Prophylaxis of Post-ERCP Acute Pancreatitis

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to compare indomethacin and the combination of indomethacin and aggressive lactated Ringer infusion in terms of efficacy in preventing post-ERCP acute pancreatitis (PEP).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia
• Treatments: Indomethacin

Criteria

Inclusion Criteria:

• Age > 18 years;

• All naïve patients consecutively undergoing ERCP and with any indication;

• Obtaining informed consent.

Exclusion Criteria:

• Refusal or inability to sign informed consent;

• Patients undergoing ERCP for diagnostic purposes only;

• Patients with ongoing acute pancreatitis;

• Patients with known allergy/hypersensitivity to NSAIDs;

• Patients with hypersensitivity to the active ingredients or any of the excipients of Ringer

• Lactate;

• Patients with a personal or family history of Stevens-Johnson or Lyell syndrome;

• Patients already receiving treatment with NSAIDs within 7 days prior to ERCP;

• Patients with recent gastrointestinal bleeding (less than 30 days after ERCP), or with history of recurrent bleeding/ulcer peptic ulcer or bleeding/perforation after previous NSAID treatment;

• Patients who are candidates for or have previously undergone endoscopic papillectomy;

• Patients with a positive history of recent myocardial infarction (less than 6 months after the procedure), heart failure, severe myocardial insufficiency (NYHA class > II), respiratory failure with chronic need for oxygen therapy, known pulmonary hypertension;

• Patients with ventricular fibrillation;

• Patients with ongoing therapy with cardioactive glycosides;

• Patients with chronic renal failure (creatinine clearance values less than 40 ml/min);

• Cirrhotic patients in Child B and C class;

• Patients with severe hydro-electrolyte imbalances (hypernatremia > 150 mEq/L, hyponatremia < 130 mEq/L; hypercalcemia, hyperKalemia);

• Metabolic and respiratory alkalosis;

• Patients with epilepsy or Parkinson's disease;

• Patients with psychiatric disorders;

• Patients with a history of major surgery of the upper digestive tract (Billroth II, Roux-en-Y anastomosis);

• Pregnancy or lactation;

• Sarcoidosis;

• Untreated Addison's disease;

• Active proctitis of any etiology.