Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Cysts

Pancreatic Cyst

Pathological Conditions, Anatomical

Pancreatic Diseases

Gastrointestinal Diseases

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Ciprofloxacin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Pancrelipase

Pancreatin

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

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.

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.

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

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

Placebo (for ciprofloxacin)

Karl Kwok, MD

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.

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

first time point (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)

third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)

Number of participants with adverse drug reactions

Number of patients with procedure-related complications

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

Mean cyst fluid amylase for classification of mucinous cystic lesions

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

Median cyst fluid amylase for classification of mucinous cystic lesions

Kaiser Permanente

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.

Ciprofloxacin

Drug (Standard 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.

Placebo (for ciprofloxacin)

Intervention Group

Ciprofloxacin (Standard Group)

Placebo (Intervention Group)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Number of fine needle aspiration (FNA) passes

Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration

Adverse Drug Reactions

Procedure-related Complications

Mean Cyst Fluid Carcinoembryonic Antigen (CEA)

Mean Cyst Fluid Amylase

Median Cyst Fluid Carcinoembryonic Antigen (CEA)

Median Cyst Fluid Amylase

Standard group: this group will receive three days of oral antibiotics after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration.

Ciprofloxacin 500mg by mouth twice a day for three days.

Ciprofloxacin

Intervention group: this group will receive three days of oral PLACEBO after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration

Oral Placebo, one cap twice a day for three days.

Placebo (for ciprofloxacin)

Spots Global Cancer Trial Database for placebo (for ciprofloxacin)