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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02261896 |
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Date of registration:
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07/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Antibiotic Prophylaxis for Endoscopic Ultrasound Guided Fine Needle Aspiration of Pancreatic Cystic Lesions
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Scientific title:
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Multicenter, Randomized and Double-blinded Clinical Trial on the Use of Antibiotic Prophylaxis for EUS Guided FNA of Pancreatic Cystic Lesions |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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226 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02261896 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Contacts
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Name:
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Carlos Guarner-Argente, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pancreatic Cystic Lesion
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Intervention(s)
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Drug: Placebo
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Drug: Ciprofloxacin
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Primary Outcome(s)
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Risk of infection of a pancreatic cyst or infection related to the procedure
[Time Frame: 21 days]
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Secondary Outcome(s)
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secondary effects, allergic reactions, and drug resistant or secondary infections
[Time Frame: 21 days]
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Risk of fever
[Time Frame: 21 days]
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Secondary ID(s)
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IIBSP-CIP-2013-166
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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