RecruitingPhase 3

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

Egypt44 participantsStarted 2025-03-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

✕. Age of less than18 years.
✕. 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

What they're measuring

The primary outcome that will be measured is the development of pancreatitis after the procedure according to consensus criteria

Timeframe: 24 hours

Trial details

NCT IDNCT06861010

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-20

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