Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer (MIcRobiome Analysis in Patients UnderGoing PancrEatico-duodenectomy for Pancreatic Cancer MIRAGE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Structure of the gut microbiome
研究概览
简要总结
Pancreatic head cancer represents one of the most frequent malignancies with an incidence of about 13500 new cases each year. The primary objective of the study is to test whether there are bacterial species associated with increased risk of complications in patients with peri-ampullary neoplasia undergoing DCP.
详细描述
Pancreatic head cancer represents one of the most frequent malignancies with an incidence of about 13500 new cases each year. The only curative strategy for such neoplasm is still surgical resection by duodenocephalopancreasectomy (DCP) surgery. However, this procedure has a postoperative morbidity of about 70% with a severe complication rate of 20%. The most frequent complications are pancreatic fistula, biliary fistula, and infectious complications in general. These complications often account for a high postoperative mortality rate that even in high-volume centers reaches 5%. Although some predictive risk factors are known (comorbidities and the patient's age, the consistency of the pancreatic stump to be anastomized and/or type of pathology treated), there is still no study that has evaluated the influence of the gut microbiota in the determinism of complications. This hypothesis appears suggestive and supported by indirect evidence from the literature. Some preliminary studies performed in the field of colo-rectal surgery have shown that the presence of certain bacterial families such as Lachnospiraceae or Bacteroidaceae are correlated with a significant increase in anastomotic dehiscence. Low microbial diversity also appears to be correlated with increased risk of anastomotic dehiscence. In contrast, the presence of other species such as Prevotella copri or Streptococcus genus seem to correlate with a reduced risk of dehiscence.
The primary objective of the study is: to test whether there are bacterial species associated with increased risk of complications in patients with peri-ampullary neoplasia undergoing DCP.
Other objectives to be verified are:
- the association between bacterial species and the occurrence of pancreatic fistula in terms of frequency and severity
- the association between bacterial species and the occurrence of biliary fistula in terms of frequency and severity
- the association between bacterial species and the occurrence of infectious complications of any kind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age ≥18 years
- •Diagnosis of resectable pancreatic adenocarcinoma with indication for "upfront" surgical treatment
- •ASA (American Society of Anesthesiology) score < 4
- •Obtaining informed consent
排除标准
- •Pregnant or lactating women
结局指标
主要结局
Structure of the gut microbiome
时间窗: 7 days before surgery, 15 and 30 days after surgery thereafter
The structure of the gut microbiome will be characterized on the samples by "next-generation sequencing" of the hypervariable region V3 to V4 of the 16S rRNA gene (bacterial component) and by "shotgun genomics"; ecosystem functionality will be assessed by measuring the fecal concentration of short-chain fatty acids (SCFA).
次要结局
未报告次要终点