Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions (NCT06535490) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions
France1,702 participantsStarted 2024-09-15
Plain-language summary
Large prospective comparative observational study in numerous reference centers in France, comparing infectious complications in patients admitted for pancreatic cystic lesions (PCL) aspiration performed with or without antibiotic prophylaxis (ATBp) according to the usual practices.
This is a prospective, comparative, observational, multicenter study, with the primary objective of comparing the infection rates in pancreatic cystic lesions (PCL) aspirated under EUS, with and without the administration of ATBp.
A sample size of 1702 patients will be needed over a 3-year study period.
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:
* Patient referred for diagnostic aspiration of a pancreatic cystic lesion
* Patient aged 18 years or older
* Patient with ASA 1, ASA 2, ASA 3 status
* No participation in another concurrent clinical study
Exclusion Criteria:
* Patient under 18 years old
* Patient with ASA 4 or ASA 5 status
* Pregnant woman
* Patient with coagulation disorders preventing the performance of an EUS-FNA: PT \< 50%, platelets \< 50,000/mm³, current effective anticoagulation, ongoing clopidogrel, prasugrel, or ticagrelor treatment
* Patient unable to personally express non-opposition or legally protected adult
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.
1This trial is looking at whether antibiotic prophylaxis actually reduces infection rates after EUS-FNA of pancreatic cysts — does my doctor currently give antibiotics before this procedure, and what is the evidence behind that practice right now?
2Since this trial is listed as 'not yet recruiting,' how long might it be before it opens and accepts patients, and is waiting for it a realistic option given my situation?
3The trial is measuring infection rates after EUS-FNA of pancreatic cystic lesions — how common is that infection risk in general, and how does it compare to other risks of the procedure I should be aware of?
4This study is listed as Phase NA, which often means it's more of a procedural or comparative study rather than a drug trial — can my doctor explain what that means for what we'd learn about safety and benefit from participating?
5If I'm a potential candidate for EUS-FNA of my pancreatic cyst, would my doctor recommend going ahead with the procedure now under standard care, or could waiting to see if this trial opens nearby be worth considering given my current symptoms and cyst characteristics?
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.