WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 Names:
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Outcome Measures
Primary Outcome Measures
- Pain Reduction [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.
- Rate of Related SAEs from WallFlex Pancreatic stent placement to end of study [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
- Stricture Resolution [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.
- Improved Clinical Status [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).
- Recurrence of Stricture [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.
- Stent Functionality [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.
- The Izbicki pain scale [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.
- Average Daily Narcotic Dose [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.
- Maintenance of VAS and Frequency of Pain Scores [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.
- Stent Placement Success [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.
- 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.]
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.
- Safety and Device Events [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 or older
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Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
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Chronic pancreatitis induced stricture of Cremer Type IV, namely distal dominant stricture with upstream ductal dilation.
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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.
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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.
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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.
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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.
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Minimum 5 mm diameter of dilated duct immediately upstream of pancreatic duct stricture
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Prior clearance of pancreatic stones where needed
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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.
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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.
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Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement as applicable.
Exclusion Criteria:
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Pancreatic or peri-ampullary cancer with or without pancreatic duct strictures caused by malignancy
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Biliary strictures caused by chronic pancreatitis that are symptomatic and/or in need of therapeutic intervention
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Perforated duct
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Ansa pancreatica
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Presence of pancreatic cysts suspected to be cystic tumor or requiring transmural drainage
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Duodenal/groove pancreatitis
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Autoimmune pancreatitis
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Pancreatic duct stenoses not located in the head of the pancreas
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Failed access during an attempted ERCP on a prior date at the investigational center
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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
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History of prior single pancreatic plastic stent(s) followed by a stent-free period shorter than 1 year before enrollment into the study
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History of prior side-by-side multiple pancreatic plastic stents up to one year prior to enrollment
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History of prior pancreatic metal stent(s)
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Reported recent history of acute relapsing pancreatitis in the absence of chronic pancreatitis
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Patients for whom endoscopic techniques are contraindicated
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Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado School of Medicine | Aurora | Colorado | United States | 80045 |
| 2 | Indiana University Health Medical Center | Indianapolis | Indiana | United States | 46202 |
| 3 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
| 4 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 5 | Methodist Dallas Medical Center | Dallas | Texas | United States | 75208 |
| 6 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 7 | ULB Erasme Hospital | Brussels | Belgium | ||
| 8 | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2X 3J4 |
| 9 | Asian Institute of Gastroenterology | Hyderabad | Andhra Pradesh | India | 500 082 |
| 10 | Policlinico A. Gemelli | Rome | Italy | 00168 | |
| 11 | Erasmus Medical Center | Rotterdam | Netherlands | 3015 CE |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Jacques Deviere, MD, PhD, ULB Erasme Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E7104