NCT05395013

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,149 (actual)
• Sponsor: Azienda Unità Sanitaria Locale della Romagna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Common Bile Duct Stricture
• Jaundice; Malignant

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2022-05-27
• Last updated: 2022-06-07

Locations

1 site across 1 country: Italy