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

Phase 3

Recruiting

• Conditions: Biliary Disease
• Interventions: Other: Placebo capsule; Drug: Duloxetine

• Registration Number: NCT06860984
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-01
• Study First Submitted QC: 2025-03-01
• Study First Posted: 2025-03-06
• Study Start: 2025-03-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-06-20
• Study Completion: 2025-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo capsule	The patients will receive placebo capsule placebo tablet 2 h before ERCP.
Duloxetine group	Duloxetine	The patients will receive 60 mg duloxetine 2 h before ERCP.

Primary Outcome Measures

Name	Time	Method
The primary outcome that will be measured is the development of pancreatitis after the procedure	24 hours	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.

Trial Locations

Locations (1)

Tanta Unuversity; 🇪🇬 Tanta, Egypt