Clinical trial NCT06535490: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Cystic Lesion
Keywords: EUS-FNA
Pancreatic cystic lesion
Antibiotic prophylaxis
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 1702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic cystic lesions for whom an EUS-FNA is indicated

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.

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.

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

Primary outcomes:
measure: Post EUS-FNA PCL infection rate
timeFrame: 30 days
Secondary outcomes:
measure: Rate of urinary infectious complications
timeFrame: 30 days
measure: Rate of post-ATBp allergic reactions
timeFrame: 30 days
measure: Duration and extension of hospitalization
timeFrame: 30 days
measure: Diameter of the needle used for EUS-FNA
timeFrame: 1 days
measure: Associated procedures (confocal endomicroscopy or intracystic biopsy)
timeFrame: 1 days
measure: Appearance of the fluid
timeFrame: 1 day
measure: Complete aspiration of the cyst fluid
timeFrame: 1 day
measure: Nature of the PCL
timeFrame: 30 days
measure: Age
timeFrame: 1 day
measure: Gender
timeFrame: 1 day
measure: Diabetes
timeFrame: 1 day
measure: Immunosuppression
timeFrame: 1 day
measure: BMI
timeFrame: 1 day
measure: history of aspiration of the same lesion
timeFrame: 1 day
measure: Rate of pulmonary infectious complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Charenton-le-Pont
country: France
facility: Clinique Paris-Bercy
Study officials:
affiliation: Societe Française d'Endoscopie Digestive
name: David KARSENTI
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.