Pancreatic Cystic Lesion
Conditions
Keywords
EUS-FNA, Pancreatic cystic lesion, Antibiotic prophylaxis
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.
Interventions
PROCEDUREEUS-FNA
Puncture of pancreatic cystic lesion with a fine needle under EUS guidance
DRUGATBp
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
Sponsors
Société Française d'Endoscopie Digestive
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of post-ATBp allergic reactions | 30 days | Number of patients with at least one allergic reaction within 21-30 days after EUS-FNA |
| 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 |
| Rate of urinary infectious complications | 30 days | Number of patients with at least one urinary infection within 21-30 days after EUS-FNA |
| Gender | 1 day | Male or female |
| Diabetes | 1 day | Yes or No |
| Immunosuppression | 1 day | Yes or No |
| BMI | 1 day | Weight/(size)2 expressed in in kg/m\^2 |
| history of aspiration of the same lesion | 1 day | Yes or No |
| Rate of pulmonary infectious complications | 30 days | Number of patients with at least one pulmonary infection within 21-30 days after EUS-FNA |
| Age | 1 day | Years |
Countries
France
Contacts
Primary ContactDavid KARSENTI, MD
Outcome results
None listed