Placement to End of Study
Description
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:
Pain managed by medication, with the exception of injectable narcotic use for more than 24 hours.
Pain not causing pancreatic FCSEMS removal.
Pain resolved by 72 hours after pancreatic FCSEMS placement.
Time Frame
Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration
Secondary Outcome Measure Information:
Title
Stent Placement Success
Description
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.
Time Frame
Assessed upon study stent placement. This endpoint is assessed at the Study Stent Placement visit (Day 0).
Title
Endoscopic Stent Removal Success
Description
Endoscopic stent removal success is defined as ability to remove stent endoscopically (forceps, snare) without serious stent removal-related adverse events.
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.
Title
Stent Migration Rate
Description
Stent migration is the change in location of a stent from its originally placed location. In this study, pancreatic stent migration was noted as partial or complete and either proximal (i.e., into the pancreas) or distal (i.e., out of the pancreas).
Time Frame
Study stent placement through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration
Title
Restenting Rate
Description
Restenting is the placement of a non-study stent due to no improvement in clinical status and associated persistence of stricture following removal or complete distal migration of the study stent.
Time Frame
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
Title
Secondary Stricture Rate
Description
A secondary stricture is a ductal narrowing located at the intraductal edge of the study stent.
Time Frame
Study stent placement through 6 months post-stent removal or 6 months post-observation of complete or partial stent migration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Deviere, MD, PhD
Organizational Affiliation
ULB Erasme Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Indiana University Health Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
ULB Erasme Hospital
City
Brussels
Country
Belgium
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 082
Country
India
Facility Name
Policlinico A. Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures
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