NCT06860984 Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
| NCT ID | NCT06860984 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tanta University |
| Condition | Biliary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2026-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 44 participants in total. It began in 2025-03-10 with a primary completion date of 2026-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT06860984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Biliary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06860984 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 44 participants.
Is NCT06860984 currently recruiting?
Yes, NCT06860984 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tanta University to inquire about joining.
Where is the NCT06860984 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT06860984 clinical trial?
NCT06860984 is sponsored by Tanta University. The trial plans to enroll 44 participants.