Abstract Introduction The combination of 5-flurouracil, oxaliplatin, leucovorin and docetaxel (FLOT) is an effective chemotherapy regime in locally advanced, resectable gastro-oesophageal adenocarcinoma. Since the FLOT4-AIO randomised controlled trial demonstrated superiority over ECF/ECX it has been standard of care at many centres and European Society of Medical Oncology’s recommended perioperative regimen. After over five years of offering this treatment to patients we assessed how this evidence had translated into practice; identifying factors that predict dose reduction or incomplete therapy and overall survival. Method Patients who had the combination of neoadjuvant FLOT chemotherapy and oesophagectomy for adenocarcinoma of the oesophagus or gastro-oesophageal junction between February 2018 and September 2023 were identified from a prospectively collected database. Data on completion of chemotherapy, perioperative outcomes and long-term survival were collected. Pathological regression was assessed using Mandard tumour regression grade (TRG). The peri-operative, pathological, and long-term outcomes of patients who completed four cycles of neoadjuvant FLOT was compared with those who had reduced dose or early cessation. Statistical analysis used IBM SPSS, with Mann-Whitney U and Chi squared for variable analysis and univariate cox regression for survival. Results Eighty patients were included with a median age of 66 (47-79), 84% were male. Full dose completion was achieved by 57 (71%) patients, 20 (25%) had dose reduction and 7(8%) did not complete four cycles. Age, anaerobic threshold and VO2 max were not significantly different between those completing or not completing neoadjuvant chemotherapy (p=0.460, p=0.624, p=0.104 respectively); or requiring dose reductions (p=0.317, p=0.587, p=0.82). Median TRG across all three groups was 3. Median follow up was 55.4 months and mean overall survival was 53.4 months. No difference in survival was observed between those who completed or did not complete neoadjuvant FLOT (p=0.45). Conclusion Completion of neoadjuvant chemotherapy was lower in this cohort of patients than FLOT4-AIO. Rates of pathological complete response were similar. This translated into similar mean overall survival. Median survival was unable to be calculated as survival exceeds 50% at the time of our study. The use of FLOT has translated well into the routine neoadjuvant clinical setting with acceptable short- and long-term outcomes.
Abstract Background There’s a growing interest towards the prognostic value of circumferential resection margin (CRM) involvement in oesophageal cancers. However, there is no sufficient data about the association of the site-specific CRM and survival. In this study, we analysed the influence of different involved CRM sites on survival. Methods This study included patients who had curative oesophagectomy for oesophageal cancer between 2010 till June 2021. Follow up till April 2022 was achieved. Patients with involved proximal or distal margins were excluded. The sites of CRM were defined anatomically to anterior (pericardial), posterior (aorta), lateral (pleurae). The outcomes between different CRM margins were retrospectively analysed. The long-term follow up data was obtained via direct contact with the patients during our oncological clinics, cross-checked with our hospital/national patients’ electronic databases. Results 117 patients had CRM-positive after curative oesophagectomy during the study period. 33 cases had multi-involved CRM sites, while 84 patients had single involved CRM site. Posterior margins were the most common involved site 37/117 (31.6%). No differences in baseline pathological criteria (pT, pN stages and type of cancer) and neoadjuvant therapy. Positive anterior margins carried the worst overall (OS) and disease-free (DFS) survival compared to lateral and posterior margins (OS: 29 vs 41 vs 32 months respectively, p-value 0.37, DFS: 19.2 vs 32.1 vs 28.7 months respectively, p-value 0.39). Multi-involved CRM sites led to worse OS and DFS in comparison with single involved CRM site (OS: 19 vs 32 months respectively, p-value 0.008, DFS: 12.1 months vs 27.6 months respectively, p-value 0.05). Conclusion The site of involved CRM should be rigorously assessed in oesophagectomy specimens. The involved margin sites within CRM had different survival rates, with inferiority towards anterior resection margins. Larger studies are required to better evaluate the prognostic significance of various CRM sites.
