RecruitingNot Applicable

Composite Index for Outcome Burden in Acute Cholangitis

India514 participantsStarted 2026-04-20

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage

Timeframe: 30 days

Trial details

NCT IDNCT07667166

SponsorAsian Institute of Gastroenterology, India

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-31

Contact for this trial

Hardik Hardik Rughwani

+919426928600 hardik.hr@gmail.com

View on ClinicalTrials.gov More Acute Cholangitis trials