Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy

Pancreas Cancer Clinical Trial

Official title:

Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04774198
• Other study ID #: H-17024315
• Status: Active, not recruiting
• Start date: February 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: September 1, 2024
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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)

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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