A Pilot Study On The Use Of Prophylactic Antibiotics For EUS-guided Pancreatic Cyst Aspiration

Study Overview

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.

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.

Pancreatic Cysts

DRUG: Ciprofloxacin
OTHER: Placebo (for ciprofloxacin)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-08-13	Results First Submitted 2015-10-07	Last Update Submitted that met QC Criteria 2016-01-13
First Submitted that Met QC Criteria 2013-08-22	Results First Submitted that Met QC Criteria 2015-11-25	Last Update Posted (ESTIMATED) 2016-02-15
First Posted (ESTIMATED) 2013-08-28	Results First Posted 2015-12-31	Last Verified 2016-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

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)
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)

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)

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)

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients between the age of 18-90 who present for an EUS / pancreas cyst evaluation

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Karl Kwok, MD, Principal Investigator

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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.

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