Health Condition 1: K861- Other chronic pancreatitis
Conditions
Interventions
Intervention1: Fully covered self-expanding metal stent (FCSEMS): The WallFlex Pancreatic FCSEMS consists of platinum-cored Nitinol wires wound together to form a cylinder, including a flare on the di
Sponsors
Boston Scientific
Eligibility
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 prior to PPS placement 4. Minimum 5mm diameter of dilated duct immediately upstream of pancreatic duct stricture prior to PPS placement 5. Availability of narcotic dosage for at least one month prior to PPS placement 6. Prior clearance of pancreatic stones where needed o If pancreatic duct stone clearance includes ESWL, then a single PPS may be placed immediately after the ESWL procedure at the discretion of the Investigator (e.g., if there is concern about fragments of stone sludge in the side branches of the pancreatic duct). NOTE: Per exclusion criterion #10, the indwell duration of a single PPS or the cumulative duration of consecutive, single PPS immediately prior to FCSEMS placement may not exceed 90 days. o If new pancreatic duct stones requiring ESWL have formed by the time of intended FCSEMS placement, then the patient will not receive the FCSEMS and be excluded from the study. Further treatment of the patient will be provided per standard of practice outside of the study. 7. History of documented pain relief during PPS indwell (assessed via Izbicki pain scale), defined as: o Severity of pain prior to PPS placement: VAS pain score >20 (assessed via Izbicki pain scale) o Frequency of pain prior to PPS placement: Several times a month or more frequently (assessed via Izbicki pain scale) o Pain relief during PPS indwell: Primary endpoint pain score (i.e., mean of the scores of the severity and frequency sectors of the Izbicki pain scale) after PPS placement 8. Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of FCSEMS 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 that are symptomatic and/or in need of therapeutic intervention 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. Autoimmune pancreatitis 8. Pancreatic duct stenoses not located in the head of the pancreas 9. Failed access during an attempted ERCP on a prior date at the investigational center 10. Duration of indwell of a single PPS or cumulative duration of consecutive single PPS immediately prior to FCSEMS placement exceeding 90 days 11. History of prior single PPS followed by a stent-free period shorter than 1 year before enrollment into the study 12. History of prior multiple side-by-side PPS up to one year prior to enrollment 13. Increase of average daily narcotic dose by =50% during single PPS indwell 14. History of prior pancreatic metal stent(s) 15. Reported recent history of acute relapsing pancreatitis in the absence of chronic pancreatitis 16. Patients for whom endoscopic techniques are contraindicated 17. Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor 18. 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 19. Women who are, or plan to become, pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY EFFECTIVENESS ENDPOINT Maintenance of pain relief 6 months after study stent removal or observation of complete distal migration (CDM) PRIMARY SAFETY ENDPOINT Rate of related serious adverse events (SAEs)Timepoint: Following the study device procedure, follow-up visits will occur at Month 1, Month 3, and Month 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Average daily narcotic dose for the prior monthTimepoint: Assessed at each study visit;Device deficienciesTimepoint: Study stent placement through end of study;Endoscopic study stent removal successTimepoint: Study stent removal;Izbicki pain scaleTimepoint: Assessed at each study visit;Stent functionalityTimepoint: Study stent placement until study stent removal or observation of complete or partial study stent migration;Stricture resolutionTimepoint: Time of study stent removal or observation of complete or partial study stent migration;Study stent placement successTimepoint: Study stent placement | — |
Countries
Belgium, India
Contacts
Public ContactMohan Ramchandani
Asian Institute of Gastroenterology
Outcome results
None listed