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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
304
Repeat ERCP
AIG Hospitals
Hyderabad, Telangana, India
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.
Time frame: Two Years
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
PRIMARY OUTCOME: 30 day mortality
Time frame: Two Years
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
1. Organ failure. 2. In Hospital mortality. 3. Hospital stay. 4. Need for reintervention. 5. Need for readmission.
Time frame: Two Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.