A Prospective, Placebo-controlled Trial on the Use of Antibiotics for Pancreatic Cyst Aspiration: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the age of 18-90 who present for an EUS / pancreas cyst evaluation
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Ciprofloxacin (Drug)
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.
干预措施: Placebo (for ciprofloxacin) (Other)
结局指标
主要结局
Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
时间窗: At 6 weeks after procedure
third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
次要结局
- Adverse Drug Reactions(six weeks)
- Procedure-related Complications(six weeks after procedure)
- Mean Cyst Fluid Carcinoembryonic Antigen (CEA)(six weeks)
- Mean Cyst Fluid Amylase(six weeks)
- Median Cyst Fluid Carcinoembryonic Antigen (CEA)(six weeks)
- Median Cyst Fluid Amylase(six weeks)