Surgery (Austin & Northern Health) - Research Publications
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ItemNo Preview AvailableSCORE: a randomised controlled trial evaluating shared care (general practitioner and oncologist) follow-up compared to usual oncologist follow-up for survivors of colorectal cancer(ELSEVIER, 2023-12)BACKGROUND: SCORE is the first randomised controlled trial (RCT) to examine shared oncologist and general practitioner (GP) follow-up for survivors of colorectal cancer (CRC). SCORE aimed to show that shared care (SC) was non-inferior to usual care (UC) on the EORTC QLQ-C30 Global Health Status/Quality of Life (GHQ-QoL) scale to 12 months. METHODS: The study recruited patients from five public hospitals in Melbourne, Australia between February 2017 and May 2021. Patients post curative intent treatment for stage I-III CRC underwent 1:1 randomisation to SC and UC. SC replaced two oncologist visits with GP visits and included a survivorship care plan and primary care management guidelines. Assessments were at baseline, 6 and 12 months. Difference between groups on GHQ-QoL to 12 months was estimated from a mixed model for repeated measures (MMRM), with a non-inferiority margin (NIM) of -10 points. Secondary endpoints included quality of life (QoL); patient perceptions of care; costs and clinical care processes (CEA tests, recurrences). Registration ACTRN12617000004369p. FINDINGS: 150 consenting patients were randomised to SC (N = 74) or UC (N = 76); 11 GPs declined. The mean (SD) GHQ-QoL scores at 12 months were 72 (20.2) for SC versus 73 (17.2) for UC. The MMRM mean estimate of GHQ-QoL across the 6 month and 12 month follow-up was 69 for SC and 73 for UC, mean difference -4.0 (95% CI: -9.0 to 0.9). The lower limit of the 95% CI did not cross the NIM. There was no clear evidence of differences on other QoL, unmet needs or satisfaction scales. At 12 months, the majority preferred SC (40/63; 63%) in the SC group, with equal preference for SC (22/62; 35%) and specialist care (22/62; 35%) in UC group. CEA completion was higher in SC. Recurrences similar between arms. Patients in SC on average incurred USD314 less in health costs versus UC patients. INTERPRETATION: SC seems to be an appropriate and cost-effective model of follow-up for CRC survivors. FUNDING: Victorian Cancer Agency and Cancer Australia.
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ItemNo Preview Available"Iodide mumps" after angioplasty(Elsevier, 2000-02-01)Vascular surgeons are increasingly performing endo- vascular fluoroscopy-guided procedures. We report a rare complication of radiographic contrast exposure (iodide-induced sialadenitis or “iodide mumps”), which has significance in the postoperative observation and management of patients after these procedures.
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ItemRadical nephrectomy with caval tumor thrombectomy: An Australian experience(Canadian Urological Association, 2022)Introduction: Inferior vena cava (IVC) tumor thrombus is seen in up to 10% of renal cell carcinoma (RCC) and greatly complicates surgical management. We aimed to assess perioperative morbidity and longterm oncological outcomes after radical nephrectomy with caval tumor thrombectomy. Methods: This was a retrospective review of radical nephrectomy with caval tumor thrombectomy from 2011–2021. Continuous variables were reported as median (range). Kaplan-Meier survival curves were compared using the log-rank test. Results: We identified 22 patients; 15 (68.2%) were male and the median age was 63.5 years (34–75). There were three (13.6%) level III and eight (36.4%) level IV tumor thrombi. RCC size was 11.2 cm (2.7–21.0), with 13 (59.1%) right-sided. Nine (40.9%) patients had metastatic disease. Operative time was nine hours (5–18.8); seven (31.8) cases were performed emergently and nine (40.9%) underwent cardiopulmonary bypass. One (4.5%) patient died intraoperatively and four (18.2%) died in-hospital. Length of stay was 12.5 days (5–66) and 9 (40.9%) patients experienced Clavien-Dindo IV complications. Nineteen (86.4%) tumors were of clear-cell variant and 17 (77.3%) had positive margins. Excluding in-hospital deaths, median followup was 20 months (4–65). Five (27.8%) patients received adjuvant therapy and cancer recurrence occurred in six (33.3%). Overall survival (OS) was 66.7% (n=12) over a duration of 17 months (4–65) and recurrence-free survival (RFS) was 50% (n=9) over seven months (4–65). Time-to-recurrence and time-to-death were 9.5 months (2–19) and 13.5 months (1–33), respectively. On survival analysis, there were significant differences in OS (p=0.006) and RFS (p=0.006) with regards to metastatic status. Tumor thrombus level showed a difference in RFS only (p=0.006). Cardiopulmonary bypass was not predictive of OS (p=0.54) or RFS (p=0.82). Conclusions: Although radical nephrectomy with caval tumor thrombectomy is associated with significant morbidity and mortality, it remains an effective procedure in the treatment of advanced RCC.
