Using Duloxetine to prevent pancreatitis after ERCP procedures
Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
This study is testing if the medication Duloxetine can help prevent pancreatitis in patients undergoing a procedure called ERCP.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT06860984 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Duloxetine in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, a common complication that can lead to serious health issues. The study involves administering Duloxetine or a placebo to patients who are undergoing ERCP for suspected pancreato-biliary disorders. Participants will be monitored for the occurrence of pancreatitis following the procedure, with the aim of determining whether Duloxetine can reduce the incidence of this complication.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with indications for ERCP due to suspected pancreato-biliary disorders and normal blood amylase and lipase levels.
Not a fit: Patients with uncontrolled diabetes, severe bleeding tendencies, impaired renal function, severe heart disease, or those who have had prior biliary or pancreatic interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of pancreatitis in patients undergoing ERCP, improving patient outcomes and reducing healthcare costs.
How similar studies have performed: While there may be studies exploring similar interventions, the specific use of Duloxetine for preventing post-ERCP pancreatitis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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: * 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.
Where this trial is running
Tanta
- Tanta Unuversity — Tanta, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.