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

Acute Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920954
• Other study ID #: Urgent ERCP vs Early ERCP
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: March 15, 2025

Study information

• Verified date: July 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: Hardik Rughwani, MD, DM
• Phone: 9426928600
• Email: hardik.hr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Cholangitis
• Cholangitis

Intervention

Procedure:
• ERCP
Repeat ERCP

Locations

Country	Name	City	State
India	AIG Hospitals	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization	Organ failure.; In Hospital mortality.; Hospital stay.; Need for reintervention.; Need for readmission.	Two Years