NL-OMON45976
Withdrawn
Not Applicable
Fully Covered Self Expanding Metal Stents (FCSEMS) for Pancreatic Duct Strictures in Patients with Chronic Pancreatitis - WallFlex Pancreatic Pivotal
Medische Hulpmiddelen Industrie0 sites23 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic pancreatitis
- Sponsor
- Medische Hulpmiddelen Industrie
- Enrollment
- 23
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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
Outcomes
Primary Outcomes
Not specified
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