Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy

NCT04774198 | Completed

• 1 other identifier: H-17024315
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of patients with infection

  30 days

• Number of patients with occurrence (yes/no) of systemic inflammatory response syndrome (SIRS) at any time during the first 30 days

  30 days

• Number of patients with severe clinical intra- and postoperatove complications

  30 days

• Number of patients with severe clinical intra- and postoperative complications

  30 days

• Number of patients with severe perioperative physiological deviations

  30 days

Study Arms (2)

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

Interventions

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)

No occurrence of persistent postoperative hypotension; Occurrence of persistent postoperative hypotension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Scheduled for PD on the suspicion of pancreatic cancer
• Patients able to follow standardised surgical procedure including TIVA anaesthesia with epidural

You may not qualify if:

• 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)
• ongoing treatment with glucocortocoid, anti-tnf-alpha etc.
• patients diagnosed with rheumatological diseases, IBD or chronic infection (eg. HIV)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Full blood

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Eske K Aasvang, DMSci

  Rigshospitalet, Denmark

  STUDY CHAIR

• Sisse R Ostrowski, DMSci

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: March 1, 2021
• Study Start: February 1, 2021
• Primary Completion: December 7, 2023
• Study Completion: January 7, 2024
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

DK (1)