Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy

Completed

• Conditions: Pancreas Cancer
• Interventions: Diagnostic Test: blood sample

• Registration Number: NCT04774198
• Lead Sponsor: Rigshospitalet, Denmark

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

Study Timeline

• Study First Submitted: 2021-01-31
• Study Start: 2021-02-01
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Primary Completion: 2023-12-07
• Study Completion: 2024-01-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No occurrence of persistent postoperative hypotension	blood sample	Patients without need for noradrenaline the morning after surgery to maintain middle arterial blood-pressure (MAP)\>65 mmHg, after pancreaticoduodenectomy.
Occurrence of persistent postoperative hypotension	blood sample	Patients with need for noradrenaline the morning after surgery to maintain middle arterial blood-pressure (MAP)\>65 mmHg, after pancreaticoduodenectomy.

Primary Outcome Measures

Name	Time	Method
Number of patients with persistent postoperative hypotension (<65 mmHg) after surgery	24 hours	Need for vasopressor infusion (noradrenaline) to maintain middle arterial blood pressure \>65 mmHg, the morning after pancreaticoduodenectomy.

Secondary Outcome Measures

Name	Time	Method
Number of patients with infection	30 days	Ex. surgical site infection, pneumonia, sepsis, etc, based upon international criteria (eg. center for disease control)
Number of patients with severe perioperative physiological deviations	30 days	Frequency og physiological deviation Monitored by WARD-clinical support system (i.e hypotension, desaturation, tachycardia, etc.).
Number of patients with development of delirium after surgery	7 days	Development of delirium measured with the 3D-CAM score
Number of patients with severe clinical intra- and postoperative complications	30 days	Complications assessed by SOFA score including single organ system deviation
Number of patients with occurrence (yes/no) of systemic inflammatory response syndrome (SIRS) at any time during the first 30 days	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.
Number of patients with severe clinical intra- and postoperatove complications	30 days	Complications assessed by Clavien-Dindo classification and Comprehensive Clinical complication Index (CCI) ( (i.e. anastomotic leakage, reoperation, thrombosis, bleeding, etc.)

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark