Prevention of Infection After EUS-FNA of Pancreatic Cystic Lesions: A French Multicenter Prospective Comparative Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,702
- Locations
- 1
- Primary Endpoint
- Post EUS-FNA PCL infection rate
Study Overview
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
EUS-FNA for PCL with ATBp
Patients undergoing EUS-FNA for pancreatic cystic lesions WITH ATBp
Intervention: EUS-FNA (Procedure)
EUS-FNA for PCL with ATBp
Patients undergoing EUS-FNA for pancreatic cystic lesions WITH ATBp
Intervention: ATBp (Drug)
EUS-FNA for PCL without ATBp
Patients undergoing EUS-FNA for pancreatic cystic lesions without ATBp
Intervention: EUS-FNA (Procedure)
Outcomes
Primary Outcomes
Post EUS-FNA PCL infection rate
Time Frame: 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 Outcomes
- history of aspiration of the same lesion(1 day)
- Rate of urinary infectious complications(30 days)
- Rate of post-ATBp allergic reactions(30 days)
- Diabetes(1 day)
- Immunosuppression(1 day)
- BMI(1 day)
- 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)
- Appearance of the fluid(1 day)
- Complete aspiration of the cyst fluid(1 day)
- Nature of the PCL(30 days)
- Age(1 day)
- Gender(1 day)
- Rate of pulmonary infectious complications(30 days)
Investigators
David KARSENTI
Medical doctor, Principal Investigator
Société Française d'Endoscopie Digestive