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ItemNo Preview AvailableEvaluating sex as a predictive marker for response to bevacizumab in metastatic colorectal carcinoma: Pooled analysis of 3,369 patients in the ARCAD database.(Elsevier BV, 2023-01)BACKGROUND: Previous studies suggest a possible sex-specific response to bevacizumab in metastatic colorectal carcinoma (mCRC), showing a benefit in males, while the effect in females is less significant. METHODS: Data from 3369 patients with mCRC enrolled on four first-line randomised trials testing chemotherapy with or without bevacizumab (2000-2007) were pooled. Association between sex and progression-free survival and overall survival (OS) was evaluated by stratified Cox regression model, adjusted for potential confounders. Predictive value was evaluated by interaction effect between sex and treatment. In a pre-planned secondary analysis, analyses were stratified using an age cut point of 60 years to evaluate the possible role of menopausal-related effects. RESULTS: Bevacizumab was associated with an improved median OS in males and females, with a 2.3- and 0.6-months benefit, respectively. Stratified by age, bevacizumab resulted in improved OS in males at both age categories. In females at or above the age of 60 (n = 731), bevacizumab resulted in improved OS. However, in females below the age of 60 (n = 634), OS benefit did not reach statistical significance (adjusted hazard ratio = 0.94, 95% confidence interval 0.74-1.20). CONCLUSIONS: Our results confirmed the OS benefit from the addition of bevacizumab to first-line chemotherapy in mCRC in both sexes. Among females, the benefit was less than 1 month. For females under the age of 60, there was no survival benefit. These findings could be used to relieve financial toxicity or be redistributed within healthcare systems for other health-related purposes.
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ItemNo Preview AvailableA novel two-stage approach to the treatment of renal cell carcinoma with intra-cardiac tumour extension and Budd-Chiari syndrome(WILEY, 2024-04)OBJECTIVE: To present the early results of a new technique for the treatment of renal cell carcinoma with intra-cardiac tumour extension and Budd-Chiari syndrome. PATIENTS AND METHODS: The first stage involves transdiaphragmatic debulking of the right heart, inferior vena cava (IVC) and hepatic veins via median sternotomy, followed by a purse-string suture placed in the IVC below the hepatic veins. The second stage is performed separately and involves en bloc resection of the affected kidney, and IVC and vascular reconstruction via an abdominal incision. RESULTS: Three of five patients presented with clinical Budd-Chiari syndrome; two had radiological features only. The median time between surgical procedures was 12 days (IQR 13 days). Four of the five patients had a R0 resection. While all five patients successfully completed both operative stages, one patient died 22 days after the second stage. Of the remaining four, all survive with no disease recurrence. CONCLUSION: While we continue to compile longer-term data for a larger follow-up series, these preliminary findings show the feasibility of this technique and support the development of this programme of surgery.
