Prophylaxis of Post-ERCP Acute Pancreatitis (PEPPER)
Pancreatitis, Acute
About this trial
This is an interventional prevention trial for Pancreatitis, Acute
Eligibility 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.
Sites / Locations
- Azienda Ospedaliero-Universitaria di Modena - Ospedale civile di Baggiovara
- Azienda USL di Modena - Ospedale di Carpi
- Ospedale di Fidenza - AUSL di Parma
- AUSL Bologna - Ospedale Maggiore Carlo Alberto Pizzardi
- IRCSS - Policlinico S.Orsola-Malpighi
- Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale sant'Anna
- AUSL della Romagna - Ospedale Morgagni-Pierantoni di Forlì
- Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
- Azienda Ospedaliero - Universitaria di Parma
- Ospedale Guglielmo da Saliceto - AUSL Piacenza
- AUSL Romagna - Ospedale Santa Maria delle Croci
- AUSL- IRCCS di Reggio EmiliaRecruiting
- AUSL della Romagna - Ospedale Infermi di Rimini
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Indomethacin Group (Control Arm)
Indomethacin and Lactated Ringer Group (Intervention Arm)
Patients will be randomized to receive a 100 mg indomethacin suppository will be administered immediately before the endoscopic procedure (20-30 minutes) and saline infusion will be given as needed.
Patients will be randomized to receive an indomethacin suppository that will be administered immediately before (20-30 minutes) the endoscopic procedure in combination with a lactated Ringer's infusion that will be administered with the following weight-based schedule: 3 cc/kg/h during ERCP, a bolus of 20 cc/kg after ERCP, and again 3 cc/kg/h for 8 hours after ERCP.