Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)
NCT ID: NCT05395013
Last Updated: 2022-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3149 participants
OBSERVATIONAL
2021-11-01
2022-05-31
Brief Summary
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Detailed Description
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The endoscopic approach has now been identified by the literature as the preferential drainage route, due to a lower incidence of adverse effects, liver or intraperitoneal metastases and lower costs associated with this technique compared to percutaneous drainage.
The latest guidelines from the European Society of Gastrointestinal Endoscopy recommend the placement of a 10 mm diameter self-expandable metal stent (SEMS) as the first choice for endoscopic drainage in patients with extra-hepatic biliary stenosis of neoplastic origin. Compared to plastic stents, SEMS placement is associated with a lower risk of developing stent dysfunction and/or cholangitis, lower risk of reintervention, and better patient survival.
However, among the various types of metal stents available, to date there is no agreement on which type is the most suitable, as data on efficacy and post-interventional morbidity and mortality of the fully or partially covered and uncovered metal stents are contradictory.
The aim of the study is to evaluate the efficacy and safety of the various types of stents available for biliary drainage in patients with neoplastic stenosis of the common bile duct and to evaluate the adherence to the current guidelines available.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients \> 18 years old
* Obtaining informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Azienda Unità Sanitaria Locale della Romagna
OTHER
Responsible Party
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Carlo Fabbri
Chief of Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals
Locations
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Ospedale Morgagni-Pierantoni
Forlì, Forlì-Cesena, Italy
Countries
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Other Identifiers
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3196
Identifier Type: -
Identifier Source: org_study_id
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