Objective: This study aimed to compare the postoperative and pathological outcomes between carboplatin, paclitaxel, radiotherapy (CROSS) and 5-FU, leucovorine, oxaliplatin and docetaxel (FLOT) in esophageal adenocarcinoma (EAC) patients from an international, multicenter cohort. Summary of Background Data: Ongoing debate exists around optimum approach to locally advanced EAC, with proponents for perioperative chemotherapy, such as FLOT, or multimodal therapy, in particular the CROSS regimen. Methods: Patients undergoing CROSS (n = 350) and FLOT (n = 368), followed by curative esophagectomy for EAC were identified from the Oesophagogastric Anastomosis Audit. Results: The 90-day mortality was higher after CROSS than FLOT (5% vs 1%, P = 0.005), even on adjusted analyses [odds ratio (OR): 3.97, confidence interval (CI)(95%): 1.34-13.67]. Postoperative mortality in CROSS were related to higher pulmonary (74% vs 60%) and cardiac complications (42% vs 20%) compared to FLOT. CROSS was associated with higher pathologic complete response (pCR) rates (18% vs 10%, P = 0.004) and margin-negative resections (93% vs 76%, P < 0.001) compared with FLOT. On adjusted analyses, CROSS was associated with higher pCR rates (OR: 2.05, CI95%: 1.26-3.34) and margin-negative resections (OR: 4.55, CI95%: 2.70-7.69) compared to FLOT. Conclusions: This study provides real-world data CROSS was associated with higher 90-day mortality than FLOT, related to cardio-pulmonary complications with CROSS. These warrant a further review into causes and mechanisms in selected patients, and at minimum suggest the need for strict radiation therapy quality assurance. Research into impact of higher pCR rates and R0 resections with CROSS compared to FLOT on long-term survival is needed.
Abstract Background The definition of CRM (circumferential resection margins) for oesophageal cancers varies among the international pathological bodies with an ongoing controversy about the optimal definition. There is also no enough data about the prognostic relevance of different sites in CRM. In this study, we examined the prognostic impacts of different CRM distances and sites. Methods This study included patients who had curative oesophagectomy for oesophageal cancer between 2010 till June 2021. Follow up till April 2022 was achieved. CRM status was carefully examined for the distance and site of involved tumour cells. Patients with involved proximal or distal margins were excluded. The outcomes between different CRM margins were retrospectively analysed. The long-term follow up data was obtained via direct contact with the patients during our oncological clinics, cross-checked with our hospital/national patients’ electronic databases. Results 456 patients were included in this study. Involved tumour cells within 1mm of CRM was observed in 192 patients (42.1%). CRM+ (<1mm) was associated with worse overall (OS) and disease-free survival (DFS) (22.8 and 16.3 months respectively) compared to CRM-negative (47.7 and 45.1 months respectively), (p-value <0.001 for both). CRM+ (0mm) had worse OS and DFS (20.5 and 12 months respectively) compared to CRM+(0.1–1mm) (26.4 and 20 months respectively), (p-values 0.028 and 0.006 respectively). CRM-positive posterior margin was the most common involved site (32%), but was associated with better OS and DFS compared to anterior and lateral sites, (p-values 0.1 and 0.08 respectively). Conclusions The site and distance of tumour cells within CRM should be rigorously assessed in oesophagectomy specimens. The presence of tumour cells within 1mm of CRM was an independent factor for OS and DFS. The CRM+(0 mm) had significant lower survival rates compared to other CRM+ distances (0.1–1 mm). The involved margin sites within CRM had different survival rates, with superiority towards posterior resection margins.
INTRODUCTION:Laparoscopic surgery is technically challenging and assessment of competency is necessary to ensure patient safety and guide training. We report on the development of LapPass®, an accessible objective simulation assessment tool with credentialing potential. We provide a preliminary evaluation of its usability and aspects of validity.METHODS:The domains of LapPass® were defined through a consensus process by the executive council of the Association of Laparoscopic Surgeons of Great Britain and Ireland (ALSGBI). A survey of both assessors and trainees was used to test for usability, face and content validity of LapPass®. Internal consistency was tested with Cronbach's alpha, and a composite marker of validity and usability was obtained.RESULTS:LapPass® was developed to consist of four tasks: (1) grasping and manipulation, (2) simulated appendicectomy, (3) cutting a disk and (4) intracorporeal suturing. A total of 76 participants contributed to the evaluation of LapPass®: 13 assessors and 63 trainees. For assessors, Cronbach's alpha for usability of tasks 1-4 was 0.84, 0.84, 0.76 and 0.86, whereas validity was 0.80, 0.85, 0.88, 0.95, respectively. For trainees, Cronbach's alpha was 0.75, 0.77, 0.80 and 0.85 for usability, and 0.79, 093, 0.87 and 0.91 for validity. Consensus was that each task was usable and had face and content validity, with median scores of 4.0 or higher (interquartile range 0.0-1.0).CONCLUSION:LapPass® has potential for the objective assessment of basic laparoscopic skills but further research is required to explore its predictive capabilities in a clinical setting.
