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

Sponsor

Asian Institute of Gastroenterology, India (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05920954

Collaborator

(none)

296

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cholangitis	Procedure: ERCP	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

296 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 13, 2023

Anticipated Primary Completion Date :

Mar 13, 2025

Anticipated Study Completion Date :

Mar 13, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization [Two Years]
PRIMARY OUTCOME: 30 day mortality

Secondary Outcome Measures

ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization [Two Years]
Organ failure. In Hospital mortality. Hospital stay. Need for reintervention. Need for readmission.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Asian Institute of Gastroenterology, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asian Institute of Gastroenterology, India

ClinicalTrials.gov Identifier:

NCT05920954

Other Study ID Numbers:

Urgent ERCP vs Early ERCP

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cholangitis

Study Results

No Results Posted as of Jun 27, 2023