Common Bile Duct Stricture, Jaundice; Malignant
Conditions
Keywords
Biliary Stent, Jaundice, Pancreatic cancer, Common bile duct cancer
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.
Interventions
None listed
Sponsors
Azienda Unità Sanitaria Locale della Romagna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Rate of biliary cannulation and successful stent placement | From 2017 to 2021 | Rate of biliary cannulation and successful stent placement |
Countries
Italy
Outcome results
None listed