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

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.

Study Overview

• Status: Completed
• Conditions: Common Bile Duct Stricture; Jaundice; Malignant

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 3149

Contacts and Locations

Study Locations

• Italy
  • Forlì-Cesena
    • Forlì, Forlì-Cesena, Italy
      • Ospedale Morgagni-Pierantoni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with common bile duct stricture (i.e. jaundice and/or cholangitis) of malignant origin who underwent endoscopic drainage

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Unità Sanitaria Locale della Romagna

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2021
• Primary Completion (ACTUAL): May 31, 2022
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: November 13, 2021
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (ACTUAL): May 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 4, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Pancreatic cancer; Jaundice; Biliary Stent; Common bile duct cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Hyperbilirubinemia; Jaundice
• Other Study ID Numbers: 3196

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No