RecruitingPhase 3NCT06860984

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


Sponsor

Tanta University

Enrollment

44 participants

Start Date

Mar 10, 2025

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

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

DRUGDuloxetine

Duloxetine, a non-opioid neuromodulator, has been widely used to manage neuropathic pain. It possesses dual central and peripheral analgesic properties

OTHERPlacebo capsule

Placebo will have the same look and appearance of active comparator


Locations(1)

Tanta Unuversity

Tanta, Egypt

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NCT06860984