Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Number of patients with persistent postoperative hypotension (<65 mmHg) after surgery
研究概览
简要总结
Perioperative immunologic signatures can predict the risk of postoperative complications.
The results will be puplished as two smanuscripts. The manuscript will focus on preoperative immunologisk data,the second manuscript will include both pre- and postoperative data.
详细描述
OBJECTIVE Establish evidence for perioperative immunologic risk stratification of patient's risk for clinically postoperative inflammatory complications as a basis for future mechanism-based intervention studies.
Combining detailed immune assessment from cell-receptors to cell expression, cytokines, and complications with a temporal aspect is innovative and provides highly warranted novel multidimensional immunological insight.
METHODS Adult patients scheduled for PD on the suspicion of pancreatic cancer excluding patients receiving immunomodulating treatment 1 month properatively and/or autoimmune diseases. Patients scheduled for simultaneous procedures on major blood vessels, and/or adjacent organs (spleen, liver) are also not included. Inoperable patients, for instance, due to carcinosis, circulatory/ventilatory instability hindering procedure completion and/or concomitant surgery on major blood vessels, spleen, or liver, are excluded post-inclusion and will not be part of the primary analysis. Patients eligible for inclusion will be identified before their appointment at the Gastrosurgical Dept., Rigshospitalet which is the largest DK and North-European center with about 200 PD/yr annually.
Primary outcome:
Persistent postoperative hypotension, defined as need for vassopressor infussion on the morning after surgery to maintain middle arterial bloodpressure >65 mmHg
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
- •Scheduled for PD on the suspicion of pancreatic cancer
- •Patients able to follow standardised surgical procedure including TIVA anaesthesia with epidural
排除标准
- •Bilirubin >100 µmol/ltr
- •Patients receiving immunomodulating treatment 1 month properatively and/or autoimmune diseases and patients non-cenacerous cystic lessions
- •Patients scheduled for simultaneous procedures on major arterial blood vessels, and/or adjacent organs (spleen, liver)
- •Inoperable patients, for instance, due to carcinosis, circulatory/ventilatory instability hindering procedure completion and/or concomitant surgery on major arterial blood vessels, spleen, or liver, are excluded post-inclusion and will not be part of the primary analysis
- •ongoing treatment with glucocortocoid, anti-tnf-alpha etc.
- •patients diagnosed with rheumatological diseases, IBD or chronic infection (eg. HIV)
研究组 & 干预措施
Occurrence of persistent postoperative hypotension
Patients with need for noradrenaline the morning after surgery to maintain middle arterial blood-pressure (MAP)>65 mmHg, after pancreaticoduodenectomy.
干预措施: blood sample (Diagnostic Test)
No occurrence of persistent postoperative hypotension
Patients without need for noradrenaline the morning after surgery to maintain middle arterial blood-pressure (MAP)>65 mmHg, after pancreaticoduodenectomy.
干预措施: blood sample (Diagnostic Test)
结局指标
主要结局
Number of patients with persistent postoperative hypotension (<65 mmHg) after surgery
时间窗: 24 hours
Need for vasopressor infusion (noradrenaline) to maintain middle arterial blood pressure \>65 mmHg, the morning after pancreaticoduodenectomy.
次要结局
- Number of patients with severe clinical intra- and postoperative complications(30 days)
- Number of patients with infection(30 days)
- Number of patients with severe perioperative physiological deviations(30 days)
- Number of patients with development of delirium after surgery(7 days)
- Number of patients with occurrence (yes/no) of systemic inflammatory response syndrome (SIRS) at any time during the first 30 days(30 days)
- Number of patients with severe clinical intra- and postoperatove complications(30 days)
研究者
Eske Kvanner Aasvang
Clinical Professor
Rigshospitalet, Denmark