Cholangitis Clinical Trial
Official title:
Antibiotic Prophylaxis for ERCP: a Comparison of Intravenous Ceftriaxone With Intravenous Moxifloxacin in the Prophylaxis of Cholangitis
Background and aims: The use of prophylactic antibiotics before endoscopic retrograde
cholangiopancreatography (ERCP) is recommended by all major international
gastroenterological societies, especially in the presence of an obstructed biliary system.
Their use is intended to decrease or eliminate the incidence of complications following the
procedure, namely cholangitis, cholecystitis, septicemia, and pancreatitis. However, there
were a few reports concerning the dosage, duration and adopting antibiotics most suitable
for this purpose. The aim of this prospective comparative study is to compare the occurrence
rate of post-procedural complications, such as cholangitis, bacteremia and septicemia
between intravenous moxifloxacin and ceftriaxone for the prophylactic use in patients with
bile duct obstruction who will undergo therapeutic ERCP procedure.
Methods: In this prospective study, a total of 160 patients (calculated by IBM SPSS Sample
Power, version 3.0) with bile duct obstruction due to variable causes (bile duct stones,
benign or malignant stricture, etc) will be enrolled and randomly allocated to intravenous
moxifloxacin and ceftriaxone group, respectively (using simple randomization program).
Intravenous moxifloxacin (400 mg/day, infused more than 60 min) or ceftriaxone (2 g/day,
diluted in 40 cc of 5% dextrose water, infused more than 30 min) will be given 90 minutes
before ERCP procedure, and will be given to a patient for more than 3 days if the patient
develops symptoms and signs of cholangitis or septicemia.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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