Status:

COMPLETED

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

Lead Sponsor:

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

Collaborating Sponsors:

Spanish Clinical Research Network - SCReN

Conditions:

Pancreatic Cystic Lesion

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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.

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2018

Estimated Enrollment :

226 Patients enrolled

Trial Details

Trial ID

NCT02261896

Start Date

October 1 2014

End Date

July 1 2018

Last Update

April 12 2019

Active Locations (1)

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1

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08025