2021-02-01
2023-12-07
2024-01-07
48
NCT04774198
Rigshospitalet, Denmark
Rigshospitalet, Denmark
OBSERVATIONAL
Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy
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.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-01-31 | N/A | 2025-04-02 |
2021-02-25 | N/A | 2025-04-06 |
2021-03-01 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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. | DIAGNOSTIC_TEST: blood sample
|
| : 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. | DIAGNOSTIC_TEST: blood sample
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of patients with persistent postoperative hypotension (<65 mmHg) after surgery | Need for vasopressor infusion (noradrenaline) to maintain middle arterial blood pressure >65 mmHg, the morning after pancreaticoduodenectomy. | 24 hours |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of patients with infection | Ex. surgical site infection, pneumonia, sepsis, etc, based upon international criteria (eg. center for disease control) | 30 days |
| Number of patients with occurrence (yes/no) of systemic inflammatory response syndrome (SIRS) at any time during the first 30 days | SIRS defined as two or more of either of the following four criteria: i) temperature <36°C or >38°C, ii) heart rate >90/min., iii) respiratory rate >20/min and/or iv) white blood cell count (WBC) <4x109/L (<4000/mm³), >12x109/L (>12,000/mm³) or ≥10% bands neutrophils. | 30 days |
| Number of patients with severe clinical intra- and postoperatove complications | Complications assessed by Clavien-Dindo classification and Comprehensive Clinical complication Index (CCI) ( (i.e. anastomotic leakage, reoperation, thrombosis, bleeding, etc.) | 30 days |
| Number of patients with severe clinical intra- and postoperative complications | Complications assessed by SOFA score including single organ system deviation | 30 days |
| Number of patients with severe perioperative physiological deviations | Frequency og physiological deviation Monitored by WARD-clinical support system (i.e hypotension, desaturation, tachycardia, etc.). | 30 days |
| Number of patients with development of delirium after surgery | Development of delirium measured with the 3D-CAM score | 7 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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