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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Internal Validation of a Multidimensional Composite Index for Outcome Burden in Acute Cholangitis: A Multicentre Retrospective Cohort Study in India
- ClinicalTrials.gov ID
- NCT07667166
- Acronym / sponsor ID
- CHOLINDEX-01 / AIG/IEC-Post BH&R 79/02.2026R1
- Conditions
- Acute Cholangitis, Biliary Drainage
- Keywords
- Acute cholangitis, Biliary drainage, ERCP, PTBD, EUSBD, Composite outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 514 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, SIDS Hospital and Research Center, Surat, Medanta, The Medicity, India
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute cholangitis meeting TG18 diagnostic criteria underwent biliary drainage attempt | – | Procedure: Biliary drainage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biliary drainageAlso: ERCP, PTBD, EUS BDUnderwent biliary drainage attempt (ERCP/PTBD/EUS-BD) or were planned for drainage (including failures with rescue drainage) | Procedure or surgery | Patients with acute cholangitis meeting TG18 diagnostic criteria underwent biliary drainage attempt |
Primary outcome
Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage
Time frame: 30 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- BackgroundTG18/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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholangitis and Biliary Drainage, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hardik Hardik Rughwani (+919426928600, hardik.hr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07667166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.