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

Kaiser Permanente

Status: Completed

Conditions: Pancreatic Cysts

Treatments: Drug: Ciprofloxacin; Other: Placebo (for ciprofloxacin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01929460

1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

Drug (Standard group)

Other group

Description:

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.

Treatment:

Drug: Ciprofloxacin

Intervention group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo (for ciprofloxacin)