Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis

Study Overview
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Brief Summary
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Acute Cholangitis is an emergency associated with significant morbidity and mortality which require prompt recognition and treatment. The decompression of biliary tree along with antibiotics are mainstay of therapy. Randomized comparative studies showed that ERCP achieves biliary decompression with markedly less morbidity and mortality compared with surgery, regardless of clinical drainage. Percutaneous trans hepatic drainage (PTBD) can be alternative to endoscopic drainage in selected group especially advanced hilar strictures and patients who are unfit for endoscopic procedure. Recent ASGE guidelines suggested the performance of ERCP within 48 hours for patients with acute cholangitis; however it is conditional recommendation with very low quality of evidence. Till date, no randomized trial has compared urgent ERCP versus early ERCP for acute cholangitis.

Official Title
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Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis

Conditions
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Acute Cholangitis

Intervention / Treatment
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* Procedure: ERCP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who met criteria for a definite diagnosis acute cholangitis. Exclusion Criteria: Patients with severe acute cholangitis at admission. Age < 18 years. Pregnancy. Associated Acute Severe Pancreatitis. Patients with suspected high grade (Bismuth III/IV) biliary stricture in whom PTBD is considered as primary method of biliary drainage. Not giving consent.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urgent ERCP<br>Urgent ERCP (<24 Hours). | Procedure: ERCP<br>* Repeat ERCP<br>|
| Experimental: Early ERCP<br>Early ERCP(24 to 48 Hours). | Procedure: ERCP<br>* Repeat ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization | To perform a single-centre, randomized trial comparing the efficacy (the ability to produce a desired or intended result) of urgent versus early ERCP (Endoscopic retrograde cholangiopancreatography) for reducing the risk of 30 days of mortality. | Two Years | 
| ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization | PRIMARY OUTCOME: 30 day mortality | Two Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization | Organ failure. In Hospital mortality. Hospital stay. Need for reintervention. Need for readmission. | Two Years |