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

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.

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Key information

Conditions

Biliary Disease Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tanta Unuversity

Tanta, 31527, Egypt

Location status: Recruiting

Location contact

Mostafa M Bahaa, PhD

SUB_INVESTIGATOR

Mostafa M I Bahaa, PhD

CONTACT

[email protected]

0201025538337

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine

Drug

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

Placebo capsule

Other

Placebo will have the same look and appearance of active comparator

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 6, 2025
Registry last updated: Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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