Antibiotic Prophylaxis for Endoscopic Ultrasound Guided Fine Needle Aspiration of Pancreatic Cystic Lesions

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau226 enrolled

Overview

The purpose of this study is to determine whether the use of antibiotic prophylaxis is appropriate when performing a pancreatic cyst fine needle aspiration guided by endoscopic ultrasonography.

The incidence of infection after a pancreatic cyst fine needle aspiration guided by endoscopic ultrasonography (EUS-FNA) is not well known. Antibiotic prophylaxis is recommended in clinical guidelines despite the lack of evidence of its usefulness. Our hypothesis is that the risk of infection will not be higher with placebo, and risks associated to the use of antibiotics might even increase with the use of prophylaxis. The main objective of the project is to assess the risk of infection after the procedure and to determine whether the use of antibiotic prophylaxis is appropriate. The study is a phase IV, multicenter, double-blinded, randomized, placebo-controlled, and non-inferiority trial . We have designed a study with two parallel treatment groups. Patients will be randomized to the prophylaxis or to the placebo group. All patients will be followed for 21 days or until resolution of complications. To evaluate this primary objective with a non inferiority study, we have estimated that a total of 218 patients will be needed (109 per group) . The main secondary objective is to assess the incidence of complications related to the use of antibiotic prophylaxis (i.e. allergic reactions, secondary infections or drug-resistant infections).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

226

Conditions

Pancreatic Cystic Lesion

Interventions

PlaceboDRUG

Evaluate usefullness of antibiotic prophylaxis

CiprofloxacinDRUG

Ciprofloxacine 400 mg intravenous one dose followed by ciprofloxacine oral each 12 hours (complete 3 days)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * Patients with other co-morbidities requiring antibiotic prophylaxis for endoscopic invasive procedures (such as those with cardiac valve prosthesis). * Cystic lesion of the intestinal wall (foregut or duplication cyst). * Use of antibiotic treatment for any other indication during the 5 days prior to the procedure. * Pregnant woman. * Known allergy/sensitivity to ciprofloxacin. * Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Locations (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Outcomes

Primary Outcomes

Risk of infection of a pancreatic cyst or infection related to the procedure

The infection can be defined as "confirmed" if there is a positive culture of the lesion content or if there is suspicion by clinical and image techniques (CT, MRI), and a positive blood culture is obtained. It will be defined as "suspected" when clinical and/or image is suggestive of cyst infection, but microbial confirmation is not obtained.

Time frame: 21 days

Secondary Outcomes

Risk of fever

This will be measured prior to discharge. In case of clinical suspicion of bacteraemia at any moment during the follow up, blood cultures will be obtained.

Time frame: 21 days

secondary effects, allergic reactions, and drug resistant or secondary infections

Time frame: 21 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.