Endoscopy 2019; 51(04): S112-S113
DOI: 10.1055/s-0039-1681502
ESGE Days 2019 oral presentations
Saturday, April 6, 2019 11:00 – 13:00: Best abstract awards Congress Hall
Georg Thieme Verlag KG Stuttgart · New York

ANTIBIOTIC PROPHYLAXIS FOR EUS GUIDED FNA OF PANCREATIC CYSTIC LESIONS: A MULTICENTER, RANDOMIZED AND DOUBLE BLINDED CLINICAL TRIAL

J Colan Hernandez
1   Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
,
O Sendino
2   Hospital Clinic de Barcelona, Barcelona, Spain
,
C Loras
3   Hospital Mutua Terrassa, Terrassa, Spain
,
X Andujar
3   Hospital Mutua Terrassa, Terrassa, Spain
,
A Pardo
4   Hospital Joan XIII, Tarragona, Spain
,
J Gornals
5   Hospital de Belvitge, Barcelona, Spain
,
M Concepcion
1   Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
,
C Sanchez Montes
2   Hospital Clinic de Barcelona, Barcelona, Spain
,
M Murzi
1   Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
,
G Fernandez Esparrach
2   Hospital Clinic de Barcelona, Barcelona, Spain
,
A Gines
2   Hospital Clinic de Barcelona, Barcelona, Spain
,
C Guarner Argente
1   Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
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Publikationsverlauf

Publikationsdatum:
18. März 2019 (online)

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Aims:

Routine antibiotic prophylaxis for EUS-FNA of pancreatic cysts is suggested in guidelines, but evidence is conflicting. The aim of the study was to investigate whether the procedure without antimicrobial prophylaxis does not increase the incidence of infection.

Methods:

We conducted a multicenter, randomized, non-inferiority clinical trial controlled with parallel treatment from September 2014 to June 2018. Patients were randomized to the prophylaxis group with ciprofloxacin (ATB) or the non-prophylaxis group (placebo). Patient demographic data, lesion characteristics, and procedure data and 21 days follow-up were collected. For primary outcome analysis, cyst infection proportion, a non-inferiority study was performed (δ= 3%; unilateral α-error 0.05; power 20%). Secondary outcomes (incidence of fever, procedure complications, and other adverse events AEs) are reported as proportions and analyzed with the χ2 and Fisher exact test.

Results:

We included 226 patients, 112 in ATB and 114 in placebo group. 208 completed trial medications (92%). Demographics, baseline and procedure characteristic were similar in both groups. There were no cases of pancreatic cyst infection. As a surrogate marker of the primary endpoint we evaluated other FNA related infections. No events occurred in the ATB group, but one patient presented acute pancreatitis with bacteremia in the placebo group (0.87%) without signs of pancreatic cyst infection. In the intention to treat analysis, the placebo group was not inferior for prevention of infection with a difference between proportions of 0.87% (CI 95% -0.84 – 2.59%). For secondary outcomes, fever occurred in 2 patients in each group (1.76 vs. 1.78%; p = 1.00); other adverse events did not differ between groups. Per protocol analysis reported similar results.

Conclusions:

EUS-FNA of pancreatic cystic lesion without prophylaxis is not inferior to Ciprofloxacin prophylaxis to prevent the risk of infection.