Composite Index for Outcome Burden in Acute Cholangitis

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 80 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

514 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Study population

Study Population

• 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Asian Institute of Gastroenterology, India

Study start

Apr 20, 2026 Actual

Primary completion

Dec 31, 2026 Estimated

Study completion

Dec 31, 2026 Estimated

First posted

Jun 24, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts