Composite Index for Outcome Burden in Acute Cholangitis

NCT07667166 | Recruiting DMC

• 1 other identifier: AIG/IEC-Post BH&R 79/02.2026R1
• Study Type: observational
• Target: 514
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Cholangitis; Biliary Drainage

Keywords

Acute cholangitis; Biliary drainage; ERCP; PTBD; EUSBD; Composite outcome

Outcome Measures

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.

  30 days

Study Arms (1)

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

Procedure: Biliary drainage

Interventions

Biliary drainage PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead
• Christian Medical College, Vellore, India: collaborator
• Medanta, The Medicity, India: collaborator
• SIDS Hospital and Research Center, Surat: collaborator

Study Sites (1)

Asian Institute of Gastroenterology Pvt Ltd (AIG Hospitals)

Hyderabad, Telangana, 500032, India

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde; perfluoro-2,2,2',2'-tetramethyl-4,4'-bis(1,3-dioxolane)

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Hardik Hardik Rughwani

CONTACT

+919426928600; hardik.hr@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 24, 2026
• Study Start: April 20, 2026
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)