Clinical trial NCT01929460: A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration
Official title: A Prospective, Placebo-controlled Trial on the Use of Antibiotics for Pancreatic Cyst Aspiration: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cysts
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
timeFrame: At 2 weeks after procedure
measure: Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
timeFrame: At 4 weeks after procedure
measure: Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
timeFrame: At 6 weeks after procedure
Secondary outcomes:
measure: Adverse Drug Reactions
timeFrame: six weeks
measure: Procedure-related Complications
timeFrame: six weeks after procedure
measure: Mean Cyst Fluid Carcinoembryonic Antigen (CEA)
timeFrame: six weeks
measure: Mean Cyst Fluid Amylase
timeFrame: six weeks
measure: Median Cyst Fluid Carcinoembryonic Antigen (CEA)
timeFrame: six weeks
measure: Median Cyst Fluid Amylase
timeFrame: six weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente, Los Angeles Medical Center
state: California
Study officials:
affiliation: Principal Investigator
name: Karl Kwok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.