Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions
ConditionPancreatic Cystic Lesion
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociété Française d'Endoscopie Digestive
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- EUS-FNA
- ATBp
Treatment groups
1,702 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov