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RecruitingNCT07667166CHOLINDEX-01Updated Nov 10, 2026

Composite Index for Outcome Burden in Acute Cholangitis

An observational study in Acute Cholangitis and Biliary Drainage, sponsored by Asian Institute of Gastroenterology, India. Recruiting at 1 site in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Asian Institute of Gastroenterology, India · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Nov 10, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
514
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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)

1. 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

  1. 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),
  2. To explore whether timing of biliary drainage is associated with composite index scores (exploratory-hypothesis-generating).
02

Conditions studied

  • Acute Cholangitis
  • Biliary Drainage

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Keywords

  • Acute cholangitis
  • Biliary drainage
  • ERCP
  • PTBD
  • EUSBD
  • Composite outcome
03

In context

Cholangitis

82 studies on the registry are indexed under Cholangitis; 17 are open to participants now.

This study's planned enrollment of 514 is above the median of 250 across 27 observational studies indexed under Cholangitis.

Browse Cholangitis studies →

Lead sponsor

Asian Institute of Gastroenterology, India is the lead sponsor of 135 studies on the registry; 59 are open to participants now.

Browse Asian Institute of Gastroenterology, India studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
514 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with acute cholangitis meeting TG18 diagnostic criteria underwent biliary drainage attempt

    Procedure: Biliary drainage

Interventions

  • ProcedureBiliary drainage

    Underwent biliary drainage attempt (ERCP/PTBD/EUS-BD) or were planned for drainage (including failures with rescue drainage)

    Also known as: ERCP, PTBD, EUS BD

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Asian Institute of Gastroenterology Pvt Ltd (AIG Hospitals)
    Hyderabad, Telangana 500032, India
    Recruiting
    • Hardik Rughwani · Contacthardik.hr@gmail.com · +919426928600
    • Hardik Rughwani · Principal investigator
    • Dr.Duvvur Nageshwar Reddy · Sub investigator
    • Nitin Jagtap · Sub investigator
08

References and documents

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.

Related links

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Aug 31, 2026→Dec 31, 2026
Nov 10, 2026
Study completion
Aug 31, 2026→Dec 31, 2026
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Primary completion Aug 31, 2026→Dec 31, 2026
    Study completion Aug 31, 2026→Dec 31, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07667166
Lead sponsor
Asian Institute of Gastroenterology, India
Collaborators
Christian Medical College, Vellore, India, SIDS Hospital and Research Center, Surat, Medanta, The Medicity, India
Responsible party
Hardik Rughwani (Consultant Gastroenterologist, Asian Institute of Gastroenterology, India) — Principal investigator
First posted
Jun 24, 2026
Start date
Apr 20, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 10, 2026

Study contacts

Hardik Hardik Rughwani
Contact
hardik.hr@gmail.com
+919426928600

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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