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OpenTrials
Completed

NCT Number: NCT05920954

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

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.

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Key information

Conditions

Acute Cholangitis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIG Hospitals

Hyderabad, Telangana, 500032, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERCP

Procedure

Repeat ERCP

Primary outcomes

  1. ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

    Time frame: 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.

  2. ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

    Time frame: Two Years

    PRIMARY OUTCOME: 30 day mortality

Secondary outcomes

  1. ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

    Time frame: Two Years

    • Organ failure.
    • In Hospital mortality.
    • Hospital stay.
    • Need for reintervention.
    • Need for readmission.

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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