Background: No evidence currently exists characterising global outcomes following major cancer surgery, including esophageal cancer. Therefore, this study aimed to characterise impact of high income countries (HIC) versus low and middle income countries (LMIC) on the outcomes following esophagectomy for esophageal cancer. Method: This international multi-center prospective study across 137 hospitals in 41 countries included patients who underwent an esophagectomy for esophageal cancer, with 90-day follow-up. The main explanatory variable was country income, defined according to the World Bank Data classification. The primary outcome was 90-day postoperative mortality, and secondary outcomes were composite leaks (anastomotic leak or conduit necrosis) and major complications (Clavien-Dindo Grade III-V). Multivariable generalized estimating equation models were used to produce adjusted odds ratios (ORs) and 95% confidence intervals (CI95%). Results: Between April 2018 to December 2018, 2247 patients were included. Patients from HIC were more significantly older, with higher ASA grade, and more advanced tumors. Patients from LMIC had almost three-fold increase in 90-day mortality, compared to HIC (9.4% vs 3.7%, p < 0.001). On adjusted analysis, LMIC were independently associated with higher 90-day mortality (OR: 2.31, CI95%: 1.17-4.55, p = 0.015). However, LMIC were not independently associated with higher rates of anastomotic leaks (OR: 1.06, CI95%: 0.57-1.99, p = 0.9) or major complications (OR: 0.85, CI95%: 0.54-1.32, p = 0.5), compared to HIC. Conclusion: Resections in LMIC were independently associated with higher 90-day postoperative mortality, likely reflecting a failure to rescue of these patients following esophagectomy, despite similar composite anastomotic leaks and major complication rates to HIC. These findings warrant further research, to identify potential issues and solutions to improve global outcomes following esophagectomy for cancer. (C) 2020 Elsevier Ltd, BASO similar to The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.
AbstractBackgroundThe complexity of oesophageal surgery and the significant risk of morbidity necessitates that oesophagectomy is predominantly performed by a consultant surgeon, or a senior trainee under their supervision. The aim of this study was to determine the impact of trainee involvement in oesophagectomy on postoperative outcomes in an international multicentre setting.MethodsData from the multicentre Oesophago-Gastric Anastomosis Study Group (OGAA) cohort study were analysed, which comprised prospectively collected data from patients undergoing oesophagectomy for oesophageal cancer between April 2018 and December 2018. Procedures were grouped by the level of trainee involvement, and univariable and multivariable analyses were performed to compare patient outcomes across groups.ResultsOf 2232 oesophagectomies from 137 centres in 41 countries, trainees were involved in 29.1 per cent of them (n = 650), performing only the abdominal phase in 230, only the chest and/or neck phases in 130, and all phases in 315 procedures. For procedures with a chest anastomosis, those with trainee involvement had similar 90-day mortality, complication and reoperation rates to consultant-performed oesophagectomies (P = 0.451, P = 0.318, and P = 0.382, respectively), while anastomotic leak rates were significantly lower in the trainee groups (P = 0.030). Procedures with a neck anastomosis had equivalent complication, anastomotic leak, and reoperation rates (P = 0.150, P = 0.430, and P = 0.632, respectively) in trainee-involved versus consultant-performed oesophagectomies, with significantly lower 90-day mortality in the trainee groups (P = 0.005).ConclusionTrainee involvement was not found to be associated with significantly inferior postoperative outcomes for selected patients undergoing oesophagectomy. The results support continued supervised trainee involvement in oesophageal cancer surgery.
