Article ; Online: Hepato
2024 Volume 14, Issue 4, Page(s) e072159
Abstract: Introduction: Surgical stress results in immune dysfunction, predisposing patients to infections in the postoperative period and potentially increasing the risk of cancer recurrence. Perioperative immunonutrition with arginine-enhanced diets has been ... ...
Abstract | Introduction: Surgical stress results in immune dysfunction, predisposing patients to infections in the postoperative period and potentially increasing the risk of cancer recurrence. Perioperative immunonutrition with arginine-enhanced diets has been found to potentially improve short-term and cancer outcomes. This study seeks to measure the impact of perioperative immunomodulation on biomarkers of the immune response and perioperative outcomes following hepatopancreaticobiliary surgery. Methods and analysis: This is a 1:1:1 randomised, controlled and blinded superiority trial of 45 patients. Baseline and perioperative variables were collected to evaluate immune function, clinical outcomes and feasibility outcomes. The primary outcome is a reduction in natural killer cell killing as measured on postoperative day 1 compared with baseline between the control and experimental cohorts. Ethics and dissemination: This trial has been approved by the research ethics boards at participating sites and Health Canada (parent control number: 223646). Results will be distributed widely through local and international meetings, presentation, publication and ClinicalTrials.gov (identifier: NCT04549662). Any modifications to the protocol will be communicated via publications and ClinicalTrials.gov. Trial registration number: ClinicalTrials.gov identifier: NCT04549662. |
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MeSH term(s) | Humans ; Neoplasms ; Research Design ; Immunomodulation ; Immunity ; Canada ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase II as Topic |
Language | English |
Publishing date | 2024-04-05 |
Publishing country | England |
Document type | Clinical Trial Protocol ; Journal Article |
ZDB-ID | 2599832-8 |
ISSN | 2044-6055 ; 2044-6055 |
ISSN (online) | 2044-6055 |
ISSN | 2044-6055 |
DOI | 10.1136/bmjopen-2023-072159 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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