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

Tanta University

Status and phase: Enrolling; Phase 3

Conditions: Pancreatic Diseases

Treatments: Drug: Ondansetron; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06861010

54782

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

1. Age more than 18 years old.
2. Gender: Males and Females
3. Patients with suitable indications for ERCP due to suspected pancreato-biliary disorders.
4. Blood amylase and lipase levels before ERCP are within the normal limits.

Exclusion criteria

1. Age of less than18 years.
2. Uncontrolled diabetes mellitus (DM)
3. Severe bleeding tendency
4. Impaired renal function (serum creatinine > 2 mg/dL), (creatinine clearance <30 ml/min)
5. Patients with severe heart disease.
6. Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
7. Currently pregnant or nursing
8. Admission due to established pancreatitis before ECRP
9. Unwillingness to undergo ERCP.
10. Previously documented allergy to ondansetron.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

the patients will receive placebo tablet 2 h before ERCP

Treatment:

Other: Placebo

ondansetron group

Active Comparator group

Description:

the patients will receive placebo tablet 2 h before ERCP.

Treatment:

Drug: Ondansetron