Background: For patients in whom laparoscopic adjustable gastric band has failed, conversion to Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy are both options for further surgical treatment. There are limited data comparing these 2 procedures. The National Bariatric Surgery Registry is a comprehensive United Kingdom-wide database of bariatric procedures, in which preoperative demographic characteristics and clinical outcomes are prospectively recorded. Objectives: To compare perioperative complication rate and short-term outcomes of patients undergoing single-stage conversion of gastric band to Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy. Setting: United Kingdom national bariatric surgery database. Methods: From the National Bariatric Surgical Registry data set, we identified 141 patients undergoing single-stage conversion from gastric band to either gastric bypass (113) or sleeve gastrectomy (28) between 2009 and 2014, and analyzed their clinical outcomes. Results: With respect to perioperative outcomes gastric bypass was associated with a higher incidence of readmission or reintervention postoperatively (16 versus 0; P=.04). There was no difference in percentage excess weight loss between sleeve gastrectomy and gastric bypass at final follow-up at 1 year (52.1% versus 57.1% respectively; P=.4). Conclusions: Conversion from band to sleeve or bypass give comparable good early excess weight loss; however, conversion to sleeve is associated with a better perioperative safety profile. Crown Copyright (C) 2018 Published by Elsevier Inc. on behalf of American Society for Bariatric Surgery. All rights reserved.
Background The National Bariatric Surgery Registry (NBSR) is the largest bespoke database in the field in the United Kingdom. Objectives Our aim was to analyze the NBSR to determine whether the effects of obesity surgery on associated co-morbidities observed in small randomized controlled clinical trials could be replicated in a "real life" setting within U.K. healthcare. Setting United Kingdom. Methods All NBSR entries for operations between 2000 and 2015 with associated demographic and co-morbidity data were analyzed retrospectively. Results A total of 50,782 entries were analyzed. The patients were predominantly female (78%) and white European with a mean age of 45 ± 11 years and a mean body mass index of 48 ± 8 kg/m2. Over 5 years of follow-up, statistically significant reductions in the prevalence of type 2 diabetes, hypertension, dyslipidemia, sleep apnea, asthma, functional impairment, arthritis, and gastroesophageal reflux disease were observed. The "remission" of these co-morbidities was evident 1 year postoperatively and reached a plateau 2 to 5 years after surgery. Obesity surgery was particularly effective on functional impairment and diabetes, almost doubling the proportion of patients able to climb 3 flights of stairs and halving the proportion of patients with diabetes related hyperglycemia compared with preoperatively. Surgery was safe with a morbidity of 3.1% and in-hospital mortality of .07% and a reduced median inpatient stay of 2 days, despite an increasingly sick patient population. Conclusions Obesity surgery in the U.K. results not only in weight loss, but also in substantial improvements in obesity-related co-morbidities. Appropriate support and funding will help improve the quality of the NBSR data set even further, thus enabling its use to inform healthcare policy.
Background: Bowel length measurement is a vital component of bariatric bypass procedures as limb lengths have a profound effect on patient outcomes.In general surgery, measurement is important in situations such as small bowel resection.Techniques have been suggested to guide measurement and increase accuracy for example introducing a measuring tape into the abdomen, demonstrating instrument dimensions, or marking viscera.We undertook a study to assess the accuracy of estimated measurement, and investigate the impact of simple length guide on this estimation.Methods: 14 surgeons of varying seniority were asked to measure 150 cm of a cord in a laparoscopic surgery simulator.Accuracy and time to complete the measurement were recorded.Following the initial attempt, a laparoscopic grasper marked with a 10cm measurement was provided and the process repeated to assess for a change in accuracy.Results: Without a marked measurement, the error in length estimation ranged from -61cm to +70cm (-40.7% to 46.7%).The average error was 37.9cm (25.3%).With a marked instrument, the error range was -14cm to +70cm.(-9.3% to +46.7%)The average error reduced to 15.8cm (10.5%).Using a marked instrument increased the time taken from 132.6 seconds to 189.9 seconds, an increase of 43.2%. Conclusion:There is marked variability between surgeons' estimation of length laparoscopically.Using a visual scale on a laparoscopic instrument reduces the error in length estimation at the expense of measurement speed.This could easily be introduced into operative practice.Limitations of the study include the difference in screen size between the simulator and that used for operating, and the lack of elasticity in the material used to simulate bowel.