Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Ondansetron.
- Who it may be relevant to
- Registry conditions: Pancreatic Diseases. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Placebo
Placebo tablets will have the same look and appearance of ondansetron. - Drug Ondansetron
ondansetron is commonly used as anti-emetics to prevent and treat chemotherapy-induced vomiting and nausea
Primary outcome measures
- The primary outcome that will be measured is the development of pancreatitis after the procedure according to consensus criteria [Time frame: 24 hours]
Eligibility criteria
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
- Unwillingness to undergo ERCP.
- Previously documented allergy to ondansetron.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta Unuversity — Tanta
Identifiers
NCT: NCT06861010 · 54782