Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions
- Conditions
- Pancreatic Cystic Lesion
- Interventions
- Procedure: EUS-FNADrug: ATBp
- Registration Number
- NCT06535490
- Lead Sponsor
- Société Française d'Endoscopie Digestive
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1702
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EUS-FNA for PCL without ATBp EUS-FNA Patients undergoing EUS-FNA for pancreatic cystic lesions without ATBp EUS-FNA for PCL with ATBp EUS-FNA Patients undergoing EUS-FNA for pancreatic cystic lesions WITH ATBp EUS-FNA for PCL with ATBp ATBp Patients undergoing EUS-FNA for pancreatic cystic lesions WITH ATBp
- Primary Outcome Measures
Name Time Method Post EUS-FNA PCL infection rate 30 days 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.
- Secondary Outcome Measures
Name Time Method history of aspiration of the same lesion 1 day Yes or No
Rate of urinary infectious complications 30 days Number of patients with at least one urinary infection within 21-30 days after EUS-FNA
Rate of post-ATBp allergic reactions 30 days Number of patients with at least one allergic reaction within 21-30 days after EUS-FNA
Diabetes 1 day Yes or No
Immunosuppression 1 day Yes or No
BMI 1 day Weight/(size)2 expressed in in kg/m\^2
Duration and extension of hospitalization 30 days Number of hospitalization days per stay within 30 days following EUS-FNA
Diameter of the needle used for EUS-FNA 1 days 25G, 22G, 20G, or 19G
Associated procedures (confocal endomicroscopy or intracystic biopsy) 1 days Yes or No
Appearance of the fluid 1 day Thin, thick, hemorrhagic
Complete aspiration of the cyst fluid 1 day Yes or No
Nature of the PCL 30 days mucinous vs. non-mucinous
Age 1 day Years
Gender 1 day Male or female
Rate of pulmonary infectious complications 30 days Number of patients with at least one pulmonary infection within 21-30 days after EUS-FNA
Trial Locations
- Locations (1)
Clinique Paris-Bercy
🇫🇷Charenton-le-Pont, France