Colonization of Bile Ducts and Post-operative Infectious Complications of Cephalic Duodenopancreatectomy : A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Comparison of preoperative Bile and postoperative infection sites microbiology results
研究概览
简要总结
Cephalic duodenopancreatectomy is part of the curative treatment for pancreatic cancer of the head and peri-ampullary area. The mortality of the procedure is around 5%, with a morbidity ranging from 30 to 50%. Infectious complications account for 35% of overall morbidity.
One of the risk factors for postoperative complications is the existence of preoperative retentional jaundice, due to tumoral obstruction of the main bile duct In these cases, it is proposed to perform preoperative bile duct drainage, preferably by endoscopic stenting (ERCP).
However, several studies have shown these procedures to cause biliary contamination which could be responsible for an increase in post-operative morbidity such as infectious complications and increased length of stay in hospital..
Thus, the biliary microbial flora is more often multi-microbial and may contain multidrug-resistant nosocomial germs,
The study carried out by Cortes et al., based on a control case study design, also showed that a correlation between biliary colonization and postoperative infectious complications existed in patients who benefited from a preoperative biliary drainage technique. In fact, the bacteria isolated during intraoperative bile sampling were similar, in 49% of cases, to those isolated during bacteriological samples collected postoperatively during infectious complications.
The work carried out by Krüger and al has shown that the spectrum of bacteria found in the preoperative bile samples from patients who have undergone bile duct dilation is potentially not covered by standard antibiotic therapy.
The aim of this observational prospective study is to investigate this correlation between biliary colonization and postoperative infectious complications, to evaluate the morbidity and postoperative mortality of cephalic duodenopancreatectomies performed at the CHRU of Nancy and to study a possible adaptation of perioperative antibiotic prophylaxis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > 18 years
- •Patient operated for a planned cephalic duodenopancreatectomy
- •Post-operative hospitalisation in ICU
- •Information leaflet given to the patient and the support person, with oral information, during the post-operative period
排除标准
- •Age < 18 years
- •Emergency duodenopancreatectomy (surgical indication period less than 48 hours)
结局指标
主要结局
Comparison of preoperative Bile and postoperative infection sites microbiology results
时间窗: from date of initial bile sample up to 30 days of postoperative period
bacterial count in log10 bacteria/ml and identification
次要结局
- Description of nutrition assistance(from date of initial bile sample up to 30 days of postoperative period)
- mortality rate(At day +28 and day +90)
- Impact of prior biliary drainage on the intraoperative bile microbiological results bacteriological results obtained(from date of initial bile sampling to date of surgery (up to 90 days))
- Microbial flora in clinical specimens obtained from different sites(from date of initial bile sample up to 90 postoperative days)
- Non infectious surgical complications using scores(from date of surgery up to 30 postoperative days)
- postoperative infectious complications as defined by the Centers for Disease Control and Prevention (Atlanta, Ga)(During hospital stay (up to 90 days after surgery))
- Implication of bacteria found in biliculture as causative agent in post-operative infections(During hospital stay (up to 90 days after surg)
- length of stay in intensive care and hospital(During the ICU stay and hospital)
- Nutritional status measured by nutritional risk index (NRI)(preoperative)