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  • 1
    In: Diseases of the Esophagus, Oxford University Press (OUP), Vol. 34, No. Supplement_1 ( 2021-09-17)
    Abstract: Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer. Methods In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina) or GEJ cancer planned for curative resection were recruited. Eligible patients were randomly assigned (1:1) to either Ivor Lewis MIE or McKeown MIE. The primary endpoint was anastomotic leakage (AL) requiring endoscopic, radiologic or surgical intervention. Secondary outcome parameters were overall AL rate, postoperative complications, length of stay and mortality. Results A total of 262 patients were randomly assigned to Ivor Lewis MIE (n = 130) or McKeown MIE (n = 132). Seventeen patients were excluded due to not meeting inclusion criteria (n = 2), physical unfitness for surgery (n = 3), patients’ choice (n = 3), interval metastases (n = 5) or peroperative metastases (n = 4). AL necessitating reintervention occurred in 15 (12.3%) of 122 patients after Ivor Lewis MIE and in 39 (31.7%) of 123 patients after McKeown MIE (RR 0.39, 95%CI 0.22–0.65). Severe complications (Clavien-Dindo ≥3b) were observed in 10.7% after Ivor Lewis MIE and in 22.0% after McKeown MIE (RR 0.49, 95%CI 0.25–0.88). Conclusion This study provides evidence for a lower rate of AL requiring reintervention after Ivor Lewis MIE compared to McKeown MIE for patients with mid to distal esophageal or GEJ cancer.
    Type of Medium: Online Resource
    ISSN: 1120-8694 , 1442-2050
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2004949-3
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  • 2
    In: International Journal of Cancer, Wiley, Vol. 149, No. 3 ( 2021-08), p. 635-645
    Abstract: What's new? While surgical resection is critical in the treatment of primary solid tumors, resection at tumor margins remains problematic, with inadequately resected margins facilitating tumor recurrence. In this systematic review, the authors collected information on novel imaging techniques applied to the intraoperative assessment of tumor margins across cancer types. A total of 16 groups of techniques were identified, with many in early stages of clinical application. Following comparison, no single technique was clearly superior in clinical feasibility or diagnostic accuracy. The review highlights the evolving nature of imaging techniques for intraoperative margin assessment and identifies opportunities and limitations in the field.
    Type of Medium: Online Resource
    ISSN: 0020-7136 , 1097-0215
    URL: Issue
    RVK:
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 218257-9
    detail.hit.zdb_id: 1474822-8
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  • 3
    In: Trials, Springer Science and Business Media LLC, Vol. 17, No. 1 ( 2016-12)
    Type of Medium: Online Resource
    ISSN: 1745-6215
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2016
    detail.hit.zdb_id: 2040523-6
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  • 4
    Online Resource
    Online Resource
    BMJ ; 2021
    In:  BMJ Surgery, Interventions, & Health Technologies Vol. 3, No. 1 ( 2021-02), p. e000042-
    In: BMJ Surgery, Interventions, & Health Technologies, BMJ, Vol. 3, No. 1 ( 2021-02), p. e000042-
    Abstract: To develop an interactive tool that estimates what potential benefits are needed for the robot to provide value for money when compared with endoscopic or open surgical interventions. Design A generic online interactive tool was developed to analyze the (health) effects needed to compensate for the additional costs of using a surgical robotic system from a healthcare perspective. The application of the tool is illustrated with a hypothetical new surgical robotic platform. A synthesis of evidence from different sources was used combined with interviews with surgeons. Setting Flexible tool that can be adapted to flexible settings. Participants Any hospital patient group for which robotic, endoscopic or open surgical procedures may be considered as appropriate treatment alternatives (eg, urology, gynecology, and so on). Intervention Robotically assisted surgical interventions. Comparator Endoscopic or open surgical interventions. Main outcome measures Thresholds of how much (health) effect is needed for robot-assisted surgery to provide value for money and to become cost-effective. Results The utilization rate of the surgical robotic system and a reduction in complications appeared to be important aspects in determining the value for money. To become cost-effective, it was deemed important for new surgical robotic systems to have added clinical benefit and become less costly than the current system. Conclusions This paper and its assisting interactive tool can be used by clinicians, researchers, and policymakers to gain insight in the benefit needed to provide value for money when using a (new) surgical robotic system or, when the effects are known or can be estimated, to assess the value for money for a specific indication. For robotic surgery to provide most value for money, we recommend assessing for each indication whether the necessary effects seem achievable.
