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

NCT06860984 | Recruiting Phase 3

• 1 other identifier: 5487
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Disease

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 hours

Study Arms (2)

Control group

PLACEBO COMPARATOR

The patients will receive placebo capsule placebo tablet 2 h before ERCP.

Other: Placebo capsule

Duloxetine group

ACTIVE COMPARATOR

The patients will receive 60 mg duloxetine 2 h before ERCP.

Drug: Duloxetine

Interventions

Duloxetine DRUG

Duloxetine, a non-opioid neuromodulator, has been widely used to manage neuropathic pain. It possesses dual central and peripheral analgesic properties

Duloxetine group

Placebo capsule OTHER

Placebo will have the same look and appearance of active comparator

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Gallbladder Diseases

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

EG (1)