NCT01929460

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Pancreatic Cysts

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-08-28
• Last updated: 2016-02-15
• Results posted: 2015-12-31

Locations

1 site across 1 country: United States