Clinical trial · Observational
Perioperative Immune Function and Clinical Complications in Pancreaduodenectomy
NCT04774198CI-TRIAL-00114565completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sample | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Diagnostic Test: blood sample
- label
- 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.
- interventionNames
- Diagnostic Test: blood sample
Primary outcomes (1)
- measure
- Number of patients with persistent postoperative hypotension (<65 mmHg) after surgery
- timeFrame
- 24 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.