Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions
NCT ID: NCT06535490
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
1702 participants
OBSERVATIONAL
2024-09-15
2027-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
EUS Guided Drainage of Post Pancreatitis Pancreatic Fluid Collection
NCT06280248
EUS-guided Ablation of Pancreatic Cyst Neoplasms
NCT02422147
Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective Registry
NCT07136324
Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent
NCT01239056
Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
NCT02958059
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EUS-FNA for PCL with ATBp
Patients undergoing EUS-FNA for pancreatic cystic lesions WITH ATBp
EUS-FNA
Puncture of pancreatic cystic lesion with a fine needle under EUS guidance
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
EUS-FNA for PCL without ATBp
Patients undergoing EUS-FNA for pancreatic cystic lesions without ATBp
EUS-FNA
Puncture of pancreatic cystic lesion with a fine needle under EUS guidance
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EUS-FNA
Puncture of pancreatic cystic lesion with a fine needle under EUS guidance
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Société Française d'Endoscopie Digestive
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David KARSENTI
Medical doctor, Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David KARSENTI
Role: STUDY_CHAIR
Societe Française d'Endoscopie Digestive
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinique Paris-Bercy
Charenton-le-Pont, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SFED-165
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.