Impact of 18FFDG-PET/CT and Laparoscopy in Staging of Locally Advanced Gastric Cancer: A Cost Analysis in the Prospective Multicenter PLASTIC-Study.

BACKGROUND: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. MATERIALS AND METHODS: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18FFDG-PET/CT first, then SL, (2) SL only, (3) 18FFDG-PET/CT only, and (4) neither SL nor 18FFDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18FFDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18FFDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). RESULTS: 18FFDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18FFDG-PET/CT to SL increased costs by €1058 per patient; IQR €870-1253 in the sensitivity analysis. CONCLUSIONS: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18FFDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. TRIAL REGISTRATION: NCT03208621. This trial was registered prospectively on 30-06-2017.

Cost-effectiveness of Laparoscopic vs Open Gastrectomy for Gastric Cancer: An Economic Evaluation Alongside a Randomized Clinical Trial.

Importance: Laparoscopic gastrectomy is rapidly being adopted worldwide as an alternative to open gastrectomy to treat gastric cancer. However, laparoscopic gastrectomy might be more expensive as a result of longer operating times and more expensive surgical materials. To date, the cost-effectiveness of both procedures has not been prospectively evaluated in a randomized clinical trial. Objective: To evaluate the cost-effectiveness of laparoscopic compared with open gastrectomy. Design, Setting, and Participants: In this multicenter randomized clinical trial of patients undergoing total or distal gastrectomy in 10 Dutch tertiary referral centers, cost-effectiveness data were collected alongside a multicenter randomized clinical trial on laparoscopic vs open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). A modified societal perspective and 1-year time horizon were used. Costs were calculated on the individual patient level by using hospital registry data and medical consumption and productivity loss questionnaires. The unit costs of laparoscopic and open gastrectomy were calculated bottom-up. Quality-adjusted life-years (QALYs) were calculated with the EuroQol 5-dimension questionnaire, in which a value of 0 indicates death and 1 indicates perfect health. Missing questionnaire data were imputed with multiple imputation. Bootstrapping was performed to estimate the uncertainty surrounding the cost-effectiveness. The study was conducted from March 17, 2015, to August 20, 2018. Data analyses were performed between September 1, 2020, and November 17, 2021. Interventions: Laparoscopic vs open gastrectomy. Main Outcomes and Measures: Evaluations in this cost-effectiveness analysis included total costs and QALYs. Results: Between 2015 and 2018, 227 patients were included. Mean (SD) age was 67.5 (11.7) years, and 140 were male (61.7%). Unit costs for initial surgery were calculated to be €8124 (US $8087) for laparoscopic total gastrectomy, €7353 (US $7320) for laparoscopic distal gastrectomy, €6584 (US $6554) for open total gastrectomy, and €5893 (US $5866) for open distal gastrectomy. Mean total costs after 1-year follow-up were €26 084 (US $25 965) in the laparoscopic group and €25 332 (US $25 216) in the open group (difference, €752 [US $749; 3.0%]). Mean (SD) QALY contributions during 1 year were 0.665 (0.298) in the laparoscopic group and 0.686 (0.288) in the open group (difference, -0.021). Bootstrapping showed that these differences between treatment groups were relatively small compared with the uncertainty of the analysis. Conclusions and Relevance: Although the laparoscopic gastrectomy itself was more expensive, after 1-year follow-up, results suggest that differences in both total costs and effectiveness were limited between laparoscopic and open gastrectomy. These results support centers' choosing, based on their own preference, whether to (de)implement laparoscopic gastrectomy as an alternative to open gastrectomy.

The Introduction of Laparoscopic Colorectal Surgery: Can It Improve Hospital Economics?

INTRODUCTION: Clinical benefits of laparoscopic surgery are well established, but evidence for financial benefits is limited. This study aimed to compare the financial impact of the introduction of laparoscopic colorectal surgery. METHODS: This study included patients who underwent colorectal surgery between January 2010 and 2015. We collected a range of financial data and divided the patients into 2 groups. Primary outcome was total cost defined by surgical-related costs. RESULTS: A total of 1,246 patients were included, of which 440 surgeries were performed laparoscopically. The total median cost of laparoscopy was higher compared to open surgery (EUR 4,665 vs. EUR 4,268, p = 0.001). Laparoscopy was associated with higher equipment costs (EUR 857 vs. EUR 232, p < 0.001), longer operating time (3.2 vs. 2.5 hours, p < 0.001), and more readmissions (10.9 vs. 8.5%, p < 0.001). However, after adjusting for heterogeneity, no difference was found in total cost. Surgical-related costs were counterbalanced by lower costs associated with shorter median hospital stay (6 vs. 9 days, p < 0.001), less morbidity (37.3 vs. 55.1%, p < 0.001), and less mortality (1.8 vs. 5.6%, p = 0.013) for laparoscopy. CONCLUSION: During the introduction of laparoscopy for colorectal surgery, no significant differences were found in total cost between laparoscopic and open colorectal surgery. However, favorable postoperative outcomes were achieved with laparoscopic surgery.

