Health TrialsbyHealthPanel

Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions

ConditionPancreatic Cystic Lesion
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociété Française d'Endoscopie Digestive

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with pancreatic cystic lesions for whom an EUS-FNA is indicated

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • EUS-FNA

    Procedure/Surgery

    Puncture of pancreatic cystic lesion with a fine needle under EUS guidance

  • ATBp

    Drug

    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

Treatment groups

1,702 Participants
are divided into 2 treatment groups
Group A: EUS-FNA for PCL with ATBp2 interventions
Group B: EUS-FNA for PCL without ATBp1 intervention

Trial outcomes

Primary outcomes

1

Post EUS-FNA PCL infection rate

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.

Time frame
30 days

Secondary outcomes

1

Rate of urinary infectious complications

Number of patients with at least one urinary infection within 21-30 days after EUS-FNA

Time frame
30 days
2

Rate of post-ATBp allergic reactions

Number of patients with at least one allergic reaction within 21-30 days after EUS-FNA

Time frame
30 days
3

Duration and extension of hospitalization

Number of hospitalization days per stay within 30 days following EUS-FNA

Time frame
30 days
4

Diameter of the needle used for EUS-FNA

25G, 22G, 20G, or 19G

Time frame
1 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Société Française d'Endoscopie Digestive

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: