RecruitingPhase 3

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

Egypt44 participantsStarted 2025-03-10

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary outcome that will be measured is the development of pancreatitis after the procedure

Timeframe: 24 hours

Trial details

NCT IDNCT06860984

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-20

View on ClinicalTrials.gov More Biliary Disease trials