Pancreatic Cysts
Conditions
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.
Interventions
DRUGCiprofloxacin
ciprofloxacin oral capsule (one capsule twice a day for 3 days)
OTHERPlacebo (for ciprofloxacin)
oral placebo capsule (one capsule twice a day for 3 days)
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration | At 2 weeks after procedure | first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Adverse Drug Reactions | six weeks | Number of participants with adverse drug reactions |
| 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 |
| Mean Cyst Fluid Amylase | six weeks | Mean cyst fluid amylase for classification of mucinous cystic lesions |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ciprofloxacin (Standard Group) 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.
Ciprofloxacin | 13 |
| Placebo (Intervention Group) 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.
Placebo (for ciprofloxacin) | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Ciprofloxacin (Standard Group) | Placebo (Intervention Group) | Total |
|---|---|---|---|
| Age, Continuous | 68 years | 68.5 years | 68.3 years |
| Number of fine needle aspiration (FNA) passes | 1.46 passes | 1.38 passes | 1.42 passes |
| Region of Enrollment United States | 13 participants | 13 participants | 26 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 4 / 13 |
| serious Total, serious adverse events | 0 / 13 | 1 / 13 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciprofloxacin (Standard Group) | Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration | 0 participants |
| Placebo (Intervention Group) | Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration | 0 participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciprofloxacin (Standard Group) | Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration | 0 participants |
| Placebo (Intervention Group) | Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration | 0 participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciprofloxacin (Standard Group) | Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration | 0 participants |
| Placebo (Intervention Group) | Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration | 0 participants |
Secondary
Adverse Drug Reactions
Number of participants with adverse drug reactions
Time frame: six weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciprofloxacin (Standard Group) | Adverse Drug Reactions | 0 participants |
| Placebo (Intervention Group) | Adverse Drug Reactions | 0 participants |
Secondary
Mean Cyst Fluid Amylase
Mean cyst fluid amylase for classification of mucinous cystic lesions
Time frame: six weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ciprofloxacin (Standard Group) | Mean Cyst Fluid Amylase | 3729 Units/L |
| Placebo (Intervention Group) | Mean Cyst Fluid Amylase | 1944.5 Units/L |
Secondary
Mean Cyst Fluid Carcinoembryonic Antigen (CEA)
Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions
Time frame: six weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ciprofloxacin (Standard Group) | Mean Cyst Fluid Carcinoembryonic Antigen (CEA) | 214.1 ng/mL |
| Placebo (Intervention Group) | Mean Cyst Fluid Carcinoembryonic Antigen (CEA) | 2466.2 ng/mL |
Secondary
Median Cyst Fluid Amylase
Median cyst fluid amylase for classification of mucinous cystic lesions
Time frame: six weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ciprofloxacin (Standard Group) | Median Cyst Fluid Amylase | 4006.5 Units/L |
| Placebo (Intervention Group) | Median Cyst Fluid Amylase | 239 Units/L |
Secondary
Median Cyst Fluid Carcinoembryonic Antigen (CEA)
Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions
Time frame: six weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ciprofloxacin (Standard Group) | Median Cyst Fluid Carcinoembryonic Antigen (CEA) | 15 ng/mL |
| Placebo (Intervention Group) | Median Cyst Fluid Carcinoembryonic Antigen (CEA) | 24.9 ng/mL |
Secondary
Procedure-related Complications
Number of patients with procedure-related complications
Time frame: six weeks after procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciprofloxacin (Standard Group) | Procedure-related Complications | 0 participants |
| Placebo (Intervention Group) | Procedure-related Complications | 5 participants |