Composite way to measure treatment success in acute cholangitis with biliary drainage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective observational study that develops and internally validates a composite outcome index to summarize overall treatment burden in patients with acute cholangitis undergoing biliary drainage (ERCP, PTBD, or EUS-BD). The index combines mortality, organ support, ICU use, complications, length of stay, and 30-day reinterventions/readmissions. Data are drawn from hospital records, with privacy protections in place, and no control group or predefined hypothesis is used. The study also explores how the index relates to illness severity and laboratory factors, and whether timing of drainage influences scores. The primary aim is to create a reliable tool that reflects the total burden of illness and recovery for this patient group.

Why it matters

Who can join: the full rules

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.

Where it's running

• Asian Institute of Gastroenterology Pvt Ltd (AIG Hospitals)
  Hyderabad, Telangana, India Recruiting

Study contacts

• Study coordinator: Hardik Hardik Rughwani
• Email: hardik.hr@gmail.com
• Phone: +919426928600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.