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Completed

NCT Number: NCT02261896

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

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.

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Key information

Conditions

Pancreatic Cystic Lesion Cysts Digestive System Diseases Neoplasms Pancreatic Cyst Pancreatic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Evaluate usefullness of antibiotic prophylaxis

Ciprofloxacin

Drug

Ciprofloxacine 400 mg intravenous one dose followed by ciprofloxacine oral each 12 hours (complete 3 days)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

Multicenter, Randomized and Double-blinded Clinical Trial on the Use of Antibiotic Prophylaxis for EUS Guided FNA of Pancreatic Cystic Lesions

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 10, 2014
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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