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  • Oxford University Press (OUP)  (10)
  • Rosman, Camiel  (10)
  • 1
    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
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  • 2
    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
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  • 3
    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
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  • 4
    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
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  • 5
    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
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  • 6
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2018
    In:  Diseases of the Esophagus Vol. 31, No. Supplement_1 ( 2018-09-01), p. 2-2
    In: Diseases of the Esophagus, Oxford University Press (OUP), Vol. 31, No. Supplement_1 ( 2018-09-01), p. 2-2
    Abstract: Ivor Lewis totally minimally invasive esophagectomy (TMIE) is associated with a long learning curve and high learning associated morbidity. Factors that are associated with a shorter learning curve and less associated morbidity have not been investigated from clinical data. The aim of this study was to investigate whether there is a relationship between hospital volume and the length of the learning curve and learning associated morbidity. Methods Prospectively collected data were retrospectively analyzed of all consecutive patients undergoing Ivor Lewis TMIE in expert centers in Sweden, Denmark and the Netherlands. The primary outcome parameter was anastomotic leakage requiring reoperation or reintervention. Learning curves were plotted using weighted moving average and CUSUM analysis was used to determine after how many cases the plateau was reached. Learning associated morbidity was calculated with area under the curve analysis. The length of the learning curve and learning associated morbidity were compared between hospitals  〈  50 procedures per year (normal volume) and hospitals performing  〉  50 procedures (high volume) per year. Results Nine centers participated and 906 patients were included. The mean number of Ivor Lewis TMIE performed per center per year was 41 (range 22–60). The overall length of the learning curve was 136 cases and this was 148 cases in the normal volume group versus 122 cases in the high volume group. Learning associated anastomotic leakage occurred in 10 patients (7.4% of all patients operated during the learning curve) and this was 13 patients (8.5%) in the normal volume group versus 6 patients (5.2%) in the high volume group. Conclusion Learning curves were shorter and learning associated morbidity was lower in centers with higher case volume. This is the first study demonstrating this effect from clinical data. Patient safety can be significantly compromised during surgical learning curves and probably, patient safety can be increased if surgeons learn technically challenging procedures in higher volume centers. Our data can guide the design of implementation programs for technically challenging procedures. This abstract was submitted on behalf of the esophagectomy learning curve collaborative group. 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
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  • 7
    In: Diseases of the Esophagus, Oxford University Press (OUP), Vol. 31, No. Supplement_1 ( 2018-09-01), p. 142-142
    Abstract: In operable patients suffering from esophageal cancer, the percentage of patients without metastatic lymph nodes found after neoadjuvant chemoradiotherapy (nCRT) is 69%. Extensive lymph node dissections during esophagectomy may be omitted or minimized in these patients, reducing associated morbidity. Recently, MRI with ultrasmall superparamagnetic iron oxide nanoparticles (USPIO, ferumoxtran-10) has been reintroduced to detect metastatic lymph nodes in prostate cancer. The aim of this study is to assess the feasibility of USPIO-MRI to detect loco-regional lymph node metastases in patients with esophageal cancer. Methods USPIO-nanoparticles are intravenously infused 24 to 36 hours before MRI. USPIO-enhanced MRI is performed before and after nCRT. After nCRT, patients are scanned under general anesthesia immediately prior to surgery in the MR system of the hybrid MITeC operation room with controlled mechanical ventilation. During controlled prolonged apneu, a four-minute iron-sensitive MRI acquisition is used to visualize suspicious esophageal lymph nodes without motion artefacts. Resected specimens, still containing USPIO, are measured ex-vivo in a preclinical 7T MR system before histopathological examination. A radiological assessment of the presence of suspicious lymph nodes in-vivo is matched to the ex-vivo nodes on preclinical MRI, providing the ground truth for the presence of metastases. Results Currently, three patients were included in the study of which one patient has been examined before and after nCRT. MRI under anesthesia prior to surgery with controlled mechanical ventilation was possible resulting in a clinically relevant spatial resolution to visualize possible malignant lymph nodes. Suspicious nodes were identified and could be matched using corresponding anatomical landmarks to the ex-vivo MRI, which showed good visual agreement with esophageal specimen after resection. Conclusion A successful method was proposed to validate USPIO-enhanced MRI to detect metastatic lymph nodes in patients with esophageal cancer. Matching ex-vivo USPIO-MRI images with histopathology results provides direct information for validation of in vivo USPIO-MRI and characteristics of loco-regional lymph nodes. Final results on the feasibility of USPIO-MRI to detect metastatic lymph nodes after nCRT are still awaited. Feasibility and preliminary values of the accuracy of the technique are the starting point for a phase two study. 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
