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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cysts
• Intervention / Treatment: Drug: Ciprofloxacin; Other: Placebo (for 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente, Los Angeles Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Ciprofloxacin; ciprofloxacin oral capsule (one capsule twice a day for 3 days); Other Names: 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); oral placebo capsule (one capsule twice a day for 3 days); Other Names: sugar pill formulated to mimic oral ciprofloxacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Karl Kwok, MD, Principal Investigator

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (ESTIMATE): August 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 15, 2016
• Last Update Submitted That Met QC Criteria: January 13, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Pathological Conditions, Anatomical; Pancreatic Diseases; Pancreatic Cyst; Cysts; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 1