Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Egypt
Tanta Unuversity
RECRUITING
Tanta
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2026-07-10
Participants
Target number of participants: 44
Treatments
Placebo_comparator: Control group
The patients will receive placebo capsule placebo tablet 2 h before ERCP.
Active_comparator: Duloxetine group
The patients will receive 60 mg duloxetine 2 h before ERCP.
Related Therapeutic Areas
Sponsors
Leads: Tanta University