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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Intervention group	Placebo (for ciprofloxacin)	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.
Drug (Standard group)	Ciprofloxacin	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration	At 6 weeks after procedure	third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)

Secondary Outcome Measures

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