Developing and Validating a Composite Outcome Measure for Patients with Acute Cholangitis Undergoing Biliary Drainage in a Multicenter Retrospective Study

What this Trial Is About

This research aims to develop and validate a Composite Index to measure the overall outcome burden in patients with acute cholangitis who undergo biliary drainage procedures. The study focuses on integrating various important factors such as mortality, organ support, ICU admission and length of stay, complication severity, hospital length of stay, and 30-day reintervention and readmission rates. It is a retrospective observational study using hospital records without a comparison group. Participants in the study are patients diagnosed with acute cholangitis who underwent or were planned for biliary drainage through procedures like ERCP, PTBD, or EUS-BD. The study includes patients with different severity grades TG18 Grades I, II, and III and collects detailed procedural data including planned repeat drainage within the same admission. During the study, researchers analyze retrospective hospital data to construct and internally validate the composite outcome index. They examine associations with disease severity and baseline lab values, and explore timing of biliary drainage in relation to outcomes. Confidentiality measures are in place while collating and sharing findings. The primary outcome is the multidimensional composite index measured over 30 days after drainage.

Composite Index for Outcome Burden in Acute Cholangitis