    Type of Medium: Online Resource
    ISSN: 2631-4940
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2973060-0
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  • 5
    In: Diseases of the Esophagus, Oxford University Press (OUP), Vol. 31, No. Supplement_1 ( 2018-09-01), p. 99-99
    Abstract: Anastomotic leakage affects up to 30% of patients after esophagectomy each year and leads to considerable morbidity and mortality. The aim of this study was to determine which treatment for anastomotic leakage after esophagectomy has the best clinical outcome, based on currently available literature. Methods A systematic literature search was performed in Medline, Embase and Web of Science until April 2017. All studies reporting on the treatment of anastomotic leakage following esophagectomy with gastric tube reconstruction for esophageal or cardia cancer were included. The primary outcome parameter was postoperative mortality. Methodological quality was assessed by the Newcastle-Ottawa Quality Assessment Scale. Results Nineteen retrospective cohort studies including 273 patients were identified. Methodological quality of all studies was poor to moderate. Regarding intrathoracic anastomotic leakages, mortality rates in the conservative, endoscopic stent, endoscopic drainage, endoscopic vacuum assisted closure system and surgery treatment group were 14%, 8%, 8%, 0%, and 50%, respectively. Regarding cervical anastomotic leakages, mortality rates in the conservative, endoscopic stent and endoscopic dilatation group were 8%, 29%, and 0%, respectively. Conclusion Due to small cohorts, heterogeneity between studies, and lack of data regarding leakage characteristics, no evidence supporting one treatment for anastomotic leakage after esophagectomy was found. A severity score based on leakage characteristics instead of treatment given is essential for determining the optimal treatment of anastomotic leakage. A prospective registration study could provide answers to issues as which leakage characteristics determine its severity and which treatment options have the best outcomes for a given anastomotic leakage severity. Disclosure All authors have declared no conflicts of interest.
    Type of Medium: Online Resource
    ISSN: 1120-8694 , 1442-2050
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
    detail.hit.zdb_id: 2004949-3
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  • 6
    In: Diseases of the Esophagus, Oxford University Press (OUP), Vol. 32, No. Supplement_2 ( 2019-11-23)
    Abstract: To define factors associated with more efficient learning after implementation of Ivor Lewis totally minimally invasive esophagectomy (TMIE). Background and Methods It is unknown which factors are associated with more efficient learning after implementation of Ivor Lewis TMIE. Prospectively collected data of 15 European expert centers are retrospectively analyzed. Consecutive patients undergoing Ivor Lewis TMIE are included. The primary outcome is anastomotic leakage and the secondary outcome is textbook outcome (TBO). The pre-defined level of acceptance for anastomotic leakage is set at 8% with a 5% margin. Trends in outcome parameters are plotted using weighted moving average to define when the pre-defined level of acceptance is reached. Outcome trends are compared between groups of hospitals for the following factors: hospital volume, surgeon experience, overall TMIE experience, expert clinic visit, Ivor Lewis TMIE course followed and Ivor Lewis TMIE proctor supervision during implementation. Results This study included 1718 patients. Hospitals with a volume 〉 50 cases per year reached the pre-defined level of acceptance for anastomotic leakage at case 114, hospitals with a volume 〈 50 cases did not reach the pre-defined level of acceptance. Hospitals with surgeon experience 〉 10 years and 〈 10 years reached the pre-defined level of acceptance at case 112 and 135, respectively. Hospitals with overall TMIE experience 〉 50 cases and 〈 50 cases reached the pre-defined level of acceptance at case 45 and 112, respectively. Visiting an expert clinic, followed a TMIE course, or implementation under a proctor’s supervision did not contribute to reaching the level of acceptance earlier. Conclusion Learning curves are shorter and the level of acceptance is reached earlier if Ivor Lewis TMIE is implemented in a high-volume hospital, if the procedure is implemented in a hospital with a surgeon with 〉 10 years of experience, or if the surgeon has experience in other types of TMIE of 〉 50 cases. These findings can inform surgeons and can contribute to formulate evidence-based training programs.
    Type of Medium: Online Resource
    ISSN: 1442-2050
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
    detail.hit.zdb_id: 2004949-3
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  • 7
    In: Diseases of the Esophagus, Oxford University Press (OUP), Vol. 36, No. Supplement_2 ( 2023-08-30)
    Abstract: Minimally Invasive transCervical Esophagectomy (MICE) is a novel transcervical approach to esophagectomy with the possible advantage of decreased pulmonary complications. MICE is in an early stage of introduction in patients which are treated with the McKeown procedure in regular practice. The aim of this study was to provide insight in the potential cost-effectiveness of MICE and its sensitivity to different complications. Methods A decision tree modelled the postoperative outcomes of recurrent laryngeal nerve paresis, anastomotic leakage, pulmonary complications and 30-day mortality. Subsequently, we developed a Markov state transition model to calculate the effects of these input parameters on health outcomes (QALYs) and costs. The results were analysed with a sensitivity analysis and a scenario analysis of a clinical trial of a similar procedure. Results Preventing complications seemed to be effective in reducing hospital costs, but resulted in a limited improvement of health outcomes. Improving 30-day survival demonstrated to have a larger effect on health outcomes. A scenario analysis of data from a clinical trial studying similar procedures resulted in a cost reduction of €2974 and an increase of 0.016 QALYs per patient. Conclusion Reduced healthcare costs and improved health outcomes from reducing complications and 30-day mortality could offset the increased cost of MICE and lead to a cost-effective innovation. We advise close monitoring of short and long term survival outcomes in future studies.
