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

Completed

• Conditions: Common Bile Duct Stricture; Jaundice; Malignant

• Registration Number: NCT05395013
• Lead Sponsor: Azienda Unità Sanitaria Locale della Romagna

Brief Summary

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

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 Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-13
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-04
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3149

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bilirubin decrease	From 2017 to 2021	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ospedale Morgagni-Pierantoni; 🇮🇹 Forlì, Forlì-Cesena, Italy