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Antibiotic Prophylaxis for Endoscopic Ultrasound Guided Fine Needle Aspiration of Pancreatic Cystic Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02261896
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cystic Lesion Drug: Placebo Drug: Ciprofloxacin Phase 4

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Placebo
1 intravenous dose followed by 1 oral dose each 12 hours (complete 3 days)
Drug: Placebo
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)
Drug: Ciprofloxacin
Ciprofloxacine 400 mg intravenous one dose followed by ciprofloxacine oral each 12 hours (complete 3 days)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. secondary effects, allergic reactions, and drug resistant or secondary infections [ Time Frame: 21 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Spanish Clinical Research Network - CAIBER
Investigators
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Principal Investigator: Carlos Guarner-Argente, MD, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02261896    
Other Study ID Numbers: IIBSP-CIP-2013-166
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
cyst
pancreatic cyst
EUS-FNA
antibiotic prophylaxis
Additional relevant MeSH terms:
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Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors