NCT02261896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

3.8 years

First QC Date

October 7, 2014

Last Update Submit

April 10, 2019

Conditions

Pancreatic Cystic Lesion

Keywords

cystpancreatic cystEUS-FNAantibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Risk of infection of a pancreatic cyst or infection related to the procedure

    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.

    21 days

Secondary Outcomes (2)

  • Risk of fever

    21 days

  • secondary effects, allergic reactions, and drug resistant or secondary infections

    21 days

Study Arms (2)

Placebo

EXPERIMENTAL

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

Drug: Placebo

Antibiotic

ACTIVE COMPARATOR

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

Drug: Ciprofloxacin

Interventions

PlaceboDRUG

Evaluate usefullness of antibiotic prophylaxis

Placebo
CiprofloxacinDRUG

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

Antibiotic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (1)

  • Colan-Hernandez J, Sendino O, Loras C, Pardo A, Gornals JB, Concepcion M, Sanchez-Montes C, Murzi M, Andujar X, Velasquez-Rodriguez J, Rodriguez de Miguel C, Fernandez-Esparrach G, Gines A, Guarner-Argente C. Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial. Gastroenterology. 2020 May;158(6):1642-1649.e1. doi: 10.1053/j.gastro.2020.01.025. Epub 2020 Jan 20.

    PMID: 31972236DERIVED

MeSH Terms

Conditions

CystsPancreatic Cyst

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

NeoplasmsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Carlos Guarner-Argente, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 10, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

April 12, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)