    Type of Medium: Online Resource
    ISSN: 1120-8694 , 1442-2050
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 2004949-3
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  • 8
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2018
    In:  Diseases of the Esophagus Vol. 31, No. Supplement_1 ( 2018-09-01), p. 34-34
    In: Diseases of the Esophagus, Oxford University Press (OUP), Vol. 31, No. Supplement_1 ( 2018-09-01), p. 34-34
    Abstract: Neoadjuvant chemoradiotherapy (nCRT) followed by resection of the tumor with two field lymphadenectomy is a standard treatment for esophageal cancer. After nCRT, however, in more than 70% of patients no lymph node metastases are found, suggesting extensive overtreatment. Tumor-targeted fluorescence imaging is a promising technique to detect lymph node metastases intra-operatively and guide personalized resection. The aim of this study is to identify potential viable tumor markers for fluorescence imaging of lymph node metastases in patients with esophageal adenocarcinoma (EAC). Methods Immunohistochemistry (IHC) was performed on tissue microarrays from EAC’s patients that underwent surgical resection between 2007 and 2016. Patients were subdivided in five groups, non-pretreated patients with and without metastatic lymph nodes, complete responders, partial responders and non-responders after nCRT. Five membranous markers, c-MET, CAIX, EGFR, EpCAM, HER2, and two cytoplasmic markers, VEGF-A and VEGF-A receptor were included. Tumor marker expression was scored on intensity (none (0), slight (1), moderate (2), strong (3)) and the percentage of positive cells (estimation). Threshold for positive detection rate was defined as an intensity of ≥ 2 in more than 10% the cells. Results EpCAM showed the highest expression in metastastic lymph nodes, with a median intensity of 3 (range 2–3) in  〉  70% of the tumor cells. Expression was found in 37 out of 39 EAC’s (95%). VEGF-A and CAIX expression was observed in 28 of 33 (85%) and 10 of 33 (30%) of metastatic lymph nodes and 34 of 39 (87%) and 17 of 39 (44%) in the primary EAC’s, respectively. For the other tumor biomarkers the detection rate ranged between 0 and 11% for metastatic lymph nodes and primary EAC’s. Only EpCAM and VEGF-A showed weak, non-specific staining in the fibrotic tissue. Conclusion High expression rates in primary EAC and metastatic lymph nodes were observed using immunohistochemical antibodies for EpCAM, VEGF-A and CA-IX, making these clinically relevant viable EAC tumor markers. A phase 1 dose finding study targeting VEGF-A by Bevacizumab-800-CW in patient with EAC is in preparation. Disclosure All authors have declared no conflicts of interest.
    Type of Medium: Online Resource
    ISSN: 1120-8694 , 1442-2050
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2018
    detail.hit.zdb_id: 2004949-3
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  • 9
    In: European Journal of Surgical Oncology, Elsevier BV, Vol. 46, No. 2 ( 2020-02), p. e153-
    Type of Medium: Online Resource
    ISSN: 0748-7983
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
    detail.hit.zdb_id: 2002481-2
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  • 10
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 4509-4509
    Abstract: 4509 Background: Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer. Methods: In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina) or GEJ cancer planned for curative resection were recruited. Eligible patients were randomly assigned (1:1) to either Ivor Lewis MIE or McKeown MIE. The primary endpoint was anastomotic leakage (AL) requiring endoscopic, radiologic or surgical intervention. Secondary outcome parameters were overall AL rate, postoperative complications, length of stay and mortality. Results: A total of 262 patients were randomly assigned to Ivor Lewis MIE (n = 130) or McKeown MIE (n = 132). Seventeen patients were excluded from the trial due to not meeting inclusion criteria (n = 2), physical unfitness for surgery (n = 3), patients’ choice (n = 3), interval metastases (n = 5) or peroperative metastases (n = 4). AL necessitating reintervention occurred in 15 (12.3%) of 122 patients after Ivor Lewis MIE and in 39 (31.7%) of 123 patients after McKeown MIE (relative risk 0.39, 95% CI 0.22-0.65; risk difference 19.4%, 95% CI 7.9%-31.8%). Overall AL rate was 12.3% after Ivor Lewis MIE and 34.1% after McKeown MIE. Severe complications (Clavien-Dindo ≥ 3b) were observed in 10.7% after Ivor Lewis MIE and in 22.0% after McKeown MIE. Pleural effusion requiring drainage occurred in 9.8% of patients after Ivor Lewis MIE and 21.1% of patients after McKeown MIE. RLN palsy rate was 0% after Ivor Lewis MIE and 7.3% after McKeown MIE. Median length of hospital stay was 10 days (IQR 8 – 15 days) after Ivor Lewis MIE and 12 days (IQR 9 – 18 days) after McKeown MIE. ICU length of stay and mortality rates were comparable between groups. Conclusions: These findings provide evidence for a lower rate of AL requiring reintervention after Ivor Lewis MIE compared to McKeown MIE for patients with mid to distal esophageal or GEJ cancer. Clinical trial information: NTR4333 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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