Composite Index for Outcome Burden in Acute Cholangitis

Study Aim To develop and internally validate a Composite Index that summarizes overall outcome burden in patients with acute cholangitis.

Primary Objective (Index Development)

• To derive a Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage, that inegrates

• Mortality (30-day and in-hospital)
• Organ support,
• ICU admission and ICU length of stay,
• Complication burden and severity (AGREE and Clavien-Dindo classification as applicable),
• Hospital length of stay,
• 30-day reintervention
• 30-day readmission.

Secondary Objectives

• To evaluate the association of the Composite Index with:

• TG18 severity grade (I vs II vs III),
• Baseline physiological/lab derangement (WBC, bilirubin, creatinine, lactate),
• To explore whether timing of biliary drainage is associated with composite index scores (exploratory-hypothesis-generating).

Inclusion criteria

• Age 18 to 80 years
• Hospital admission with definite diagnosis of acute cholangitis meeting TG18 diagnostic criteria
• TG18 Grade I (Mild) Grade II (moderate) or Grade III (severe) at presentation/admission or prior to drainage.
• Underwent biliary drainage attempt (ERCP/PTBD/EUS-BD) or were planned for drainage (including failures with rescue drainage).
• First episode of index BD in case of patients undergoing multiple episodes of index BD as per operational definitions (Technical supplement 1)
• Planned repeat BD in same admission shall be considered as continuation of the index BD and all the procedural details shall be documented and analysed.

Exclusion criteria

• Pregnant women
• Missing key outcome data (minimum required: mortality status + ICU admission status + Length of stay)
• Non-biliary sepsis without evidence of biliary obstruction/infection on review.
• A patients with past history of BD outside the study setting (As this is akin to second episode of Index BD)
• Subsequent episodes of Index BD (other than the first index BD episode) among patients with more than one episode of Index BD.