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
Uncontrolled diabetes mellitus (DM)
Severe bleeding tendency
Impaired renal function (serum creatinine > 2 mg/dL), (creatinine clearance <30 ml/min)
Patients with severe heart disease.
Trial design
Parallel
Treatments tested in this trial
Duloxetine
DrugDuloxetine, a non-opioid neuromodulator, has been widely used to manage neuropathic pain. It possesses dual central and peripheral analgesic properties
Placebo capsule
Other interventionPlacebo will have the same look and appearance of active comparator
Treatment groups
Trial outcomes
Primary outcomes
The primary outcome that will be measured is the development of pancreatitis after the procedure
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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