SCANPatient: study protocol for a multi-centre, batched, stepped wedge, comparative effectiveness, randomised clinical trial of synoptic reporting of computerised tomography (CT) scans assessing cancers of the pancreas.

BACKGROUND: Complete surgical removal of pancreatic ductal adenocarcinoma (PDAC) is central to all curative treatment approaches for this aggressive disease, yet this is only possible in patients technically amenable to resection. Hence, an accurate assessment of whether patients are suitable for surgery is of paramount importance. The SCANPatient trial aims to test whether implementing a structured synoptic radiological report results in increased institutional accuracy in defining surgical resectability of non-metastatic PDAC. METHODS: SCANPatient is a batched, stepped wedge, comparative effectiveness, cluster randomised clinical trial. The trial will be conducted at 33 Australian hospitals all of which hold regular multi-disciplinary team meetings (MDMs) to discuss newly diagnosed patients with PDAC. Each site is required to manage a minimum of 20 patients per year (across all stages). Hospitals will be randomised to begin synoptic reporting within a batched, stepped wedge design. Initially all hospitals will continue to use their current reporting method; within each batch, after each 6-month period, a randomly selected group of hospitals will commence using the synoptic reports, until all hospitals are using synoptic reporting. Each hospital will provide data from patients who (i) are aged 18 or older; (ii) have suspected PDAC and have an abdominal CT scan, and (iii) are presented at a participating MDM. Non-metastatic patients will be documented as one of the following categories: (1) locally advanced and surgically unresectable; (2) borderline resectable; or (3) anatomically clearly resectable (Note: Metastatic disease is treated as a separate category). Data collection will last for 36 months in each batch, and a total of 2400 patients will be included. DISCUSSION: Better classifying patients with non-metastatic PDAC as having tumours that are either clearly resectable, borderline or locally advanced and unresectable may improve patient outcomes by optimising care and treatment planning. The borderline resectable group are a small but important cohort in whom surgery with curative intent may be considered; however, inconsistencies with definitions and an understanding of resectability status means these patients are often incorrectly classified and hence overlooked for curative options. TRIAL REGISTRATION: The SCANPatient trial was registered on 17th May 2023 in the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12623000508673).

The Unmet Needs of Pancreatic Cancer Carers Are Associated with Anxiety and Depression in Patients and Carers.

Pancreatic cancer has one of the lowest survival rates, and patients experience debilitating symptoms. Family carers provide essential daily care. This study determined the prevalence of and risk factors for unmet supportive care needs among carers for pancreatic cancer patients and examined which carer needs were associated with anxiety and depression in carers and patients. Eighty-four pancreatic cancer patients and their carers were recruited. The carers completed a needs survey (SCNS-P&C). Both carers and patients completed the Hospital Anxiety and Depression Scale. Log binomial regression was used to identify associations between carer needs and anxiety and depression among carers and patients. The top 10 moderate-to-high unmet needs reported by ≥28% of carers were related to healthcare (e.g., discussing concerns with doctors) and information need domains (e.g., information about a patient's physical needs), plus one other item related to hospital parking. Being male or caring for a patient within 4 months of their diagnosis were associated with greater unmet needs. Some unmet needs, including 'accessing information about treatments' and 'being involved in patient care', were associated with both carers and patients having anxiety and depression. Carers should be involved in health care consultations and provided with information and opportunities to discuss concerns.

Laparoscopic fundoplication performed in community hospital settings: A protocol for systematic review.

BACKGROUND: Laparoscopic fundoplication (LF) is well-established as the surgical intervention of choice for management of refactory gastro-esophageal reflux disease. Much of its success lies in the reported benefits in symptom control outlined by the postoperative patient. It is unclear whether patient-reported outcomes differ according to the institution type providing care. This review aimed to address this knowledge gap by reviewing the available evidence examining patient-reported outcomes of LF in non-metropolitan centers. OBJECTIVES: To investigate patient-reported outcomes of LF performed in regional or community-based hospitals. DATA SOURCES: Four electronic databases, and citations of relevant articles. STUDY ELIGIBILITY CRITERIA: Only studies that separately reported patient-reported outcomes of LF performed in regional or community hospitals were included; papers deemed to be unclear about the type of facility in which LF surgeries were performed, or in which data from LF surgeries performed in regional/community hospitals was combined with data from major metropolitan hospitals, were excluded. STUDY APPRAISAL: Only studies that were graded as fair or good using Quality Assessment Tool for Observational Cohort and Cross-sectional studies were eligible for inclusion in this review. Seven studies were then eligible for inclusion, all of which were observational cohort studies with 6 of the studies reporting on a single intervention arm. RESULTS: Seven observational cohort studies were included in the review, with a combined total of 1071 patients who underwent LF at non-metropolitan centers. Of these, data was collected for 742 patients, yielding an overall response rate of 69.3%. All 7 studies assessed patients' post-operative outcomes through questionnaires that were based on a modified Likert scale or a similar tool. Overall patient satisfaction was high (86%) and a significant majority of patients stated they would recommend the procedure to others (93.3%). Post-operative prevalence of reflux and dysphagia compared favorably to rates generally reported in the literature (11.9% and 17.6% respectively). Further research is required to ascertain the safety of performing these procedures in non-metropolitan hospitals. CONCLUSION: Current evidence suggests that patient-reported outcomes are favorable for patients undergoing LF in community settings, and are broadly comparable to those undergoing LF in tertiary-level centers.

