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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Placebo-controlled Trial on the Use of Antibiotics for Pancreatic Cyst Aspiration: a Pilot Study

Conditions
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Pancreatic Cysts

Intervention / Treatment
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* Drug: Ciprofloxacin
* Other: Placebo (for ciprofloxacin)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Drug (Standard group)<br>Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration. Ciprofloxacin 500mg by mouth twice a day for three days. | Drug: Ciprofloxacin<br>* ciprofloxacin oral capsule (one capsule twice a day for 3 days)<br>* Other names: Cipro;|
| Placebo Comparator: Intervention group<br>Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration Oral Placebo, one cap twice a day for three days. | Other: Placebo (for ciprofloxacin)<br>* oral placebo capsule (one capsule twice a day for 3 days)<br>* Other names: sugar pill formulated to mimic oral ciprofloxacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | At 6 weeks after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Reactions | Number of participants with adverse drug reactions | six weeks | 
| Procedure-related Complications | Number of patients with procedure-related complications | six weeks after procedure | 
| Mean Cyst Fluid Carcinoembryonic Antigen (CEA) | Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions | six weeks | 
| Mean Cyst Fluid Amylase | Mean cyst fluid amylase for classification of mucinous cystic lesions | six weeks | 
| Median Cyst Fluid Carcinoembryonic Antigen (CEA) | Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions | six weeks | 
| Median Cyst Fluid Amylase | Median cyst fluid amylase for classification of mucinous cystic lesions | six weeks |