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

Not Applicable

Recruiting

• Conditions: Acute Cholangitis
• Interventions: Procedure: ERCP

• Registration Number: NCT05920954
• Lead Sponsor: Asian Institute of Gastroenterology, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-06-25
• Study First Posted: 2023-06-27
• Study Start: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 296

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early ERCP	ERCP	Early ERCP(24 to 48 Hours).
Urgent ERCP	ERCP	Urgent ERCP (\<24 Hours).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

AIG Hospitals; 🇮🇳 Hyderabad, Telangana, India