Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Tanta University
44 participants
Mar 10, 2025
INTERVENTIONAL
Summary
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
Inclusion Criteria4
- 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
Exclusion Criteria8
- 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.
- Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
- Currently pregnant or nursing
- Admission due to established pancreatitis before ECRP
- Unwillingness to undergo ERCP.
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Interventions
Duloxetine, a non-opioid neuromodulator, has been widely used to manage neuropathic pain. It possesses dual central and peripheral analgesic properties
Placebo will have the same look and appearance of active comparator
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06860984