The purpose of the study was to analyze the resolution rate of benign biliary strictures due
to chronic pancreatitis after temporary insertion of unflared-ends and flared-ends fully
covered self-expandable metal stents.
Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)
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Full eligibility criteria for NCT01457092
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
age ≥18 years,
symptomatic (persistent cholestasis, jaundice, cholangitis) common bile duct strictures secondary to CP, that persist 3 months or more after placement of a single 10 French plastic stent and
patient unfit for surgery (portal cavernomatosis, comorbidities) or patient refusal of surgery.
benign biliary strictures secondary to compression from a pancreatic pseudocyst;
patients with associated pancreatic neoplasia
ongoing alcohol abuse (ethanol > 80 g/day).
All locations for NCT01457092
View full eligibility
Tris trial is registered with FDA with number: NCT01457092. The sponsor of the trial is Catholic University of the Sacred Heart and it is looking for 17 volunteers for the current phase.
Official trial title: Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis Not Responding to Plastic Stenting: a Prospective Study With Two Years Follow-up.
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