A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration

N/ACompletedNCT01929460

Kaiser Permanente26 enrolled

Overview

Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst aspiration is equally effective to the usual regimen of 3 days of post-procedural antibiotics.

With the increased use of cross sectional imaging, there appears to be an increasing prevalence of pancreatic cysts being incidentally discovered. A critical step in the workup of pancreas cysts is to determine whether the cyst is mucinous or non-mucinous, through a procedure called endoscopic ultrasound - fine needle aspiration (EUS-FNA). Current guidelines suggest the use of antibiotics in cyst aspiration, usually 3 days after the procedure. However, these recommendations are based on limited data from over 15 years ago. More recent retrospective observations suggest equivalent safety when little, or even no antibiotics are given.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pancreatic Cysts

Interventions

CiprofloxacinDRUG

ciprofloxacin oral capsule (one capsule twice a day for 3 days)

Placebo (for ciprofloxacin)OTHER

oral placebo capsule (one capsule twice a day for 3 days)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients between the age of 18-90 who present for an EUS / pancreas cyst evaluation Exclusion Criteria: * Patients outside the age range * Patient-related factors (unable to provide consent, unable to understand English, allergic to cipro) * High-risk patients for infective endocarditis * Bacterial infection or use of antibiotics within 6 weeks of EUS * Pancreatitis within the past 6 months * Underlying immunosuppression (for example, uncontrolled diabetes - such as hemoglobin A1c above 7 or glucose \> 180; renal failure; cirrhosis; pre-existing malignancy especially hematologic malignancy such as leukemia / lymphoma / multiple myeloma; HIV/AIDS) * Currently taking immunosuppressive medications (for conditions such as rheumatoid arthritis, inflammatory bowel disease, organ transplant) * Radiographic or endosonographic evidence of cyst cavity debris / necrotic debris * Severe systemic disease (for example, NYHA class III or IV heart failure, oxygen-dependent COPD)

Locations (1)

Kaiser Permanente, Los Angeles Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration

first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)

Time frame: At 2 weeks after procedure

Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration

second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)

Time frame: At 4 weeks after procedure

Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration

third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)

Time frame: At 6 weeks after procedure

Secondary Outcomes

Adverse Drug Reactions

Number of participants with adverse drug reactions

Time frame: six weeks

Procedure-related Complications

Number of patients with procedure-related complications

Time frame: six weeks after procedure

Mean Cyst Fluid Carcinoembryonic Antigen (CEA)

Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions

Time frame: six weeks

Mean Cyst Fluid Amylase

Mean cyst fluid amylase for classification of mucinous cystic lesions

Time frame: six weeks

Data from ClinicalTrials.gov

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