Kaiser Permanente, Los Angeles Medical Center
Los Angeles, California, 90027, United States
NCT Number: NCT01929460
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.
Looking for future studies?
Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90027, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ciprofloxacin oral capsule (one capsule twice a day for 3 days)
Other names: Cipro
oral placebo capsule (one capsule twice a day for 3 days)
Other names: sugar pill formulated to mimic oral ciprofloxacin
Time frame: At 2 weeks after procedure
first time point (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)
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)
Time frame: six weeks
Number of participants with adverse drug reactions
Time frame: six weeks after procedure
Number of patients with procedure-related complications
Time frame: six weeks
Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions
Time frame: six weeks
Mean cyst fluid amylase for classification of mucinous cystic lesions
Time frame: six weeks
Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions
Time frame: six weeks
Median cyst fluid amylase for classification of mucinous cystic lesions
Kaiser Permanente
Other
A Prospective, Placebo-controlled Trial on the Use of Antibiotics for Pancreatic Cyst Aspiration: a Pilot Study
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.
Published trials that share one or more normalized conditions with this study.
NCT02110498
Cystic, Mucinous and/or Serous Neoplasm, Cysts
Baltimore, Maryland, United States
View Trial DetailsNCT01202136
Cysts, Digestive System Diseases
Baltimore, Maryland, United States
View Trial DetailsNCT04400357
Adenocarcinoma, Ampullary Adenocarcinoma
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT07034495
Adenocarcinoma, Benign Liver Tumors
Taichung, Taiwan
View Trial Details