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

Overview

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 Title of Study: “A Prospective, Placebo-controlled Trial on the Use of Antibiotics for Pancreatic Cyst Aspiration: a Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2014

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

  • Drug: Ciprofloxacin
    • ciprofloxacin oral capsule (one capsule twice a day for 3 days)
  • Other: Placebo (for ciprofloxacin)
    • oral placebo capsule (one capsule twice a day for 3 days)

Arms, Groups and Cohorts

  • Other: 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.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
    • Time Frame: At 2 weeks after procedure
    • first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
  • Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
    • Time Frame: At 4 weeks after procedure
    • second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
  • Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
    • Time Frame: At 6 weeks after procedure
    • third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)

Secondary Measures

  • Adverse Drug Reactions
    • Time Frame: six weeks
    • Number of participants with adverse drug reactions
  • Procedure-related Complications
    • Time Frame: six weeks after procedure
    • Number of patients with procedure-related complications
  • Mean Cyst Fluid Carcinoembryonic Antigen (CEA)
    • Time Frame: six weeks
    • Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions
  • Mean Cyst Fluid Amylase
    • Time Frame: six weeks
    • Mean cyst fluid amylase for classification of mucinous cystic lesions
  • Median Cyst Fluid Carcinoembryonic Antigen (CEA)
    • Time Frame: six weeks
    • Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions
  • Median Cyst Fluid Amylase
    • Time Frame: six weeks
    • Median cyst fluid amylase for classification of mucinous cystic lesions

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kaiser Permanente
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Karl Kwok, MD, Principal Investigator, Principal Investigator

References

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.

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.

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