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Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions

NCT06535490 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1702

Last updated 2024-08-02

No results posted yet for this study

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.

Conditions

  • Pancreatic Cystic Lesion

Interventions

PROCEDURE

EUS-FNA

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

DRUG

ATBp

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 & Collaborators

  • Société Française d'Endoscopie Digestive

    lead OTHER

Principal Investigators

  • David KARSENTI · Societe Française d'Endoscopie Digestive

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2027-09-15
Completion
2027-10-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06535490 on ClinicalTrials.gov