NCT04774198

Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-12-07
• Completion: 2024-01-07
• First posted: 2021-03-01
• Last updated: 2025-04-06

Locations

1 site across 1 country: Denmark