Loop and drain technique for prevention of surgical site infection in upper gastrointestinal surgery.

INTRODUCTION: Hepatobiliary and pancreatic surgery is frequently complicated by surgical site infections (SSI) with significant postoperative morbidity and mortality rates contributing to the economic burden on healthcare. Advancements in operative techniques to prevent SSI are gaining traction in clinical practice. This study compares the effectiveness of the 'loop and drain technique (LDT)', a combination method utilizing a continuous subcutaneous vessel loop and subcuticular suture for surgical wound closure in patients undergoing upper gastrointestinal surgery at a Metropolitan Hospital in Sydney. METHODS: A retrospective review of patients who underwent an upper gastrointestinal procedure was conducted at Bankstown-Lidcombe hospital between 2017 and 2019. There were 77 patients in the LDT group and 123 patients included in the control group. The primary outcome assessed was the rate of SSI. Secondary outcomes included length of stay (LOS) and drainage of surgical site infections. RESULT: Two hundred adult patients were treated for an upper gastrointestinal procedure. The most common operation was a Whipple procedure (35.0%). The rate of SSI was 12.5% with all these patients receiving intravenous antibiotics. The LDT cohort had a significantly lower rate of SSI compared to their counterparts (3.9% vs. 17.9%, P = 0.004). CONCLUSION: The LDT method is associated with a decreased incidence of SSI and should be considered as a cost-effective operative technique to improve patient outcomes after upper gastrointestinal surgery.

Association between neutrophil-lymphocyte ratio and lymph node metastasis in gastric cancer: A meta-analysis.

INTRODUCTION AND AIM: The prognostic role of neutrophil to lymphocyte ratio (NLR) has been explored extensively in the literature. The aim of this meta-analysis was to evaluate the link between NLR and lymph node metastasis in gastric cancer. A method for increasing specificity and sensitivity of pre-treatment staging has implications on treatment algorithms and survival. SEARCH STRATEGY: The relevant databases were searched as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flowchart. After selection, 12 full text articles that met the inclusion criteria were included for quantitative analysis. 2 × 2 squares were generated using lymph node positive/negative, and NLR high/low data. The effect size for each study was calculated using the DerSimonian-Laird random effects model. P values were calculated using the chi-square method. Finally publication bias was evaluated. All statistics were calculated using R Studio. RESULTS: Meta-analysis showed a 1.90 times (odds ratio, with 95% CI 1.52-2.38) increase in risk of positive lymph node status with high neutrophil to lymphocyte ratio. This has significant implications for cancer screening and staging, as NLR is a highly reproducible, cost-effective, and widely available prognostic factor for gastric cancer patients. Additionally, high or low NLR values may have implications for management pathways. Patients with lymph node metastasis can be offered neoadjuvant chemotherapy, avoiding salvage therapy in the form of adjuvant chemoradiotherapy, which is poorly tolerated. CONCLUSION: This meta-analysis shows an association between NLR and positive lymph node status in gastric cancer patients with implications for staging, as well as preoperative personalisation of therapy.

Pancreatic cancer survival by stage and age in seven high-income countries (ICBP SURVMARK-2): a population-based study.

BACKGROUND: The global burden of pancreatic cancer has steadily increased, while the prognosis after pancreatic cancer diagnosis remains poor. This study aims to compare the stage- and age-specific pancreatic cancer net survival (NS) for seven high-income countries: Australia, Canada, Denmark, Ireland, New Zealand, Norway, and United Kingdom. METHODS: The study included over 35,000 pancreatic cancer cases diagnosed during 2012-2014, followed through 31 December 2015. The stage- and age-specific NS were calculated using the Pohar-Perme estimator. RESULTS: Pancreatic cancer survival estimates were low across all 7 countries, with 1-year NS ranging from 21.1% in New Zealand to 30.9% in Australia, and 3-year NS from 6.6% in the UK to 10.9% in Australia. Most pancreatic cancers were diagnosed with distant stage, ranging from 53.9% in Ireland to 83.3% in New Zealand. While survival differences were evident between countries across all stage categories at one year after diagnosis, this survival advantage diminished, particularly in cases with distant stage. CONCLUSION: This study demonstrated the importance of stage and age at diagnosis in pancreatic cancer survival. Although progress has been made in improving pancreatic cancer prognosis, the disease is highly fatal and will remain so without major breakthroughs in the early diagnosis and management.

Prognostic models to predict survival in patients with pancreatic cancer: a systematic review.

BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) has poor survival. Current treatments offer little likelihood of cure or long-term survival. This systematic review evaluates prognostic models predicting overall survival in patients diagnosed with PDAC. METHODS: We conducted a comprehensive search of eight electronic databases from their date of inception through to December 2019. Studies that published models predicting survival in patients with PDAC were identified. RESULTS: 3297 studies were identified; 187 full-text articles were retrieved and 54 studies of 49 unique prognostic models were included. Of these, 28 (57.1%) were conducted in patients with advanced disease, 17 (34.7%) with resectable disease, and four (8.2%) in all patients. 34 (69.4%) models were validated, and 35 (71.4%) reported model discrimination, with only five models reporting values >0.70 in both derivation and validation cohorts. Many (n = 27) had a moderate to high risk of bias and most (n = 33) were developed using retrospective data. No variables were unanimously found to be predictive of survival when included in more than one study. CONCLUSION: Most prognostic models were developed using retrospective data and performed poorly. Future research should validate instruments performing well locally in international cohorts and investigate other potential predictors of survival.

Diabetes Adversely Influences Postoperative Outcomes After Oesophagectomy: An Analysis of the National Surgical Quality Improvement Program Database.

INTRODUCTION: Diabetes is a recognised risk for several chronic and acute illnesses, including increased complications in surgery for oesophageal cancer. Our primary aim is to determine the impact of diabetes on postoperative surgical and medical complications after oesophagectomy. METHODS: All oesophagectomies for malignancy as reflected in the 2016-2018 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) datasets were extracted and analysed. Current Procedural Terminology (CPT) codes used were 1) open procedures (43107, 43108, 43112, 43113, 43116, 43117, 43118, 43121, 43122, and 43123) and 2) hybrid procedures (43186, 43287, and 43288). Logistic regression models examined associations between diabetic status and adverse outcomes. The associations were adjusted for sex, race, age group, operation year, CPT code, body mass index (BMI), smoking, congestive heart failure, antihypertensives, renal failure, and dyspnoea. RESULTS: Two thousand five hundred and thirty-eight oesophagectomies were identified. 86.45% (n=2,194) underwent open procedures and 13.55% (n=344) had hybrid procedures. There were 177 insulin-dependent diabetics (IDDM) and 320 (12.61%) non-insulin-dependent diabetics (NIDDM). 84.14% were male and 77.74% were Caucasian. 89.48% of the patients were between 50 and 79 years of age. 40.27% experienced postoperative complications. Medical complications (odds ratio [OR]: 1.7, p-value: 0.002), surgical complications (OR: 1.9, p-value: <0.001), wound complications (OR: 2.9, p-value: <0.001), and anastomotic leaks (OR: 2.4, p-value: <0.001) were more common in diabetic patients. Subgroup analysis showed that in hybrid procedures, there is a statistically significant increase in the OR of surgical complications (OR: 3.61, p-value: 0.05), medical complications (OR: 3.76, p-value: 0.04), and anastomotic leak (OR: 3.49, p-value: 0.27) in IDDM as compared to NIDDM. CONCLUSION: Insulin-dependent diabetes doubles the risk of all major complications compared to nondiabetics. When considering surgical approach and diabetic status (IDDM vs nondiabetics, NIDDM vs nondiabetics), the risk of complications further doubles for hybrid oesophagectomies compared to open procedures.

The association between quality care and outcomes for a real-world population of Australian patients diagnosed with pancreatic cancer.

BACKGROUND: This study: (i) assessed compliance with a consensus set of quality indicators (QIs) in pancreatic cancer (PC); and (ii) evaluated the association between compliance with these QIs and survival. METHODS: Four years of data were collected for patients diagnosed with PC. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). A multivariable analysis tested the relationship between significant patient and hospital characteristics, patient cluster effects within hospitals and survival. RESULTS: 1061 patients were eligible for this study. Significant association with improved survival were: (i) in the potentially resectable group having adjuvant chemotherapy administered following surgery or a reason documented (HR, 0.29; 95 CI, 0.19-0.46); (ii) in the locally advanced group included having chemotherapy ± chemoradiation, or a reason documented for not undergoing treatment (HR, 0.38; 95 CI, 0.25-0.58); and (iii) in the metastatic disease group included having documented performance status at presentation (HR, 0.65; 95 CI, 0.47-0.89), being seen by an oncologist in the absence of treatment (HR, 0.48; 95 CI, 0.31-0.77), and disease management discussed at a multidisciplinary team meeting (HR, 0.79; 95 CI, 0.64-0.96). CONCLUSION: Capture of a concise data set has enabled quality of care to be assessed.

International variation in oesophageal and gastric cancer survival 2012-2014: differences by histological subtype and stage at diagnosis (an ICBP SURVMARK-2 population-based study).

OBJECTIVE: To provide the first international comparison of oesophageal and gastric cancer survival by stage at diagnosis and histological subtype across high-income countries with similar access to healthcare. METHODS: As part of the ICBP SURVMARK-2 project, data from 28 923 patients with oesophageal cancer and 25 946 patients with gastric cancer diagnosed during 2012-2014 from 14 cancer registries in seven countries (Australia, Canada, Denmark, Ireland, New Zealand, Norway and the UK) were included. 1-year and 3-year age-standardised net survival were estimated by stage at diagnosis, histological subtype (oesophageal adenocarcinoma (OAC) and oesophageal squamous cell carcinoma (OSCC)) and country. RESULTS: Oesophageal cancer survival was highest in Ireland and lowest in Canada at 1 (50.3% vs 41.3%, respectively) and 3 years (27.0% vs 19.2%) postdiagnosis. Survival from gastric cancer was highest in Australia and lowest in the UK, for both 1-year (55.2% vs 44.8%, respectively) and 3-year survival (33.7% vs 22.3%). Most patients with oesophageal and gastric cancer had regional or distant disease, with proportions ranging between 56% and 90% across countries. Stage-specific analyses showed that variation between countries was greatest for localised disease, where survival ranged between 66.6% in Australia and 83.2% in the UK for oesophageal cancer and between 75.5% in Australia and 94.3% in New Zealand for gastric cancer at 1-year postdiagnosis. While survival for OAC was generally higher than that for OSCC, disparities across countries were similar for both histological subtypes. CONCLUSION: Survival from oesophageal and gastric cancer varies across high-income countries including within stage groups, particularly for localised disease. Disparities can partly be explained by earlier diagnosis resulting in more favourable stage distributions, and distributions of histological subtypes of oesophageal cancer across countries. Yet, differences in treatment, and also in cancer registration practice and the use of different staging methods and systems, across countries may have impacted the comparisons. While primary prevention remains key, advancements in early detection research are promising and will likely allow for additional risk stratification and survival improvements in the future.

Comparison of liver cancer incidence and survival by subtypes across seven high-income countries.

International comparison of liver cancer survival has been hampered due to varying standards and degrees for morphological verification and differences in coding practices. This article aims to compare liver cancer survival across the International Cancer Benchmarking Partnership's (ICBP) jurisdictions whilst trying to ensure that the estimates are comparable through a range of sensitivity analyses. Liver cancer incidence data from 21 jurisdictions in 7 countries (Australia, Canada, Denmark, Ireland, New Zealand, Norway and the United Kingdom) were obtained from population-based registries for 1995-2014. Cases were categorised based on histological classification, age-groups, basis of diagnosis and calendar period. Age-standardised incidence rate (ASR) per 100 000 and net survival at 1 and 3 years after diagnosis were estimated. Liver cancer incidence rates increased over time across all ICBP jurisdictions, particularly for hepatocellular carcinoma (HCC) with the largest relative increase in the United Kingdom, increasing from 1.3 to 4.4 per 100 000 person-years between 1995 and 2014. Australia had the highest age-standardised 1-year and 3-year net survival for all liver cancers combined (48.7% and 28.1%, respectively) in the most recent calendar period, which was still true for morphologically verified tumours when making restrictions to ensure consistent coding and classification. Survival from liver cancers is poor in all countries. The incidence of HCC is increasing alongside the proportion of nonmicroscopically verified cases over time. Survival estimates for all liver tumours combined should be interpreted in this context. Care is needed to ensure that international comparisons are performed on appropriately comparable patients, with careful consideration of coding practice variations.

