Actively Recruiting
Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Led by Tanta University · Updated on 2026-03-13
44
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ondansetron in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), a common and serious complication after ERCP. This randomized, double-blind Phase 3 study focuses on adults aged 18 to 65 who require ERCP for suspected pancreato-biliary diseases. The study is sponsored by Tanta University and aims to reduce morbidity and mortality associated with PEP by investigating patient and procedure-related factors influencing its occurrence. Participants will be randomly assigned to receive either ondansetron or a placebo tablet two hours before undergoing ERCP. The placebo tablets look identical to the ondansetron tablets to maintain blinding. This setup allows the study to compare the effects of ondansetron against no active medication in preventing pancreatitis after the procedure. During the study, researchers will carefully monitor participants for the development of pancreatitis within 24 hours after ERCP, using established consensus criteria. Participants' blood amylase and lipase levels will be checked before the procedure to ensure normal levels. The study involves close observation of safety and treatment outcomes, with the overall participation lasting through the procedure and the immediate 24-hour follow-up period for primary outcome assessment.
CONDITIONS
Brief Title
Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age more than 18 years old
- Both 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
You will not qualify if you...
- Age less than 18 years
- Uncontrolled diabetes mellitus
- Severe bleeding tendency
- Impaired renal function (serum creatinine > 2 mg/dL or creatinine clearance < 30 ml/min)
- Severe heart disease
- Prior biliary or pancreatic sphincterotomy, dilatation, or stenting
- Currently pregnant or nursing
- Admission due to established pancreatitis before ERCP
- Unwillingness to undergo ERCP
- Previously documented allergy to ondansetron
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of the ERCP procedure
Participants receive either ondansetron or placebo tablets 2 hours before the endoscopic retrograde cholangiopancreatography (ERCP) procedure to prevent post-ERCP pancreatitis.
1 treatment visit (in-person)
Duration - 24 hours after the procedure
Participants are monitored for the development of pancreatitis and other outcomes after the ERCP procedure.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Tanta Unuversity
Tanta, Egypt, 31527
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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