Centralized Implementation of accurate and efficient preoperative staging using multislice CT, endoultrasonographic fine needle biopsy (EUS-FNA) and positron emission tomography (FDG-PET) in esophageal cancer patients: Cimple study
Projectomschrijving
Precies vaststellen hoe ver bij iemand met slokdarmkanker de ziekte gevorderd is, is een ingewikkeld karwei. De uitvoering van de onderzoeken die hiervoor nodig zijn en het interpreteren van de uitkomsten van die onderzoeken vergen speciale kennis en ervaring. Om die reden is het wenselijk de (aanvullende) diagnostiek bij slokdarmkanker per regio te concentreren in één ziekenhuis. In Groningen is onderzocht of in de regio Noord-Oost Nederland hiertoe bereidheid bestaat onder de artsen; wat het effect is van het concentreren van de diagnostiek en de geleverde zorg en wat het effect is op de kosten. De bereidheid tot regionale concentratie bleek groot (87%). In een pilotstudie met 59 patiënten bleek de (centrale) diagnostiek binnen 10 dagen uitgevoerd te kunnen worden. Het aantal patiënten dat onnodig chirurgisch behandeld werd nam af van 18% naar 10%. Met name dit laatste leidt tot een flinke kostenbesparing.
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Eindverslag
Samenvatting van de aanvraag
. implementation objective: In an ongoing cost-effectiveness study (ZonMw 945-11-002), the combination of PET with FDG, multislice CT and EUS-FNA, showed to be the optimal staging in esophageal cancer patients. This complex staging and therapy in these patients require long learning curves and adequate equipment which is not available in most general hospitals. Centralization of staging is therefore desirable, but the willingness of participation among specialists in the Comprehensive Cancer Center North Netherlands (IKN) region has to be evaluated. The feasibility of centralized staging in a one-week period and its cost-effectiveness will also be assessed. Objective: To determine the desirability, feasibility and cost-effectiveness of centralized diagnostic work-up, preferably in a one-week target, compared to current staging in general hospitals. . Research questions: - What is the willingness of specialists in the IKN region to participate in a centralized diagnostic work-up of esophageal cancer? - Is centralized staging feasible within one week? - What is the cost-effectiveness of the new strategy as compared to the current? - What is the effect on quality of care from the perspective of the patient? . design: The support for implementation of a centralized staging strategy and desirable conditions will be explored. In a pilot study of 25-30 patients, the feasibility and cost-effectiveness of diagnostic work-up within one week will be analyzed. Data from the study ZonMw 945-11-002/015 will be supplemented by additional retrospective data and used to support the economic evaluation. The acceptability of the new strategy and patient satisfaction will be assessed in the pilot study. . study population(s)/ datasets: The explorative study is aimed at surgeons and gastroenterologists in the IKN region involved in the work-up and management of esophageal cancer patients. The centralized strategy employed during the pilot study is intended for all operable esophageal cancer patients in the region. . intervention to be implemented: Intervention consists of optimal staging in "centers of excellence" based on dedicated tools (EUS-FNA and PET/multislice CT) resulting in treatment recommendation, preferably within one week after referral. Surgeons and gastroenterologists in general hospitals in the IKN region will be instructed to refer patients with esophageal cancer without performing further diagnostic interventions. At the University Hospital, patients will be staged by a dedicated team of specialists. Diagnostic modalities will be performed within 48 hours with evaluation and multidisciplinary expert treatment recommendations within one week after presentation. . implementation activities/strategy: The feasibility of centralized staging depends on the willingness of specialists in the general hospitals and the ability to perform the staging protocol within an acceptable time. The IKN management and several general hospitals have promised cooperation. Exploration will be expanded by questionnaires, exchange of information and informal discussions "how to do better". Multifaceted educational program will lead to broad consensus on appropriate diagnostic and treatment strategies in the IKN region. After following the diagnostic protocol in a pilot period of 10 to 12 months, including a total of 25-30 patients, the practicability and effectiveness will be evaluated. Workload and overall duration of the diagnostic process will be assessed and the protocol will be adapted if necessary. . outcome measures and process indicators: - The percentage of participating institutes in the IKN region. - The number of referred patients. - The number of days between referral and diagnosis during the feasibility study. - Adherence to the protocol for centralized staging. - The number of correctly staged patients in the baseline strategy and the centralized strategy - The number of prevented futile explorations. - Cost-effectiveness of centralized staging. - Quality of care perceived by patients participating in the feasibility study. . power/data analysis: No formal power analysis was performed for this explorative study. Only descriptive statistics will be employed. With the proposed number of patients in the feasibility study, effectiveness parameters can be estimated with sufficient precision. . economic evaluation: Economic evaluation will be aimed at the determination of the cost-effectiveness of centralized staging versus the current situation. Direct medical costs of diagnostic procedures will be assessed and compared to the number of correctly staged patients in both situations. . time schedule: 0-4 months: preparation, consultation, organizing meetings within the region and coordination between the participants. Months 4-16: pilot feasibility study in the northern region; months 16-20 completing data and analysis, feedback to the region, publication of results in (inter)national scientific journals and meetings.