Multicenter, randomized and double-blinded clinical trial on the use of antibiotic prophylaxis for EUS guided FNA of pancreatic cystic lesions

INTERVENTION: Trade Name: Ciprofloxacino Kabi 2 mg/ml solución para perfusión EFG Pharmaceutical Form: Solution for infusion INN or Proposed INN: CIPROFLOXACIN CAS Number: 85721‐33‐1 Other descriptive name: CIPROFLOXACIN (AS HCL, H2O) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Ciprofloxacino Normon 500 mg comprimidos recubiertos con película EFG Pharmaceutical Form: Coated tablet INN or Proposed INN: CIPROFLOXACIN CAS Number: 85721‐33‐1 Other descriptive name: CIPROFLOXACIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use CONDITION: Pancreatic cystic lesions Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] PRIMARY OUTCOME: Main Objective: To investigate if the EUS‐FNA of pancreatic cystic lesions without antimicrobial prophylaxis does not increase the risk of infection compared to the same procedure with antimicrobial prophylaxis. Primary end point(s): Incidence of infection of pancreatic cyst: expressed as a percentage. Infection was defined as "confirmed" positive culture if the content of the lesion or suspected by clinical or imaging techniques (CT, MRI) and no positive blood culture. Be defined as "suspicious" when there is clinical suspicion and / or suggestive image of cyst infection, but laboratory confirmation is obtained. Secondary Objective: 1. To assess the risk of fever after EUS‐FNA of a pancreatic cyst with and without antimicrobial prophylaxis.; 2. To assess secondary effects related to the use of prophylaxis (secondary effects, allergic reactions, and drug resistant or secondary infections) ; 3. To assess other complications of the procedure (bleeding, perforation). Timepoint(s) of evaluation of this end point: 21 days SECONDARY OUTCOME: Secondary end point(s): Risk of fever; Other complications (as bleeding or perforation); Secondary effects related to the use of prophylaxis (secondary effects, allergic reactions, and drug resistant or secondary infections) Timepoint(s) of evaluation of this end point: The evaluation of the secondary outcomes will be performed during the procedure and all the follow up period (21 days), and the follow up will be extended until it is solved. INCLUSION CRITERIA: ‐ Patients with a pancreatic cyst requiring EUS‐FNA to complete evaluation. ‐ Participant is willing and able to give informed consent for participation in the study. ‐ Age 18 years or older. ‐ Ability to understand study procedures and to comply with them for the entire length of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 218 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range