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

NCT06860984

RecruitingPhase 3

Sponsor: Tanta University

Conditions: Biliary Disease

Interventions: Duloxetine, Placebo capsule

Countries: Egypt

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Tanta, Egypt