Composite Index for Outcome Burden in Acute Cholangitis

NCT07667166 · tracked via the Priya Life Science India tracker

Sponsor

Asian Institute of Gastroenterology, India

Phase

Observational

Started

2026-04-20

Last updated

2026-08-31

Condition(s) studied

Acute CholangitisBiliary Drainage

Investigational drug(s) / intervention(s)

Biliary drainage

Biliary drainage: Underwent biliary drainage attempt (ERCP/PTBD/EUS-BD) or were planned for drainage (including failures with rescue drainage)

Study summary

The goal of this retrospective observational study is to construct a composite outcome to measure the success of treatment in patients who are presenting with acute cholangitis (blockage and infection of bile ducts) and undergoing a drainage procedure with different modalities. The study is not intended to test any predetermined hypothesis and does not have any comparison group. The participants' data are collated from retrospective hospital records and analysed for the purpose of the study. All the procedures are in place to ensure the confidentiality of the study participants while collating, analysing and sharing study findings.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage — 30 days
To derive a Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage, that integrates 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 and 30-day readmission.

Trial sites (1)

Facility	City	Region	Status
Asian Institute of Gastroenterology Pvt Ltd (AIG Hospitals)	Hyderabad	Telangana	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07667166 on ClinicalTrials.gov ↗ ← All trials in India