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ItemNo Preview AvailableBreaches of pre-medical emergency team call criteria in an Australian hospital(ELSEVIER, 2023-12)OBJECTIVES AND OUTCOMES: To evaluate the 24hrs before medical emergency team (MET) calls to examine: 1) the frequency, nature, and timing of pre-MET criteria breaches; 2) differences in characteristics and outcomes between patients who did and didn't experience pre-MET breaches. DESIGN: Retrospective observational study November 2020-June 2021. SETTING: Tertiary referral Australian hospital. PARTICIPANTS: Adults (≥18 years) experiencing MET calls. RESULTS: Breaches in pre-MET criteria occurred prior to 1886/2255 (83.6%) MET calls, and 1038/1281 (81.0%) of the first MET calls. Patients with pre-MET breaches were older (median [IQR] 72 [57-81] vs 66 [56-77] yrs), more likely to be admitted from home (87.8% vs 81.9%) and via the emergency department (73.0% vs 50.2%), but less likely to be for full resuscitation after (67.3% vs 76.5%) the MET. The three most common pre-MET breaches were low SpO2 (48.0%), high pulse rate (39.8%), and low systolic blood pressure (29.0%) which were present for a median (IQR) of 15.4 (7.5-20.8), 13.2 (4.3-21.0), and 12.6 (3.5-20.1) hrs before the MET call, respectively. Patients with pre-MET breaches were more likely to need intensive care admission within 24 h (15.6 vs 11.9%), have repeat MET calls (33.3 vs 24.7%), and die in hospital (15.8 vs 9.9%). CONCLUSIONS: Four-fifths of MET calls were preceded by pre-MET criteria breaches, which were present for many hours. Such patients were older, had more limits of treatment, and experienced worse outcomes. There is a need to improve goals of care documentation and pre-MET management of clinical deterioration.
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ItemNo Preview AvailableDevelopment of virus-like particles with inbuilt immunostimulatory properties as vaccine candidates(FRONTIERS MEDIA SA, 2023-06-07)The development of virus-like particle (VLP) based vaccines for human papillomavirus, hepatitis B and hepatitis E viruses represented a breakthrough in vaccine development. However, for dengue and COVID-19, technical complications, such as an incomplete understanding of the requirements for protective immunity, but also limitations in processes to manufacture VLP vaccines for enveloped viruses to large scale, have hampered VLP vaccine development. Selecting the right adjuvant is also an important consideration to ensure that a VLP vaccine induces protective antibody and T cell responses. For diseases like COVID-19 and dengue fever caused by RNA viruses that exist as families of viral variants with the potential to escape vaccine-induced immunity, the development of more efficacious vaccines is also necessary. Here, we describe the development and characterisation of novel VLP vaccine candidates using SARS-CoV-2 and dengue virus (DENV), containing the major viral structural proteins, as protypes for a novel approach to produce VLP vaccines. The VLPs were characterised by Western immunoblot, enzyme immunoassay, electron and atomic force microscopy, and in vitro and in vivo immunogenicity studies. Microscopy techniques showed proteins self-assemble to form VLPs authentic to native viruses. The inclusion of the glycolipid adjuvant, α-galactosylceramide (α-GalCer) in the vaccine formulation led to high levels of natural killer T (NKT) cell stimulation in vitro, and strong antibody and memory CD8+ T cell responses in vivo, demonstrated with SARS-CoV-2, hepatitis C virus (HCV) and DEN VLPs. This study shows our unique vaccine formulation presents a promising, and much needed, new vaccine platform in the fight against infections caused by enveloped RNA viruses.
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ItemNo Preview AvailablePoint-of-care detection of fibrosis in liver transplant surgery using near-infrared spectroscopy and machine learning(WILEY, 2023-11)INTRODUCTION: Visual assessment and imaging of the donor liver are inaccurate in predicting fibrosis and remain surrogates for histopathology. We demonstrate that 3-s scans using a handheld near-infrared-spectroscopy (NIRS) instrument can identify and quantify fibrosis in fresh human liver samples. METHODS: We undertook NIRS scans on 107 samples from 27 patients, 88 from 23 patients with liver disease, and 19 from four organ donors. RESULTS: Liver disease patients had a median immature fibrosis of 40% (interquartile range [IQR] 20-60) and mature fibrosis of 30% (10%-50%) on histopathology. The organ donor livers had a median fibrosis (both mature and immature) of 10% (IQR 5%-15%). Using machine learning, this study detected presence of cirrhosis and METAVIR grade of fibrosis with a classification accuracy of 96.3% and 97.2%, precision of 96.3% and 97.0%, recall of 96.3% and 97.2%, specificity of 95.4% and 98.0% and area under receiver operator curve of 0.977 and 0.999, respectively. Using partial-least square regression machine learning, this study predicted the percentage of both immature (R 2 = 0.842) and mature (R 2 = 0.837) with a low margin of error (root mean square of error of 9.76% and 7.96%, respectively). CONCLUSION: This study demonstrates that a point-of-care NIRS instrument can accurately detect, quantify and classify liver fibrosis using machine learning.
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ItemNo Preview AvailableDetermination of "borderline resectable" pancreatic cancer - A global assessment of 30 shades of grey.(Elsevier BV, 2023-11)BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with a poor prognosis. Accurate preoperative assessment using computed tomography (CT) to determine resectability is crucial in ensuring patients are offered the most appropriate therapeutic strategy. Despite the use of classification guidelines, any interobserver variability between reviewing surgeons and radiologists may confound decisions influencing patient treatment pathways. METHODS: In this multicentre observational study, an international group of 96 clinicians (42 hepatopancreatobiliary surgeons and 54 radiologists) were surveyed and asked to report 30 pancreatic CT scans of pancreatic cancer deemed borderline at respective multidisciplinary meetings (MDM). The degree of interobserver agreement in resectability among radiologists and surgeons was assessed and subgroup regression analysis was performed. RESULTS: Interobserver variability between reviewers was high with no unanimous agreement. Overall interobserver agreement was fair with a kappa value of 0.32 with a higher rate of agreement among radiologists over surgeons. CONCLUSION: Interobserver variability among radiologists and surgeons globally is high, calling into question the consistency of clinical decision making for patients with PDAC and suggesting that central review may be required for studies of neoadjuvant or adjuvant approaches in future as well as ongoing quality control initiatives, even amongst experts in the field.
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ItemNo Preview AvailableThe Dedicated Imaging Post-Prostatectomy for Enhanced Radiotherapy outcomes (DIPPER) trial protocol: a multicentre, randomised trial of salvage radiotherapy versus surveillance for low-risk biochemical recurrence after radical prostatectomy(WILEY, 2024-02)BACKGROUND: Salvage radiation therapy (SRT) and surveillance for low-risk prostate-specific antigen (PSA) recurrence have competing risks and benefits. The efficacy of early SRT to the prostate bed with or without pelvic lymph nodes compared to surveillance in patients with PSA recurrence after radical prostatectomy and no identifiable recurrent disease evident on prostate specific membrane antigen-positron emission tomography/computer tomography (PSMA-PET/CT) is unknown. STUDY DESIGN: The Dedicated Imaging Post-Prostatectomy for Enhanced Radiotherapy outcomes (DIPPER) is an open-label, multicentre, randomised Phase II trial. ENDPOINTS: The primary endpoint is 3-year event-free survival, with events comprising one of PSA recurrence (PSA ≥0.2 ng/mL higher than baseline), radiological evidence of metastatic disease, or initiation of systemic or other salvage treatments. Secondary endpoints include patient-reported outcomes, treatment patterns, participant perceptions, and cost-effectiveness. ELIGIBILITY CRITERIA: Eligible participants have PSA recurrence of prostate cancer after radical prostatectomy, defined by serum PSA level of 0.2-0.5 ng/mL, deemed low risk according to modified European Association of Urology biochemical recurrence risk criteria (International Society for Urological Pathology Grade Group ≤2, PSA doubling time >12 months), with no definite/probable recurrent prostate cancer on PSMA-PET/CT. PATIENTS AND METHODS: A total of 100 participants will be recruited from five Australian centres and randomised 1:1 to SRT or surveillance. Participants will undergo 6-monthly clinical evaluation for up to 36 months. Androgen-deprivation therapy is not permissible. Enrolment commenced May 2023. TRIAL REGISTRATION: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622001478707).