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  • 8
    In: British Journal of Surgery, Oxford University Press (OUP), Vol. 108, No. Supplement_8 ( 2021-11-24)
    Abstract: To determine if prophylactic mesh placement is an effective, safe, and cost-effective procedure to prevent parastomal hernia (PSH) formation in the long term. Material and Methods In this multicenter superiority trial patients undergoing formation of a permanent colostomy were randomly assigned to either retromuscular mesh reinforcement or conventional colostomy formation. The primary endpoint was the incidence of a PSH after 5 years. Secondary endpoints were morbidity, mortality, quality of life and cost-effectiveness. Results A total of 150 patients were randomly assigned to the mesh group (n = 72) or non-mesh group (n = 78). For the long term follow up, we could analyse 113 patients since 37 patients were lost to follow-up. After a median follow-up of 60 months (IQR 48.6 – 64.4), 49 patients developed a PSH, 20 (27.8%) in the mesh group and 29 (37.2%) in the non-mesh group (p = 0.22; 95% CI -24 – 5.5). A total of 25 patients developed an incisional hernia, seven in the mesh group (10.4%) versus 18 in the non-mesh group (27.2%) (p = 0.013, 95% CI 3.5 – 30.0). No relevant differences were found in quality of life or cost-effectiveness between both study group. Conclusions Use of a prophylactic retromuscular mesh at the ostomy site delays but not reduces the incidence of PSH after 5 years of follow-up. It leads to less severe PSH according to the EHS and MM classification with fewer repairs needed. Furthermore it causes patients to have fewer stoma related complications necessitating change of appliances and it is safe without any adverse events or increase in morbidity.
    Type of Medium: Online Resource
    ISSN: 0007-1323 , 1365-2168
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2006309-X
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  • 9
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2023
    In:  British Journal of Surgery Vol. 110, No. 9 ( 2023-08-11), p. 1096-1099
    In: British Journal of Surgery, Oxford University Press (OUP), Vol. 110, No. 9 ( 2023-08-11), p. 1096-1099
    Type of Medium: Online Resource
    ISSN: 0007-1323 , 1365-2168
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 10
    In: Diseases of the Esophagus, Oxford University Press (OUP), Vol. 33, No. 8 ( 2020-08-03)
    Abstract: Minimally invasive esophagectomy is increasingly performed for the treatment of esophageal cancer, but it is unclear whether hybrid minimally invasive esophagectomy (HMIE) or totally minimally invasive esophagectomy (TMIE) should be preferred. The objective of this study was to perform a meta-analysis of studies comparing HMIE with TMIE. A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Articles comparing HMIE and TMIE were included. The Newcastle–Ottawa scale was used for critical appraisal of methodological quality. The primary outcome was pneumonia. Sensitivity analysis was performed by analyzing outcome for open chest hybrid MIE versus total TMIE and open abdomen MIE versus TMIE separately. Therefore, subgroup analysis was performed for laparoscopy-assisted HMIE versus TMIE, thoracoscopy-assisted HMIE versus TMIE, Ivor Lewis HMIE versus Ivor Lewis TMIE, and McKeown HMIE versus McKeown TMIE. There were no randomized controlled trials. Twenty-nine studies with a total of 3732 patients were included. Studies had a low to moderate risk of bias. In the main analysis, the pooled incidence of pneumonia was 19.0% after HMIE and 9.8% after TMIE which was not significantly different between the groups (RR: 1.46, 95% CI: 0.97–2.20). TMIE was associated with a lower incidence of wound infections (RR: 1.81, 95% CI: 1.13–2.90) and less blood loss (SMD: 0.78, 95% CI: 0.34–1.22) but with longer operative time (SMD:-0.33, 95% CI: −0.59—-0.08). In subgroup analysis, laparoscopy-assisted HMIE was associated with a higher lymph node count than TMIE, and Ivor Lewis HMIE was associated with a lower anastomotic leakage rate than Ivor Lewis TMIE. In general, TMIE was associated with moderately lower morbidity compared to HMIE, but randomized controlled evidence is lacking. The higher leakage rate and lower lymph node count that was found after TMIE in sensitivity analysis indicate that TMIE can also have disadvantages. The findings of this meta-analysis should be considered carefully by surgeons when moving from HMIE to TMIE.
    Type of Medium: Online Resource
    ISSN: 1442-2050
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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