Acute CholangitisCHOLINDEX-01NCT07667166
Composite Index for Outcome Burden in Acute Cholangitis
An observational study of Acute Cholangitis and Biliary Drainage, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Cholangitis, Biliary Drainage
- What is being tested?
- Biliary drainage
- Type of treatment
- Surgery or procedure
- How many people
- 514 participants
- Where
- 1 siteIndia
- Study dates
- 20 Apr 2026to 31 Aug 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology Pvt Ltd (AIG Hospitals)
Hyderabad, Telangana, 500032
Hardik Rughwani, +919426928600, hardik.hr@gmail.com
Hardik Rughwani
About this study
Official title: Development and Internal Validation of a Multidimensional Composite Index for Outcome Burden in Acute Cholangitis: A Multicentre Retrospective Cohort Study in India
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.
Read the detailed description
Study Aim To develop and internally validate a Composite Index that summarizes overall outcome burden in patients with acute cholangitis.
Primary Objective (Index Development)
- To derive a Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage, that inegrates
- 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
- 30-day readmission.
Secondary Objectives
- To evaluate the association of the Composite Index with:
- TG18 severity grade (I vs II vs III),
- Baseline physiological/lab derangement (WBC, bilirubin, creatinine, lactate),
- To explore whether timing of biliary drainage is associated with composite index scores (exploratory-hypothesis-generating).
- Conditions
- Acute Cholangitis, Biliary Drainage
- Being tested
- Biliary drainage
- Keywords
- Acute cholangitis, Biliary drainage, ERCP, PTBD, EUSBD, Composite outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary drainageProcedure or surgery
Also called ERCP, PTBD, EUS BD
Underwent biliary drainage attempt (ERCP/PTBD/EUS-BD) or were planned for drainage (including failures with rescue drainage)
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute cholangitis meeting TG18 diagnostic criteria underwent biliary drainage attempt | Not described Receives: Procedure: Biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start20 Apr 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 514 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, SIDS Hospital and Research Center, Surat, Medanta, The Medicity, India
- Responsible party
- Principal investigator, Hardik Rughwani, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667166
- Sponsor's protocol ID
- AIG/IEC-Post BH&R 79/02.2026R1
- Acronym
- CHOLINDEX-01
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
TG18/TG13 Diagnostic & Severity Criteria: Kiriyama S et al. J Hepatobiliary Pancreat Sci 2018;25:17-30. ASGE Guideline on Cholangitis Management: Buxbaum JL et al. Gastrointest Endosc 2021;94:207-221. TG18 Biliary Drainage: Mukai S et al. J Hepatobiliary Pancreat Sci 2017;24:537-549. TOKYO Criteria 2014: Isayama H et al. Dig Endosc 2015;27:259-264. TOKYO Criteria 2024: Isayama H et al. Dig Endosc 2024;36:1393-1413. Khashab MA et al. Clin Gastroenterol Hepatol 2012;10:1157-1161.