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

July 26, 2023 updated by: Asian Institute of Gastroenterology, India

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

296

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500032
        • Recruiting
        • AIG Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
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.
Two Years
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
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
Time Frame: Two Years
  1. Organ failure.
  2. In Hospital mortality.
  3. Hospital stay.
  4. Need for reintervention.
  5. Need for readmission.
Two Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2023

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 25, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Urgent ERCP vs Early ERCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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