N/A
N=26
A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration
Pancreatic Cysts
Bottom Line
View on ClinicalTrials.gov: NCT01929460 ↗Enrolled (actual)
26
Serious AEs
3.9%
Results posted
Dec 2015
Primary outcome: Primary: Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ciprofloxacin (Drug); Placebo (for ciprofloxacin) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kaiser Permanente
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration |
0; 0 | — |
| PRIMARY Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration |
0; 0 | — |
| PRIMARY Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration |
0; 0 | — |
| SECONDARY Adverse Drug Reactions |
0; 0 | — |
| SECONDARY Procedure-related Complications |
0; 5 | — |
| SECONDARY Mean Cyst Fluid Carcinoembryonic Antigen (CEA) |
214.1; 2466.2 | — |
| SECONDARY Mean Cyst Fluid Amylase |
3729; 1944.5 | — |
| SECONDARY Median Cyst Fluid Carcinoembryonic Antigen (CEA) |
15; 24.9 | — |
| SECONDARY Median Cyst Fluid Amylase |
4006.5; 239 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01929460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.