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New index aims to better measure bile duct infection treatment outcomes

NCT ID NCT07667166

Knowledge-focused Sponsor: Asian Institute of Gastroenterology, India Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This study looks at medical records of 514 adults in India with acute cholangitis (a bile duct infection and blockage) who had a drainage procedure. The goal is to create a new composite index that combines factors like death, need for organ support, ICU stay, complications, hospital stay, and readmission. This is an observational study, not testing a new treatment, and aims to improve how we measure treatment success.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give doctors a better tool to measure how well treatments work for acute cholangitis, potentially improving patient care.
What could go wrong
This is an observational study using past records, so it cannot prove cause and effect. The new index may not be better than existing measures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 514 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute cholangitis Biliary drainage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asian Institute of Gastroenterology Pvt Ltd (AIG Hospitals)

    RECRUITING

    Hyderabad, Telangana, 500032, India

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