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Completed

NCT Number: NCT04774198

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.

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Key information

Conditions

Pancreas Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood sample

Diagnostic Test

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 1, 2021
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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