Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy

Rigshospitalet

Status: Completed

Conditions: Pancreas Cancer

Treatments: Diagnostic Test: blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT04774198

H-17024315

Details and patient eligibility

About

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.

Full 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

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

48 participants in 2 patient groups

Occurrence of persistent postoperative hypotension

Description:

Patients with need for noradrenaline the morning after surgery to maintain middle arterial blood-pressure (MAP)\>65 mmHg, after pancreaticoduodenectomy.

Treatment:

Diagnostic Test: blood sample

No occurrence of persistent postoperative hypotension

Description:

Patients without need for noradrenaline the morning after surgery to maintain middle arterial blood-pressure (MAP)\>65 mmHg, after pancreaticoduodenectomy.

Treatment:

Diagnostic Test: blood sample