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Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy

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ClinicalTrials.gov Identifier: NCT04774198
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Eske Kvanner Aasvang, Rigshospitalet, Denmark

Study Description
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Brief Summary:
Perioperative immunologic signatures can predict the risk of postoperative complications.

Condition or disease Intervention/treatment
Pancreas Cancer Diagnostic Test: blood sample

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

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : August 1, 2022

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Groups and Cohorts
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Group/Cohort 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
Blood samples are collected within 24 hours before the surgical procedure, on postoperative day two and seven. Samples collected are as following: TruCulture, flow cytometry, markers of systemic inflammation (Plasma level of pro- and anti-inflammatory molecules assed by Olink inflammation panel, leucocytes, differential count, hemoglobin, thrombocytes and CRP)
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
Blood samples are collected within 24 hours before the surgical procedure, on postoperative day two and seven. Samples collected are as following: TruCulture, flow cytometry, markers of systemic inflammation (Plasma level of pro- and anti-inflammatory molecules assed by Olink inflammation panel, leucocytes, differential count, hemoglobin, thrombocytes and CRP)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of patients with infection [ Time Frame: 30 days ]
    Ex. surgical site infection, pneumonia, sepsis, etc, based upon international criteria (eg. center for disease control)

  2. Number of patients with occurrence (yes/no) of systemic inflammatory response syndrome (SIRS) at any time during the first 30 days [ Time Frame: 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.

  3. Number of patients with severe clinical intra- and postoperatove complications [ Time Frame: 30 days ]
    Complications assessed by Clavien-Dindo classification and Comprehensive Clinical complication Index (CCI) ( (i.e. anastomotic leakage, reoperation, thrombosis, bleeding, etc.)

  4. Number of patients with severe clinical intra- and postoperative complications [ Time Frame: 30 days ]
    Complications assessed by SOFA score including single organ system deviation

  5. Number of patients with severe perioperative physiological deviations [ Time Frame: 30 days ]
    Frequency og physiological deviation Monitored by WARD-clinical support system (i.e hypotension, desaturation, tachycardia, etc.).

  6. Number of patients with development of delirium after surgery [ Time Frame: 7 days ]
    Development of delirium measured with the 3D-CAM score


Biospecimen Retention:   Samples Without DNA
Full blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients scheduled for PD on the suspicion of pancreatic cancer excluding 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) are also not included. 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. Patients eligible for inclusion will be identified before their appointment.
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)
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774198


Contacts
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Contact: Sandra T Pitter, MD +4540309153 sandra_pitter@hotmail.com
Contact: Eske K Aasvang, DMSci 26232076 eske.kvanner.aasvang.01@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Sandra T Pitter, MD    +4540309153      
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Chair: Eske K Aasvang, DMSci Rigshospitalet, Denmark
Study Director: Sisse R Ostrowski, DMSci Rigshospitalet, Denmark
More Information
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Responsible Party: Eske Kvanner Aasvang, Clinical Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04774198    
Other Study ID Numbers: H-17024315
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases