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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05920954

Enrollment

304

Registered

2023-06-27

Start date

2023-06-30

Completion date

2024-07-10

Last updated

2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cholangitis

Brief summary

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.

Interventions

PROCEDUREERCP

Repeat ERCP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization	Two Years	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.

Secondary

Measure	Time frame	Description
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization	Two Years	1. Organ failure. 2. In Hospital mortality. 3. Hospital stay. 4. Need for reintervention. 5. Need for readmission.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 22, 2026