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Clinical Trials in Egypt / NCT06861010
Recruiting Phase 3

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

NCT06861010 · tracked via the Priya Life Science Egypt tracker
Sponsor
Tanta University
Phase
Phase 3
Started
2025-03-01
Last updated
2026-03-13

Condition(s) studied

Pancreatic Diseases

Investigational drug(s) / intervention(s)

PlaceboOndansetron →

Placebo: Placebo tablets will have the same look and appearance of ondansetron.

Ondansetron: ondansetron is commonly used as anti-emetics to prevent and treat chemotherapy-induced vomiting and nausea

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The primary outcome that will be measured is the development of pancreatitis after the procedure according to consensus criteria — 24 hours
    The primary outcome that will be measured is the development of pancreatitis after the procedure according to consensus criteria. Briefly in this criteria PEP will be diagnosed if the Patient met two of the three following criteria after ERCP: new onset or increased abdominal pain consistent with acute pancreatitis, pancreatic enzyme elevation to at least 3 times the upper limit of normal at 24 hours after the procedure, and the necessity for new or continued hospitalization for at least 2 nights

Trial sites (1)

FacilityCityRegionStatus
Tanta Unuversity Tanta Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06861010 on ClinicalTrials.gov ↗ ← All trials in Egypt