Status:
COMPLETED
Prophylaxis of Post-ERCP Acute Pancreatitis
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Conditions:
Pancreatitis, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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).
Detailed Description
This study aims to compare indomethacin and the combination of indomethacin and aggressive lactated Ringer infusion in terms of their efficacy in preventing PEP regardless of baseline risk in all elig...
Eligibility Criteria
Inclusion
- Age \> 18 years;
- All naïve patients consecutively undergoing ERCP and with any indication;
- Obtaining informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2024
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT05381428
Start Date
May 13 2022
End Date
October 12 2024
Last Update
June 24 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliero-Universitaria di Modena - Ospedale civile di Baggiovara
Baggiovara, Modena, Italy, 41126
2
Azienda USL di Modena - Ospedale di Carpi
Carpi, Modena, Italy, 41121
3
AUSL Bologna - Ospedale Maggiore Carlo Alberto Pizzardi
Bologna, Italy, 40133
4
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale sant'Anna
Ferrara, Italy, 44124