Pancreatic Metal Stents in Chronic Pancreatitis

Boston Scientific Corporation10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Refractory Pancreatic Duct Strictures Painful Chronic Pancreatitis

Interventions

WallFlex Pancreatic StentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 or older 2. Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study 3. Chronic pancreatitis of Cremer Type IV (Segmental pancreatitis of the head of the pancreas). See Appendix for Cremer classifications. 4. Improvement of pancreatic pain during previous placement of a single pancreatic plastic stent 5. 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) 6. Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement with informed patient consent. Exclusion Criteria: 1. Strictures caused by malignancies 2. Biliary strictures caused by chronic pancreatitis 3. Perforated duct. 4. Ansa pancreatica or H anatomy 5. Pancreatic duct stenoses not located in the head of the pancreas 6. Failed access during an attempted ERCP on a prior date 7. Prior pancreatic metal stent(s) 8. Concurrent ESWL (Extracorporeal Shock Wave Lithotripsy) during the same treatment session 9. Patients for whom endoscopic techniques are contraindicated. 10. Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor 11. Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational center that

Locations (1)

ULB Erasme Hospital

Brussels, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 3 months after study stent removal

Secondary Outcomes

Occurrence and severity of serious adverse events related to the stenting procedure, to the indwelling stent and/or to stent removal

Time frame: 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.

Time frame: Study Stent Placement Procedure

Type of additional intervention within pancreatic duct

Time frame: 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

Time frame: Study Stent Removal

Change of pain medication intake

Change of pain medication intake (type of medication) from baseline to each follow-up visit.

Time frame: Duration of study participation, an average of 27-30 months

Number of device events

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.