Real world outcomes of neoadjuvant chemotherapy and radiotherapy for borderline resectable pancreatic cancer: a multicentre observational study.

BACKGROUND: Neoadjuvant therapy may increase the likelihood of complete (R0) resection for borderline resectable pancreatic cancer. The optimal approach is unknown and differs amongst treatment centres. METHODS: We identified patients with biopsy-proven borderline resectable pancreatic adenocarcinoma who commenced neoadjuvant therapy between January 2012 and June 2019 at three centres in Sydney, Australia. Patterns of care and outcomes of varying approaches were examined. RESULTS: Forty-eight patients were identified. Median age was 66 years (range: 41-84). Staging included endoscopic ultrasound in 98%, PET-CT scan in 77%, laparoscopy in 46%. Neoadjuvant regimens used were a combination of chemotherapy and chemo-radiation (58%), chemotherapy alone (13%) and chemoradiation alone (29%). Radiologic complete or partial response occurred in 33% and progression in 25%. Complete macroscopic surgical resection was achieved in 50%, and R0 resection in 38%. At median follow-up of 15 months, the 1-year and 2-year overall survival was 75% and 63% respectively, and the 1-year and 2-year progression-free survival was 50% and 29% respectively. Significant predictors of macroscopic resectability were radiologic response (p = 0.005) but not addition of radiotherapy to chemotherapy (OR 0.87, p = 0.81). Predictors of overall survival included baseline Ca19.9 level (p = 0.04) and a trend to the use of systemic chemotherapy (HR 0.51, p = 0.07), but not use of radiotherapy (HR 0.70, p = 0.47). CONCLUSION: There is high variability in staging and neoadjuvant approaches for borderline resectable pancreas cancer. Despite aggressive neoadjuvant therapies, R0 resection and prolonged survival are uncommon. The incremental benefit of neoadjuvant radiotherapy after neoadjuvant chemotherapy was not demonstrated in this observational study.

How to perform transcystic stenting in the COVID-19 pandemic: an approach to biliary stenting without specialized endobiliary stenting equipment.

Management options for common bile duct stones found at laparoscopic cholecystectomy (LC) includes concurrent transcystic biliary stenting, effectively providing a conduit for common bile duct drainage and improving the success of subsequent endoscopic retrograde cholangiopancreatography. In the unprecedented COVID-19 pandemic however, potential disruptions to the medical supply chain have been far reaching, including the distribution of specialised biliary stent sets. To overcome this, we devised an innovative method at our centre to substitute traditional procedural stent sets by employing standard, universally accessible open-ended ureteral catheters, jagwires and pancreatic or biliary stents with similar procedural success.

International trends in oesophageal cancer survival by histological subtype between 1995 and 2014.

INTRODUCTION: Survival from oesophageal cancer remains poor, even across high-income countries. Ongoing changes in the epidemiology of the disease highlight the need for survival assessments by its two main histological subtypes, adenocarcinoma (AC) and squamous cell carcinoma (SCC). METHODS: The ICBP SURVMARK-2 project, a platform for international comparisons of cancer survival, collected cases of oesophageal cancer diagnosed 1995 to 2014, followed until 31st December 2015, from cancer registries covering seven participating countries with similar access to healthcare (Australia, Canada, Denmark, Ireland, New Zealand, Norway and the UK). 1-year and 3-year age-standardised net survival alongside incidence rates were calculated by country, subtype, sex, age group and period of diagnosis. RESULTS: 111 894 cases of AC and 73 408 cases of SCC were included in the analysis. Marked improvements in survival were observed over the 20-year period in each country, particularly for AC, younger age groups and 1 year after diagnosis. Survival was consistently higher for both subtypes in Australia and Ireland followed by Norway, Denmark, New Zealand, the UK and Canada. During 2010 to 2014, survival was higher for AC compared with SCC, with 1-year survival ranging from 46.9% (Canada) to 54.4% (Ireland) for AC and 39.6% (Denmark) to 53.1% (Australia) for SCC. CONCLUSION: Marked improvements in both oesophageal AC and SCC survival suggest advances in treatment. Less marked improvements 3 years after diagnosis, among older age groups and patients with SCC, highlight the need for further advances in early detection and treatment of oesophageal cancer alongside primary prevention to reduce the overall burden from the disease.