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

Phase 3RecruitingNCT06861010

Tanta University44 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pancreatic Diseases

Interventions

PlaceboOTHER

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

OndansetronDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta Unuversity

Tanta, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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