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OpenTrials
Completed

NCT Number: NCT01929460

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente, Los Angeles Medical Center

Los Angeles, California, 90027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ciprofloxacin

Drug

ciprofloxacin oral capsule (one capsule twice a day for 3 days)

Other names: Cipro

Placebo (for ciprofloxacin)

Other

oral placebo capsule (one capsule twice a day for 3 days)

Other names: sugar pill formulated to mimic oral ciprofloxacin

Primary outcomes

  1. 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)

  2. 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)

  3. 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 outcomes

  1. Adverse Drug Reactions

    Time frame: six weeks

    Number of participants with adverse drug reactions

  2. Procedure-related Complications

    Time frame: six weeks after procedure

    Number of patients with procedure-related complications

  3. Mean Cyst Fluid Carcinoembryonic Antigen (CEA)

    Time frame: six weeks

    Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions

  4. Mean Cyst Fluid Amylase

    Time frame: six weeks

    Mean cyst fluid amylase for classification of mucinous cystic lesions

  5. Median Cyst Fluid Carcinoembryonic Antigen (CEA)

    Time frame: six weeks

    Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions

  6. Median Cyst Fluid Amylase

    Time frame: six weeks

    Median cyst fluid amylase for classification of mucinous cystic lesions

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 28, 2013
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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