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 range
18 Years
Sex
ALL
See this in plain English?
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 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 \> 15…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.