Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)

Study Overview
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Brief Summary
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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.

Detailed Description
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Biliary drainage before surgery or chemotherapy is a common practice in patients with neoplastic stenosis of the common bile duct, often required by the presence of clinical conditions such as the onset of cholangitis or severe jaundice. 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.

Official Title
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Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)

Conditions
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Common Bile Duct Stricture, Jaundice; Malignant

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Common bile duct stricture (i.e. jaundice and/or cholangitis) of malignant origin Patients > 18 years old Obtaining informed consent Exclusion Criteria: - Lack of sufficient clinical and laboratory data to define clinical efficacy and/or follow-up available <1 month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilirubin decrease | Rate of resolution of obstructive jaundice in short and long term (i.e. maintenance of patency and/or the need for reintervention) of the different types of biliary stent placed in patients with neoplastic stenosis of the common bile duct | From 2017 to 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events | Rate of periprocedural complications (i.e. bleeding, pancreatitis, cholecystitis) after biliary stent placement | From 2017 to 2021 | 
| Rate of endoscopic reintervention | Rate of stent disfunction requiring an additional endoscopic procedure | From 2017 to 2021 | 
| Rate of biliary cannulation and successful stent placement | Rate of biliary cannulation and successful stent placement | From 2017 to 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary Stent, Jaundice, Pancreatic cancer, Common bile duct cancer