Prophylaxis of Post-ERCP Acute Pancreatitis (NCT05381428) | Clinical Trial Compass
CompletedPhase 3
Prophylaxis of Post-ERCP Acute Pancreatitis
Italy184 participantsStarted 2022-05-13
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years;
* All naĂ¯ve 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 \> 15…