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RECRUITING Phase 3 ClinicalTrials.gov

Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Sponsor: Tanta University • ClinicalTrials.gov ID: NCT06860984

Registry updated: 2026-08-18
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Description

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.

Interventions

  • Duloxetine (Drug)
    Duloxetine, a non-opioid neuromodulator, has been widely used to manage neuropathic pain. It possesses dual central and peripheral analgesic properties
  • Placebo capsule (Other)
    Placebo will have the same look and appearance of active comparator

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Conditions

Biliary Disease

Locations

  • Tanta Unuversity — Tanta, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record