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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Kaiser Permanente
Sponsor:
Information provided by (Responsible Party):
Karl Kwok, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01929460
First received: August 13, 2013
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Pancreatic Cysts
Drug: Ciprofloxacin
Other: Placebo (for ciprofloxacin)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective, Placebo-controlled Trial on the Use of Antibiotics for Pancreatic Cyst Aspiration: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration [ Time Frame: At 2 weeks after procedure ] [ Designated as safety issue: No ]
    first time point

  • Number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration [ Time Frame: At 4 weeks after procedure ] [ Designated as safety issue: No ]
    second time point

  • Number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration [ Time Frame: At 6 weeks after procedure ] [ Designated as safety issue: No ]
    third and final time point


Secondary Outcome Measures:
  • Secondary outcomes [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    1. adverse drug reactions

  • secondary outcome [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    2. procedure-related complications

  • secondary outcome [ Time Frame: six weeks ] [ Designated as safety issue: No ]
    3. performance of cyst fluid markers for classification of mucinous cystic lesions


Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: Ciprofloxacin
Other Name: Cipro
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.

Other: Placebo (for ciprofloxacin)
Other Name: sugar pill formulated to mimic oral ciprofloxacin

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929460

Contacts
Contact: Karl Kwok, MD 323-783-6830 stephanie.x.tovar@kp.org

Locations
United States, California
Kaiser Permanente, Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Contact: Karl Kwok, MD    323-783-6830    stephanie.x.tovar@kp.org   
Sponsors and Collaborators
Kaiser Permanente
  More Information

Publications:
Responsible Party: Karl Kwok, MD, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01929460     History of Changes
Other Study ID Numbers: 1
Study First Received: August 13, 2013
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Ciprofloxacin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014