Oncological Outcomes and Hospital Costs of the Treatment in Patients With Rectal Cancer: Watch-and-Wait Policy and Standard Surgical Treatment.

BACKGROUND: Little is known about the costs of the current treatment strategy in locally advanced rectal cancer, in which patients with a clinical complete response after chemoradiotherapy are treated in a watch-and-wait policy. OBJECTIVE: The aim of this study is to present the oncological outcome and hospital costs of patients with a complete response after chemoradiotherapy (watch-and-wait policy) and patients with an incomplete response after chemoradiotherapy (total mesorectal excision). DESIGN: This was a cohort study. SETTINGS: This study was conducted at an academic and a nonacademic hospital. PATIENTS: Patients with locally advanced rectal cancer received either a watch-and-wait policy or total mesorectal excision depending on their clinical response to chemoradiotherapy. INTERVENTIONS: Watch-and-wait policy and total mesorectal excision were the treatments applied. MAIN OUTCOME MEASURES: The primary outcomes measured were overall, local recurrence-free, and distant metastasis-free survival and hospital costs over a 2-year follow-up period. RESULTS: A total of 292 patients with locally advanced rectal cancer were included. Mean age was 65.1 years, and 64.7% were men. One hundred five patients were included in the watch-and-wait subgroup, and 187 patients were in the total mesorectal excision subgroup. Both subgroups showed good oncological outcomes. Hospital costs consisted of 5 categories: costs of primary surgery, costs of adjuvant chemotherapy, costs of examinations, costs of additional surgery, and costs of treatment of regrowth/metastasis. The mean costs per patient were &OV0556;6713 (watch-and-wait subgroup) and &OV0556;17,108 (total mesorectal excision subgroup) over the first 2 years. LIMITATIONS: This study was limited by the following: costs were only from a hospital perspective, follow-up was 2 years, the study was retrospective in part, and there was no comparative study. CONCLUSIONS: Overall survival was good in both subgroups and comparable to literature. The mean costs per patient differ between the watch-and-wait subgroup (&OV0556;6713) and the total mesorectal excision subgroup (&OV0556;17,108). No comparison between the groups could be made. Based on the results of this study, the current strategy, where patients with a clinical complete response are treated in a watch-and-wait policy, and patients with an incomplete response are treated with total mesorectal excision, is likely to be (cost)saving. See Video Abstract at http://links.lww.com/DCR/B177. RESULTADOS ONCOLÓGICOS Y COSTOS HOSPITALARIOS EN EL TRATAMIENTO DE PACIENTES CON CANCER DE RECTO: ACTITUD DE ESPERA-VIGILANCIA Y TRATAMIENTO QUIRÚRGICO ESTANDARD: Se sabe poco sobre el costo del tratamiento actual en casos de cancer de recto localmente avanzado, cuando se aplica una política de vigilancia y espera en aquellos pacientes que presentan una respuesta clínica completa después de radio-quimioterapia.El propósito final del presente estudio es dar a conocer el resultado oncológico y los costos hospitalarios de los pacientes que presentan una respuesta clínica completa después de radio-quimioterapia (actitud de vigilancia-espera) y los pacientes con una respuesta incompleta después luego de radio-quimioterapia (excisión total del mesorrecto-ETM).Estudio de cohortes.Hospitales académicos y no académicos.Todos aquellos pacientes tratados por un cáncer de recto localmente avanzado y que fueron seguidos con una política de vigilancia y espera o la ETM, en función de la respuesta clínica a la radio-quimioterapia.Políticas de vigilancia-espera, excisión total del mesorrecto.Sobrevida global libre de recurrencia local, metástasis a distancia, sobrevida libre de enfermedad y costos hospitalarios durante un período de seguimiento de dos años.Se incluyeron 292 pacientes diagnosticados de cancer de recto localmente avanzado. La edad media fue de 65,1 años, 64,7% eran de sexo masculino. Se incluyeron 105 pacientes en el subgrupo de vigilancia-espera, y 187 en el subgrupo de excisión total del mesorrecto. Ambos subgrupos mostraron optimos resultados oncológicos. Los costos hospitalarios se dividieron en cinco categorías: costos de cirugía primaria; costos de quimioterapia adyuvante; costos de exámenes; costos de cirugía adicional; y costos del tratamiento de rebrote / metástasis. Los costos medios por paciente fueron de &OV0556; 6.713 (subgrupo de espera-vigilancia) y &OV0556; 17.108 (subgrupo de excisión total del mesorrecto) durante los primeros dos años.Analisis de costos desde una perspectiva hospitalaria durante un seguimiento de dos años, estudio parcialmente retrospectivo, no comparativo.La sobrevida general fue optima en ambos subgrupos y comparable con la literatura. El costo promedio por paciente difiere entre el subgrupo de vigilancia y espera (&OV0556; 6.713) con el subgrupo de la ETM(&OV0556; 17.108). No se pudieron comparar definitivamente ambos grupos. Basados en los resultados del presente estudio, es probable que la estrategia actual, en la que los pacientes con respuesta clínica completa sean tratados con una política de vigilancia y espera, presenten muy probablemente un cierto ahorro en el costo con relación a los pacientes con una respuesta incompleta tratados con excisión total del mesorrecto. Consulte Video Resumen en http://links.lww.com/DCR/B177. (Traducción-Dr. Xavier Delgadillo).

Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

BACKGROUND: For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. METHODS: The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. DISCUSSION: In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient. TRIAL REGISTRATION: NCT02248519.

Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II-trial): study protocol for a randomised controlled trial.

BACKGROUND: The use of lLaparoscopic liver resection in terms of time to functional recovery, length of hospital stay (LOS), long-term abdominal wall hernias, costs and quality of life (QOL) has never been studied in a randomised controlled trial. Therefore, this is the subject of the international multicentre randomised controlled ORANGE II trial. METHODS: Patients eligible for left lateral sectionectomy (LLS) of the liver will be recruited and randomised at the outpatient clinic. All randomised patients will undergo surgery in the setting of an ERAS programme. The experimental design produces two randomised arms (open and laparoscopic LLS) and a prospective registry. The prospective registry will be based on patients that cannot be randomised because of the explicit treatment preference of the patient or surgeon, or because of ineligibility (not meeting the in- and exclusion criteria) for randomisation in this trial. Therefore, all non-randomised patients undergoing LLS will be approached to participate in the prospective registry, thereby allowing acquisition of an uninterrupted prospective series of patients. The primary endpoint of the ORANGE II trial is time to functional recovery. Secondary endpoints are postoperative LOS, percentage readmission, (liver-specific) morbidity, QOL, body image and cosmetic result, hospital and societal costs over 1 year, and long-term incidence of incisional hernias. It will be assumed that in patients undergoing laparoscopic LLS, length of hospital stay can be reduced by two days. A sample size of 55 patients in each randomisation arm has been calculated to detect a 2-day reduction in LOS (90% power and α = 0.05 (two-tailed)).The ORANGE II trial is a multicenter randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing LLS within an enhanced recovery ERAS programme. TRIAL REGISTRATION: ClinicalTrials.gov NCT00874224.

Prospective volumetric assessment of the liver on a personal computer by nonradiologists prior to partial hepatectomy.

BACKGROUND: A small remnant liver volume is an important risk factor for posthepatectomy liver failure. ImageJ and OsiriX® are both free, open-source image processing software packages. The aim of the present study was to compare ImageJ and OsiriX® in performing prospective computed tomography (CT) volumetric analysis of the liver on a personal computer (PC) in patients undergoing major liver resection. METHODS: Patients scheduled for a right hemihepatectomy were eligible for inclusion. Two surgeons and one surgical trainee measured volumes of total liver, tumor, and future resection specimen prospectively with ImageJ and OsiriX®. A radiologist also measured these volumes with CT scanner-linked Aquarius iNtuition® software. Resection volumes were compared with the actual weights of the liver specimens removed during surgery, and differences between the measured liver volumes were analyzed. RESULTS: A total of 15 patients (8 men, 7 women) with a median age of 63 years (48-79 years) were included. There was a significant correlation between the measured weights of resection specimens and the volumes calculated prospectively with ImageJ and OsiriX® (r=0.89; r=0.83, respectively). There was also a significant correlation between the volumes measured with radiological software iNtuition® and the volumes measured with ImageJ and OsiriX® (r=0.93; r=0.95, respectively). CONCLUSIONS: There were no major differences in total liver volumes, resection volumes, or tumour volumes for these three software packages. Prospective hepatic CT volumetry with ImageJ or OsiriX® is reliable and can be accurately used on a PC by nonradiologists. ImageJ and OsiriX® yield results comparable to the radiological software iNtuition®.