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

NCT05920954 | Completed

• 1 other identifier: Urgent ERCP vs Early ERCP
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholangitis

Outcome Measures

Primary Outcomes (2)

• ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

  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

  PRIMARY OUTCOME: 30 day mortality

  Two Years

Secondary Outcomes (1)

• ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization

  Two Years

Study Arms (2)

Urgent ERCP

EXPERIMENTAL

Urgent ERCP (\<24 Hours).

Procedure: ERCP

Early ERCP

EXPERIMENTAL

Early ERCP(24 to 48 Hours).

Procedure: ERCP

Interventions

ERCP PROCEDURE

Repeat ERCP

Early ERCP; Urgent ERCP

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who met criteria for a definite diagnosis acute cholangitis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

AIG Hospitals

Hyderabad, Telangana, 500032, India

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 27, 2023
• Study Start: June 30, 2023
• Primary Completion: June 10, 2024
• Study Completion: July 10, 2024
• Last Updated: October 2, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)