About this trial
Endoscopic retrograde cholangiopancreatography (ERCP (, a key tool that is used in diagnosis and treatment of pancreato-biliary diseases. Post-ERCP pancreatitis (PEP) is the most common and serious complication that can occur following this procedure and can lead to significant morbidity and mortality. A variety of patient-related and procedure-related factors have been associated with higher rates of PEP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age more than 18 years old.
Gender: Males and Females
Patients with suitable indications for ERCP due to suspected pancreato-biliary disorders.
Blood amylase and lipase levels before ERCP are within the normal limits.
Disqualifiers
Age of less than18 years.
Uncontrolled diabetes mellitus (DM)
Severe bleeding tendency
Impaired renal function (serum creatinine > 2 mg/dL), (creatinine clearance <30 ml/min)
Trial design
Parallel
Treatments tested in this trial
Placebo
Other interventionPlacebo tablets will have the same look and appearance of ondansetron.
Ondansetron
Drugondansetron is commonly used as anti-emetics to prevent and treat chemotherapy-induced vomiting and nausea
Treatment groups
Trial outcomes
Primary outcomes
The primary outcome that will be measured is the development of pancreatitis after the procedure according to consensus criteria
The primary outcome that will be measured is the development of pancreatitis after the procedure according to consensus criteria. Briefly in this criteria PEP will be diagnosed if the Patient met two of the three following criteria after ERCP: new onset or increased abdominal pain consistent with acute pancreatitis, pancreatic enzyme elevation to at least 3 times the upper limit of normal at 24 hours after the procedure, and the necessity for new or continued hospitalization for at least 2 nights
Sponsors and contacts
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