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

Asian Institute of Gastroenterology, India

Status: Enrolling

Conditions: Acute Cholangitis

Treatments: Procedure: ERCP

Study type: Interventional

Funder types: Other

Identifiers

NCT05920954

Urgent ERCP vs Early ERCP

Details and patient eligibility

About

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.

Enrollment: 296 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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296 participants in 2 patient groups

Urgent ERCP

Experimental group

Description:

Urgent ERCP (\<24 Hours).

Treatment:

Procedure: ERCP

Early ERCP

Experimental group

Description:

Early ERCP(24 to 48 Hours).

Treatment:

Procedure: ERCP