Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Participants With Surgical Site Infections
研究概览
简要总结
This trial evaluates whether testing of bile with nanopore sequencing results in earlier detection of bacteriobilia (bacteria in bile) that may lead to surgical site infections in patients undergoing surgery for benign or malignant pancreatic tumors. Surgical site infections are a significant source of poor outcomes in patients undergoing surgery for pancreatic tumors. In most patients who develop this kind of infection, the bacteria identified as causing the infection is also frequently found to be in the bile at time of surgery. Usage of nanopore sequencing for detection of bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.
详细描述
PRIMARY OBJECTIVE:
I. To improve antibiotic stewardship (reducing duration of peri-operative prophylactic antibiotic regimen, reducing administration of broad-spectrum antibiotic) by providing surgical team with rapid Oxford Nanopore (ONT) sequencing data in the early post-operative setting.
SECONDARY OBJECTIVE:
I. To reduce the cost of care through reduction in surgical site infection (SSI) and improved antibiotic stewardship.
OUTLINE: Patients are randomized to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 year (yr) male (M) or female (F)
- •Undergoing pancreaticoduodenectomy or total pancreatectomy for any benign or malignant indication with informed consent
排除标准
- •Women who are pregnant
- •Patients who are institutionalized or incarcerated
- •Patients without the cognitive capacity to consent
- •Patients undergoing emergency pancreaticoduodenectomy or total pancreatectomy
- •Patients enrolled in similar clinical trials involving use of perioperative antibiotics
结局指标
主要结局
Number of Participants With Surgical Site Infections
时间窗: Up to 90 days
Assessed by incidence of surgical site infections (SSI), classified using American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) definitions. Diagnostics tests to evaluate for SSI included physical examination, laboratory testing, and imaging such as computed tomography (CT) and ultrasound (US). Patients with complicated hospital courses returned for clinical visit after approximately 2 weeks with cross sectional CT imaging and laboratory testing with further follow up visits as clinically indicated. In the instance of an uneventful hospital course, patients returned at 4 weeks from their date of discharge for a clinical visit with CT imaging and laboratory testing. After this first routine follow-up appointment with surgery, patients continued to follow with medical oncology and with the surgical clinic on an as needed basis.
Improved Antibiotic Stewardship - Number of Antibiotics
时间窗: Up to 90 days
Assessed by the total number of antibiotics administered.
Improved Antibiotic Stewardship - Duration
时间窗: Up to 90 days
Assessed by the number of days patients were on antibiotics.
次要结局
- Timeliness of Sample Analysis(Up to 90 days)