Composite Index for Outcome Burden in Acute Cholangitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAsian Institute of Gastroenterology, India
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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)
Trial 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.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Biliary drainage
Procedure/SurgeryUnderwent biliary drainage attempt (ERCP/PTBD/EUS-BD) or were planned for drainage (including failures with rescue drainage)
Treatment groups
514 Participants
are divided into 1 treatment groupGroup A: Patients with acute cholangitis meeting TG18 diagnostic criteria underwent biliary drainage attempt1 intervention
Trial outcomes
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 daysSponsors and contacts
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Asian Institute of Gastroenterology, India
Lead sponsor
Christian Medical College, Vellore, India
Collaborator
SIDS Hospital and Research Center, Surat
Collaborator
Medanta, The Medicity, India
Collaborator
Source ClinicalTrials.gov