Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug (Standard group) | Other | 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. |
|
| Intervention group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin | Drug | ciprofloxacin oral capsule (one capsule twice a day for 3 days) |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karl Kwok, MD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente, Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15758904 | Background | Jacobson BC, Baron TH, Adler DG, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; American Society for Gastrointestinal Endoscopy. ASGE guideline: The role of endoscopy in the diagnosis and the management of cystic lesions and inflammatory fluid collections of the pancreas. Gastrointest Endosc. 2005 Mar;61(3):363-70. doi: 10.1016/s0016-5107(04)02779-8. No abstract available. | |
| 15765442 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ciprofloxacin (Standard Group) | Standard group: this group will receive three days of oral antibiotics after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration. Ciprofloxacin 500mg by mouth twice a day for three days. Ciprofloxacin |
| FG001 | Placebo (Intervention Group) | Intervention group: this group will receive three days of oral PLACEBO after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration Oral Placebo, one cap twice a day for three days. Placebo (for ciprofloxacin) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo (Intervention Group) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | participants | At 2 weeks after procedure |
|
Adverse events were prospectively monitored during the study period (1/1/2014-12/31/2014) at 2, 4, 6 weeks post procedure, or if the patient contacted the on-call research staff at any time after hours.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Drug (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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pancreatitis | Gastrointestinal disorders | pancreatitis | Systematic Assessment | one patient in the placebo arm was admitted for post-procedure pancreatitis. Recovered without incident. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | Gastrointestinal disorders | pain | Systematic Assessment | 2 cases deemed unrelated to the procedure (1, nephrolithiasis; 1, chronic abdominal pain). 1 case deemed probably unrelated 1 case deemed possibly related but resolved uneventfully with conservative measures only |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karl Kwok, MD | Kaiser Permanente, Los Angeles Medical Center | 800-954-8000 | regional-research-committee@kp.org |
Not provided
| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo (for ciprofloxacin) | Other | oral placebo capsule (one capsule twice a day for 3 days) |
|
|
| 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 |
| Background |
| Lee LS, Saltzman JR, Bounds BC, Poneros JM, Brugge WR, Thompson CC. EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. Clin Gastroenterol Hepatol. 2005 Mar;3(3):231-6. doi: 10.1016/s1542-3565(04)00618-4. |
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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of fine needle aspiration (FNA) passes | Mean | Full Range | passes |
|
|
|
| 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) | Posted | Number | participants | At 4 weeks after procedure |
|
|
|
| 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) | Posted | Number | participants | At 6 weeks after procedure |
|
|
|
| Secondary | Adverse Drug Reactions | Number of participants with adverse drug reactions | Posted | Number | participants | six weeks |
|
|
|
| Secondary | Procedure-related Complications | Number of patients with procedure-related complications | Posted | Number | participants | six weeks after procedure |
|
|
|
| Secondary | Mean Cyst Fluid Carcinoembryonic Antigen (CEA) | Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions | Posted | Mean | Full Range | ng/mL | six weeks |
|
|
|
| Secondary | Mean Cyst Fluid Amylase | Mean cyst fluid amylase for classification of mucinous cystic lesions | Posted | Mean | Full Range | Units/L | six weeks |
|
|
|
| Secondary | Median Cyst Fluid Carcinoembryonic Antigen (CEA) | Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions | Posted | Median | Inter-Quartile Range | ng/mL | six weeks |
|
|
|
| Secondary | Median Cyst Fluid Amylase | Median cyst fluid amylase for classification of mucinous cystic lesions | Posted | Median | Inter-Quartile Range | Units/L | six weeks |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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) | 1 | 13 | 4 | 13 |
|
|
Not provided
Not provided
Not provided
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |