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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06860984

Enrollment

Registered

2025-03-06

Start date

2025-03-10

Completion date

2027-07-10

Last updated

2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Disease

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.

Interventions

DRUGDuloxetine

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

OTHERPlacebo capsule

Placebo will have the same look and appearance of active comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

double blinded

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026