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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-07-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Pancreatic Cystic Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

1 intravenous dose followed by 1 oral dose each 12 hours (complete 3 days)

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Evaluate usefullness of antibiotic prophylaxis

Antibiotic

Ciprofloxacin 400 mg intravenous one dose followed by ciprofloxacin 500 mg oral each 12 hours (complete 3 days)

Group Type ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type DRUG

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

Interventions

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Placebo

Evaluate usefullness of antibiotic prophylaxis

Intervention Type DRUG

Ciprofloxacin

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

Intervention Type DRUG

Eligibility 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No