Pancreatic Metal Stents in Chronic Pancreatitis

Study Overview
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Brief Summary
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The purpose of this study is to document the performance of a new Fully Covered Self Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis.

Detailed Description
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This study is a prospective, single arm, pre-approval study. Treatment of 10 patients will take place at 1-3 clinical centers in two phases. Phase 1 will include treatment of five patients with a three month stent indwell period at one clinical center. Phase 2 will include treatment of five additional patients with a 3-6 month stent indwell period at 1-3 clinical centers. Expected duration of participation for each patient is approximately 27 months for Phase 1 and approximately 27-30 months for Phase 2. All patients, regardless of phase, will be followed for 24 months after stent removal. Post-removal follow-up visits will occur at 1, 3, 6, 12, 18 and 24 months.

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

Conditions
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Refractory Pancreatic Duct Strictures, Painful Chronic Pancreatitis

Intervention / Treatment
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* Device: WallFlex Pancreatic Stent


Participation Criteria
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Eligibility Criteria
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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 of Cremer Type IV (Segmental pancreatitis of the head of the pancreas). See Appendix for Cremer classifications. Improvement of pancreatic pain during previous placement of a single pancreatic plastic stent At least one of the following: Abdominal pain most probably related to chronic pancreatitis Recurrent dominant main pancreatic duct stricture in the head of the pancreas after prior indwell of pancreatic plastic stent(s) if pain score was available prior to preceding stent therapy. Recurrent stricture to be visually assessed at endoscopy and confirmed by recurrent main pancreatic duct dilatation at MRCP. Relapsing pain due to pancreatic duct stent blockage (with only one stent in place) Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement with informed patient consent. Exclusion Criteria: Strictures caused by malignancies Biliary strictures caused by chronic pancreatitis Perforated duct. Ansa pancreatica or H anatomy Pancreatic duct stenoses not located in the head of the pancreas Failed access during an attempted ERCP on a prior date Prior pancreatic metal stent(s) Concurrent ESWL (Extracorporeal Shock Wave Lithotripsy) during the same treatment session 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 subject living at such a distance from the investigational center that

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FCSEMS<br>Patients will receive the WallFlex Pancreatic Stent. | Device: WallFlex Pancreatic Stent<br>* Temporary placement of the WallFlex Pancreatic Stent for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis. Stent will be removed after 3-6 months indwell.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis | Clinical success defined as decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis 3 months after stent removal compared to baseline prior to stent indwell period. | 3 months after study stent removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and severity of serious adverse events related to the stenting procedure, to the indwelling stent and/or to stent removal |  | Duration of study participation, an average of 27-30 months | 
| Stent placement success | Ability to deploy the stent in satisfactory position (Stent Placement Success). Satisfactory position is defined as the stent being across the stricture, without visible impaction at an angle and distal end visible into the duodenum. | Study Stent Placement Procedure | 
| Type of additional intervention within pancreatic duct |  | Duration of study participation, an average of 27-30 months | 
| Stent removal success | Successful stent removal (Stent Removal Success) defined as ability to remove stent endoscopically (grasper, snare, stent-in-stent) without serious stent removal-related adverse events | Study Stent Removal | 
| Change of pain medication intake | Change of pain medication intake (type of medication) from baseline to each follow-up visit. | Duration of study participation, an average of 27-30 months | 
| Number of device events | Device Events, including findings not associated with adverse events, such as but not limited to asymptomatic stent migration. | Duration of study participation, an average of 27-30 months | 
| Stricture resolution of pancreatic duct after stent removal | Assessment of pancreatic duct after stent removal compared to baseline, including ERCP to document extent of stricture resolution, extent of resolution of ductal dilation above the treated dominant stricture, and presence or absence of secondary ductal strictures at the level of where the proximal edge of the stent was located | Study Stent Removal | 
| For patients who proceed to surgery, impact of prior SEMS on surgical outcomes. |  | Up to surgery | 
| Stent functionality | Stent functionality: Relief of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis at 3 days, 2 weeks, 1 month, 2 months, 4 months (Phase 2 patients as applicable) and just prior to stent removal compared to baseline prior to stent placement, using established pancreatic pain score | Up to time of study stent removal,average of 3-6 months on study | 
| Stricture Resolution at stent removal | Stricture Resolution at stent removal, defined as pancreatographic confirmation of drainage of injected contrast medium after stent removal without visible persistent stricture | Study Stent Removal | 
| Time to Recurrence of Stricture | Time to Recurrence of Stricture, established in patients who had stricture resolution at stent removal and defined as time elapsed from stent removal till recurrence of pain with associated documentation of narrowing of pancreatic duct. Recurrence of stricture will be documented at the time it is identified and absence of stricture recurrence will be ascertained at 1, 3, 6, 12, 18 and 24 months after stent removal. Pain will be documented using an established pancreatic pain score. | Duration of study participation, an average of 27-30 months | 
| Reason for additional intervention within pancreatic duct |  | Duration of study participation, an average of 27-30 months | 
| Timing of additional intervention within pancreatic duct |  | Duration of study participation, an average of 27-30 months |