Aubrey C. Swilling, DO, MS
Resident Physician
Department of Surgery, University of Kansas Medical Center
Kansas City, Missouri, United States
Kenda Eberhardt, MA
Senior Clinical Research Coordinator
University of Kansas Cancer Center
Kansas City, Kansas, United States
Benjamin M. Martin, MD FACS FACRS
Assistant Professor of Surgery
Department of Surgery, University of Kansas Medical Center
Kansas City, Kansas, United States
Mazin Al-Kasspooles, MD
Professor of Surgery
Department of Surgery, University of Kansas Medical Center
Kansas City, Kansas, United States
John H. Ashcraft, DO FACS FASCRS
Associate Professor of Surgery
Department of Surgery, University of Kansas Medical Center
Kansas City, Kansas, United States
Sam Luka, MD FACS FASCRS
Assistant Professor of Surgery
Department of Surgery, University of Kansas Medical Center
Kansas City, Kansas, United States
Anup Kasi, MD MPH
Associate Professor of Medicine
Department of Medicine, Division of Medical Oncology, University of Kansas Medical Center
Kansas City, Kansas, United States
Badal Roy, PhD
Senior Scientist
Department of Surgery, University of Kansas Medical Center
Kansas City, Kansas, United States
Nadine Santana-Magal, PhD
University of Kansas Medical Center
Kansas City, Kansas, United States
Debolina Dasgupta, MS
Graduate Student
Department of Cancer Biology, University of Kansas Medical Center
Kansas City, Kansas, United States
Debbie Fernandez, LMLP, MHSA, CPHQ
Director of quality, Oncology Service Line
University of Kansas Cancer Center
Kansas City, Kansas, United States
Marc S. Hoffmann, MD
Associate Professor of Medicine
Department of Medicine, Division of Medical Oncology, University of Kansas Medical Center
Kansas City, Kansas, United States
Lexie Brown, PhD
Assistant Research Professor
Department of Biostatistics, University of Kansas Medical Center
Kansas City, Kansas, United States
Kalyani Pyaram, PhD
Assistant Professor
Department of Cancer Biology, University of Kansas Medical Center
Kansas City, Kansas, United States
Shahid Umar, PhD
Professor of Surgery
Department of Surgery, University of Kansas Medical Center
Kansas City, Kansas, United States
Erin Plaza, MD
Associate Professor of Anesthesiology
Department of Anesthesiology, University of Kansas Medical Center
Kansas City, Kansas, United States
Luke V. Selby, MD MS FACS FSSO
Assistant Professor of Surgery
University of Kansas Medical Center
Leawood, Kansas, United States
Surgery is required for cure of most solid tumors, and general anesthesia is often required for most surgery. General anesthesia can be delivered through two broad approaches: volatile inhalational anesthesia (IA) or propofol-based total intravenous anesthesia (TIVA). Of these, IA is the most common, but is associated with worse post-operative recovery, post-operative immune dysregulation, earlier cancer recurrence and worse overall survival. Multiple randomized controlled trials have demonstrated that TIVA improves short-term post-operative recovery, but few of these studies have included translational outcomes. In vitro, propofol is known to inhibit the formation of neutrophil extracellular traps (NETs) that increase post-operatively and are associated with tumor recurrence. In spite of a biologic rationale for improved cancer outcomes, and studies showing improved clinical outcomes, it is estimated that TIVA is used in less than 10% of eligible cases nationally. Some opposition to TIVA is that it is believed to be more difficult to administer, but to our knowledge this has never been comprehensively evaluated.
Methods:
The VIVA trial (NCT06017141) is a prospective randomized trial in patients with primary resectable colon or upper rectal adenocarcinoma. Following exclusions for preexisting autoimmune conditions or a personal or family history of malignant hyperthermia, patients (n=80) with non-metastatic colon or upper rectal adenocarcinoma receiving upfront surgery are randomized 1:1 to TIVA or IA. Immune dysregulation is measured by changes in NET formation (the primary outcome) and changes in immune cell populations using flow cytometry. Differential RNA and protein expression are measured in resected tumor and adjuvant normal colon. Clinical recovery from surgery is measured broadly, including with patient reported outcome measures (the Quality of Recovery-40 and the Saint Louis Mental Status Exam), post-operative nausea and vomiting, opioid use, pain scores, and length of stay. In a subset of cases, anesthesia delivery will be directly observed to compare the required interventions while delivering TIVA and IA and then correlated with EHR recorded anesthetic dose adjustments for the full cohort to assess the relative difficulty of delivering TIVA vs IA. The VIVA trial (NCT06017141) has finished patient enrollment. It is anticipated the final patients will undergo surgery in October 2025 with primary data collection and patient unblinding occurring six months post-operatively.