Clinical trial · Interventional
Antibiotic Prophylaxis for Endoscopic Ultrasound Guided Fine Needle Aspiration of Pancreatic Cystic Lesions
Multicenter, Randomized and Double-blinded Clinical Trial on the Use of Antibiotic Prophylaxis for EUS Guided FNA of Pancreatic Cystic Lesions
NCT02261896CI-TRIAL-00038092completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the use of antibiotic prophylaxis is appropriate when performing a pancreatic cyst fine needle aspiration guided by endoscopic ultrasonography.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cystic Lesion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ciprofloxacin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Placebo
- description
- 1 intravenous dose followed by 1 oral dose each 12 hours (complete 3 days)
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Antibiotic
- description
- Ciprofloxacin 400 mg intravenous one dose followed by ciprofloxacin 500 mg oral each 12 hours (complete 3 days)
- interventionNames
- Drug: Ciprofloxacin
Primary outcomes (1)
- measure
- Risk of infection of a pancreatic cyst or infection related to the procedure
- timeFrame
- 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a pancreatic cyst requiring EUS-FNA to complete evaluation. * Participant is willing and able to give informed consent for participation in the study. * Age 18 years or older. * Ability to understand study procedures and to comply with them for the entire length of the study. Exclusion Criteria: * Patients with other co-morbidities requiring antibiotic prophylaxis for endoscopic invasive procedures (such as those with cardiac valve prosthesis). * Cystic lesion of the intestinal wall (foregut or duplication cyst). * Use of antibiotic treatment for any other indication during the 5 days prior to the procedure. * Pregnant woman. * Known allergy/sensitivity to ciprofloxacin. * Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
References
Publications (1)
- DERIVEDColan-Hernandez J, Sendino O, Loras C, Pardo A, Gornals JB, Concepcion M, Sanchez-Montes C, Murzi M, Andujar X, Velasquez-Rodriguez J, Rodriguez de Miguel C, Fernandez-Esparrach G, Gines A, Guarner-Argente C. Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial. Gastroenterology. 2020 May;158(6):1642-1649.e1. doi: 10.1053/j.gastro.2020.01.025. Epub 2020 Jan 20. PMID 31972236