WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures (NCT02802020) | Clinical Trial Compass
CompletedNot Applicable
WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures
United States67 participantsStarted 2017-01-25
Plain-language summary
To prospectively document the performance of a FCSEMS for treatment of pancreatic duct strictures in patients with painful chronic pancreatitis.
Who can participate
Age range18 Years
SexALL
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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 induced stricture of Cremer Type IV, namely distal dominant stricture with upstream ductal dilation.
* 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.
* 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.
* VAS Pain Score of ≥ 20 before study stent placement for patients without a prior plastic pancreatic stent. VAS Pain Score of ≥ 20 before initial plastic pancreatic stent placement for patients with a prior plastic pancreatic stent indwelling for 90 days or less before study stent placement. VAS Pain Score is captured via Izbicki pain scale.
* Pain occurring weekly or more frequently (assessed by Frequency of Pain sector of the Izbicki pain scale) as reported before study stent placement for patients without a prior plastic pancreatic stent, or before placement of initial plastic pancreatic stent for patients with a prior plastic pancreatic stent indwelling for 90 days or less before study stent placement.
* Minimum 5 mm diameter of dilated duct immediately upstream of pancreatic duct strictur…
What they're measuring
1
Pain Reduction
Timeframe: Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration
2
Rate of Related SAEs From WallFlex Pancreatic Stent Placement to End of Study
Timeframe: Baseline to 6 months post-stent removal or 6 months post-observation of complete or partial stent migration