Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions

Official title

Prevention of Infection After EUS-FNA of Pancreatic Cystic Lesions: A French Multicenter Prospective Comparative Observational Study

Overview

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.

Detailed description

The complication rate after EUS fine needle aspiration (EUS-FNA) for pancreatic cystic lesions (PCL) is low, around 1-3% according to various series. However, it has long been recommended to perform this procedure under antibiotic prophylaxis (ATBp). Due to the risk of developing resistance to certain classes of antibiotics and the risk of complications, particularly allergic reactions, the role of ATBp in this indication needs to be reconsidered. The latest recommendations from European and French societies do not support the systematic formal indication of ATBp for aspiration under EUS. Because the literature on the subject is sparse and equivocal, practices remain varied (some performing PCL aspirations with and others without ATBp), and scientific societies do not provide a formal stance on the benefit of such ATBp. Therefore, we decided to conduct a very large prospective comparative observational study in numerous reference centers in France (centers of the Research and Action Group in Endoscopy - GRAPHE), comparing infectious complications in patients admitted for EUS-FNA for PCL performed with or without ATBp according to the usual practices .

This is a prospective, comparative, observational, multicenter study.

Primary objective:

Comparison of infection rates after EUS-FNA for pancreatic cystic lesions (PCL) , with and without the administration of ATBp.

Secondary objectives:

Rates of other infectious complications (pulmonary, urinary, etc.) Rates of post-ATBp complications, particularly allergic reactions Prolongation of scheduled hospitalization Evaluation of factors associated with post-EUS aspiration infection of PCL

After the endoscopic exploration, the patient will be monitored for the potential occurrence of complications related to EUS (perforation, hemorrhage, infection, allergy, etc.). Any adverse events will be recorded at 30 days post-procedure.

A sample size of 1702 patients will be needed over a 3-year study period.

Interventions

• Procedure EUS-FNA
  Puncture of pancreatic cystic lesion with a fine needle under EUS guidance
• Drug ATBp
  Antibiotic prophylaxis consists of a single intravenous administration before or at the beginning of the procedure according to the common practices of each practitioner or unit

Primary outcome measures

• Post EUS-FNA PCL infection rate [Time frame: 30 days]

Secondary outcome measures (12)

• Rate of urinary infectious complications [Time frame: 30 days]
• Rate of post-ATBp allergic reactions [Time frame: 30 days]
• Duration and extension of hospitalization [Time frame: 30 days]
• Diameter of the needle used for EUS-FNA [Time frame: 1 days]
• Associated procedures (confocal endomicroscopy or intracystic biopsy) [Time frame: 1 days]
• Appearance of the fluid [Time frame: 1 day]
• Complete aspiration of the cyst fluid [Time frame: 1 day]
• Nature of the PCL [Time frame: 30 days]
• Age [Time frame: 1 day]
• Gender [Time frame: 1 day]
• Diabetes [Time frame: 1 day]
• Immunosuppression [Time frame: 1 day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Clinique Paris-Bercy — Charenton-le-Pont

Publications

• Polkowski M, Jenssen C, Kaye P, Carrara S, Deprez P, Gines A, Fernandez-Esparrach G, Eisendrath P, Aithal GP, Arcidiacono P, Barthet M, Bastos P, Fornelli A, Napoleon B, Iglesias-Garcia J, Seicean A, Larghi A, Hassan C, van Hooft JE, Dumonceau JM. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Gu PMID 28898917
• Facciorusso A, Mohan BP, Tacelli M, Crino SF, Antonini F, Fantin A, Barresi L. Use of antibiotic prophylaxis is not needed for endoscopic ultrasound-guided fine-needle aspiration of pancreatic cysts: a meta-analysis. Expert Rev Gastroenterol Hepatol. 2020 Oct;14(10):999-1005. doi: 10.1080/17474124.2020.1797486. Epub 2020 Jul 25. PMID 32674699
• Facciorusso A, Arevalo-Mora M, Conti Bellocchi MC, Bernardoni L, Ramai D, Gkolfakis P, Loizzi D, Muscatiello N, Ambrosi A, Tartaglia N, Robles-Medranda C, Stasi E, Ofosu A, Crino SF. Impact of Antibiotic Prophylaxis on Infection Rate after Endoscopic Ultrasound Through-the-Needle Biopsy of Pancreatic Cysts: A Propensity Score-Matched Study. Diagnostics (Basel). 2022 Jan 16;12(1):211. doi: 10.3390/ PMID 35054378
• Facciorusso A, Buccino VR, Turco A, Antonino M, Muscatiello N. Antibiotics Do Not Decrease the Rate of Infection After Endoscopic Ultrasound Fine-Needle Aspiration of Pancreatic Cysts. Dig Dis Sci. 2019 Aug;64(8):2308-2315. doi: 10.1007/s10620-019-05655-x. Epub 2019 May 7. PMID 31065897
• Klein A, Qi R, Nagubandi S, Lee E, Kwan V. Single-dose intra-procedural ceftriaxone during endoscopic ultrasound fine-needle aspiration of pancreatic cysts is safe and effective: results from a single tertiary center. Ann Gastroenterol. 2017;30(2):237-241. doi: 10.20524/aog.2016.0118. Epub 2016 Dec 22. PMID 28243046
• Guarner-Argente C, Shah P, Buchner A, Ahmad NA, Kochman ML, Ginsberg GG. Use of antimicrobials for EUS-guided FNA of pancreatic cysts: a retrospective, comparative analysis. Gastrointest Endosc. 2011 Jul;74(1):81-6. doi: 10.1016/j.gie.2011.03.1244. PMID 21704808
• Lee LS, Saltzman JR, Bounds BC, Poneros JM, Brugge WR, Thompson CC. EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. Clin Gastroenterol Hepatol. 2005 Mar;3(3):231-6. doi: 10.1016/s1542-3565(04)00618-4. PMID 15765442
• Colan-Hernandez J, Sendino O, Loras C, Pardo A, Gornals JB, Concepcion M, Sanchez-Montes C, Murzi M, Andujar X, Velasquez-Rodriguez J, Rodriguez de Miguel C, Fernandez-Esparrach G, Gines A, Guarner-Argente C. Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial. Gastroenterology. 2020 May;158(6 PMID 31972236

Identifiers

NCT: NCT06535490 · SFED-165

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