Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreas Cancer
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Number of patients with persistent postoperative hypotension (<65 mmHg) after surgery
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eske Kvanner Aasvang
Clinical Professor
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Scheduled for PD on the suspicion of pancreatic cancer
- •Patients able to follow standardised surgical procedure including TIVA anaesthesia with epidural
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Number of patients with persistent postoperative hypotension (<65 mmHg) after surgery
Time Frame: 24 hours
Need for vasopressor infusion (noradrenaline) to maintain middle arterial blood pressure \>65 mmHg, the morning after pancreaticoduodenectomy.
Secondary Outcomes
- 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 severe clinical intra- and postoperative complications(30 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)