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

Common Bile Duct Stricture Clinical Trial

— NEOSTENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395013
• Other study ID #: 3196
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: Azienda Unità Sanitaria Locale della Romagna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3149
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Common Bile Duct Stricture
• Jaundice
• Jaundice; Malignant

Locations

Country	Name	City	State
Italy	Ospedale Morgagni-Pierantoni	Forlì	Forlì-Cesena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale della Romagna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of adverse events	Rate of periprocedural complications (i.e. bleeding, pancreatitis, cholecystitis) after biliary stent placement	From 2017 to 2021
Secondary	Rate of endoscopic reintervention	Rate of stent disfunction requiring an additional endoscopic procedure	From 2017 to 2021
Secondary	Rate of biliary cannulation and successful stent placement	Rate of biliary cannulation and successful stent placement	From 2017 to 2021