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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTanta University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Other intervention

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

  • Ondansetron

    Drug

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

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Control groupPlacebo comparator 1 intervention
Group B: ondansetron groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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