Antibiotic Prophylaxis for Endoscopic Ultrasound Guided Fine Needle Aspiration of Pancreatic Cystic Lesions
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|ClinicalTrials.gov Identifier: NCT02261896|
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cystic Lesion||Drug: Placebo Drug: Ciprofloxacin||Phase 4|
The incidence of infection after a pancreatic cyst fine needle aspiration guided by endoscopic ultrasonography (EUS-FNA) is not well known. Antibiotic prophylaxis is recommended in clinical guidelines despite the lack of evidence of its usefulness.
Our hypothesis is that the risk of infection will not be higher with placebo, and risks associated to the use of antibiotics might even increase with the use of prophylaxis.
The main objective of the project is to assess the risk of infection after the procedure and to determine whether the use of antibiotic prophylaxis is appropriate. The study is a phase IV, multicenter, double-blinded, randomized, placebo-controlled, and non-inferiority trial . We have designed a study with two parallel treatment groups. Patients will be randomized to the prophylaxis or to the placebo group. All patients will be followed for 21 days or until resolution of complications. To evaluate this primary objective with a non inferiority study, we have estimated that a total of 218 patients will be needed (109 per group) .
The main secondary objective is to assess the incidence of complications related to the use of antibiotic prophylaxis (i.e. allergic reactions, secondary infections or drug-resistant infections).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Multicenter, Randomized and Double-blinded Clinical Trial on the Use of Antibiotic Prophylaxis for EUS Guided FNA of Pancreatic Cystic Lesions|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
1 intravenous dose followed by 1 oral dose each 12 hours (complete 3 days)
Evaluate usefullness of antibiotic prophylaxis
Active Comparator: Antibiotic
Ciprofloxacin 400 mg intravenous one dose followed by ciprofloxacin 500 mg oral each 12 hours (complete 3 days)
Ciprofloxacine 400 mg intravenous one dose followed by ciprofloxacine oral each 12 hours (complete 3 days)
- Risk of infection of a pancreatic cyst or infection related to the procedure [ Time Frame: 21 days ]The infection can be defined as "confirmed" if there is a positive culture of the lesion content or if there is suspicion by clinical and image techniques (CT, MRI), and a positive blood culture is obtained. It will be defined as "suspected" when clinical and/or image is suggestive of cyst infection, but microbial confirmation is not obtained.
- Risk of fever [ Time Frame: 21 days ]This will be measured prior to discharge. In case of clinical suspicion of bacteraemia at any moment during the follow up, blood cultures will be obtained.
- secondary effects, allergic reactions, and drug resistant or secondary infections [ Time Frame: 21 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261896
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Principal Investigator:||Carlos Guarner-Argente, MD, PhD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|