Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions

NCT06535490 | Not Yet Recruiting

• 1 other identifier: SFED-165
• Study Type: observational
• Target: 1,702
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cystic Lesion

Keywords

EUS-FNA; Pancreatic cystic lesion; Antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Post EUS-FNA PCL infection rate

  Post-EUS-FNA infection rate of PCL (patients exhibiting clinical and biological signs - fever \>38.5°C, neutrophilic leukocytosis, elevated CRP, pathogen identification in blood cultures - indicative of sepsis requiring prolonged antibiotic therapy). The occurrence of the aforementioned clinical and biological signs, along with imaging evidence (such as cyst wall thickening or presence of intracystic air images) and the absence of another infection source (urinary, pulmonary, venous, etc.) will lead to the diagnosis of post-FNA infection. Centralized validation of infection cases will be conducted by an expert panel based on clinical, biological, and imaging findings.

  30 days

Secondary Outcomes (15)

• Rate of urinary infectious complications

  30 days

• Rate of post-ATBp allergic reactions

  30 days

• Duration and extension of hospitalization

  30 days

• Diameter of the needle used for EUS-FNA

  1 days

• Associated procedures (confocal endomicroscopy or intracystic biopsy)

  1 days

Study Arms (2)

EUS-FNA for PCL with ATBp

Patients undergoing EUS-FNA for pancreatic cystic lesions WITH ATBp

Procedure: EUS-FNA; Drug: ATBp

EUS-FNA for PCL without ATBp

Patients undergoing EUS-FNA for pancreatic cystic lesions without ATBp

Procedure: EUS-FNA

Interventions

EUS-FNA PROCEDURE

Puncture of pancreatic cystic lesion with a fine needle under EUS guidance

Also known as: EUS fine needle aspiration

EUS-FNA for PCL with ATBp; EUS-FNA for PCL without ATBp

ATBp DRUG

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

Also known as: Antibiotic prophylaxis

EUS-FNA for PCL with ATBp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic cystic lesions for whom an EUS-FNA is indicated

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (1)

Clinique Paris-Bercy

Charenton-le-Pont, 94220, France

Location

Related Publications (8)

• 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 Guideline - March 2017. Endoscopy. 2017 Oct;49(10):989-1006. doi: 10.1055/s-0043-119219. Epub 2017 Sep 12.

  PMID: 28898917 RESULT

• 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 RESULT

• 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/diagnostics12010211.

  PMID: 35054378 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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):1642-1649.e1. doi: 10.1053/j.gastro.2020.01.025. Epub 2020 Jan 20.

  PMID: 31972236 RESULT

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Antibiotic Prophylaxis

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Chemoprevention; Drug Therapy; Therapeutics; Premedication

Study Officials

• David KARSENTI

  Societe Française d'Endoscopie Digestive

  STUDY CHAIR

Central Study Contacts

David KARSENTI, MD

CONTACT

+33 1 43 96 78 50; karsenti.paris@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Principal Investigator

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: August 2, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)