Chronic pancreatitis inflammation of the pancreas Pancreatitis
Conditions
Interventions
Patients will receive the WallFlex Pancreatic Stent, which will be placed in
the pancreatic duct during endoscopic retrograde cholangiopancreatography and
remain indwelling for up to 6 months.
Sponsors
Medische Hulpmiddelen Industrie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 induced stricture of Cremer Type IV, namely distal dominant stricture with upstream ductal dilation. 4. 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. 5. 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. 6. VAS Pain Score of 20 at the time of study stent placement for patients with no history of pancreatic stenting. VAS Pain Score of 20 at time of initial plastic pancreatic stent for patients with history of one prior plastic pancreatic stent indwelling for 3 months or less. VAS Pain Score is captured via Izbicki pain scale. 7. Pain occuring weekly or more frequently (assessed by Frequency of Pain sector of the Izbicki pain scale). 8. Minimum 5 mm diameter of dilated duct immediately upstream of pancreatic duct stricture 9. Prior clearance of pancreatic stones where needed * If pancreatic duct stone clearance prior to placement of the study stent includes ESWL, then a plastic stent should be placed immediately after the ESWL procedure instead and left indwelling 1-3 months. * 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. 10. Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement as applicable
Exclusion criteria
Exclusion criteria: 1. Pancreatic or peri-ampullary cancer with or without pancreatic duct strictures caused by malignancy 2. Biliary strictures caused by chronic pancreatitis 3. Perforated duct 4. Ansa pancreatica 5. Presence of pancreatic cysts suspected to be cystic tumor or requiring transmural drainage 6. Duodenal/groove pancreatitis 7. Pancreatic duct stenoses not located in the head of the pancreas 8. Failed access during an attempted ERCP on a prior date at the investigational center 9. History of prior side-by-side multiple pancreatic plastic and/or history of prior pancreatic metal stent(s) 10. Reported recent history of acute relapsing pancreatitis 11. Patients for whom endoscopic techniques are contraindicated. 12. Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor 13. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint is pain reduction at 6 months after removal of the WallFlex stent or 6 months after observation of migration of the stent. The primary safety endpoint is the rate of related serious adverse events from the placement of the WallFlex stent to the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include stricture resolution, clinical status improvement, recurrence of stricture, stent functionality, Izbicki pain score, average daily narcotic use, ability to deploy the stent in a satisfactory position, successful stent removal, and device event rate. | — |
Countries
Netherlands
Outcome results
None listed