Using Ondansetron to Prevent Pancreatitis After ERCP
Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
This study is testing if the medication ondansetron can help prevent pancreatitis in adults who are having an ERCP procedure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT06861010 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of ondansetron in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, a common complication that can lead to significant health issues. The study involves administering either ondansetron or a placebo to patients undergoing ERCP for suspected pancreato-biliary disorders. Participants will be monitored for the occurrence of pancreatitis following the procedure, with the aim of determining if ondansetron can effectively reduce this risk. The trial is designed for patients over 18 years old who meet specific health criteria.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with indications for ERCP due to suspected pancreato-biliary disorders and normal blood amylase and lipase levels.
Not a fit: Patients with uncontrolled diabetes, severe heart disease, or those who have previously had certain biliary procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of pancreatitis following ERCP, improving patient outcomes and safety.
How similar studies have performed: While the specific use of ondansetron for this purpose may be novel, similar studies have explored the prevention of post-ERCP pancreatitis with varying results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tanta
- Tanta Unuversity — Tanta, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.