Clinical trial NCT05395013: Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)
Official title: Efficacy and Safety of Plastic, Covered and Uncovered Self-expandable Metal Stents in the Treatment of Malignant Biliary Obstructions (NEOSTENT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Common Bile Duct Stricture
Jaundice; Malignant
Keywords: Biliary Stent
Jaundice
Pancreatic cancer
Common bile duct cancer
Lead sponsor: Azienda Unità Sanitaria Locale della Romagna
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 3149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bilirubin decrease
timeFrame: From 2017 to 2021
Secondary outcomes:
measure: Rate of adverse events
timeFrame: From 2017 to 2021
measure: Rate of endoscopic reintervention
timeFrame: From 2017 to 2021
measure: Rate of biliary cannulation and successful stent placement
timeFrame: From 2017 to 2021
Other outcomes:
Locations:
city: Forlì
country: Italy
facility: Ospedale Morgagni-Pierantoni
state: Forlì-Cesena
Study officials:
References: