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 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: * 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

What they're measuring

Post EUS-FNA PCL infection rate

Timeframe: 30 days

Trial details

NCT IDNCT06535490

SponsorSociété Française d'Endoscopie Digestive

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09-15

Contact for this trial

David KARSENTI, MD

+33 1 43 96 78 50 karsenti.paris@gmail.com

View on ClinicalTrials.gov More Pancreatic Cystic Lesion trials