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

Tanta University

Status and phase

Enrolling

Phase 3

Conditions

Biliary Disease

Treatments

Drug: Duloxetine

Other: Placebo capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT06860984

5487

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.