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

NCT06861010 | Recruiting Phase 3

• 1 other identifier: 54782
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Diseases

Outcome Measures

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

  24 hours

Study Arms (2)

Control group

PLACEBO COMPARATOR

the patients will receive placebo tablet 2 h before ERCP

Other: Placebo

ondansetron group

ACTIVE COMPARATOR

the patients will receive placebo tablet 2 h before ERCP.

Drug: Ondansetron

Interventions

Ondansetron DRUG

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

ondansetron group

Placebo OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Diseases

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

EG (1)