Effects of shared medical appointments on quality of life and cost-effectiveness for patients with a chronic neuromuscular disease. Study protocol of a randomized controlled trial

Contains fulltext : 96862.pdf (publisher's version ) (Open Access)BACKGROUND: Shared medical appointments are a series of one-to-one doctor-patient contacts, in presence of a group of 6-10 fellow patients. This group visits substitute the annual control visits of patients with the neurologist. The same items attended to in a one-to-one appointment are addressed. The possible advantages of a shared medical appointment could be an added value to the present management of neuromuscular patients. The currently problem-focused one-to-one out-patient visits often leave little time for the patient's psychosocial needs, patient education, and patient empowerment. METHODS/DESIGN: A randomized, prospective controlled study (RCT) with a follow up of 6 months will be conducted to evaluate the clinical and cost-effectiveness of shared medical appointments compared to usual care for 300 neuromuscular patients and their partners at the Radboud University Nijmegen Medical Center. Every included patient will be randomly allocated to one of the two study arms. This study has been reviewed and approved by the medical ethics committee of the region Arnhem-Nijmegen, The Netherlands. The primary outcome measure is quality of life as measured by the EQ-5D, SF-36 and the Individualized neuromuscular Quality of Life Questionnaire. The primary analysis will be an intention-to-treat analysis on the area under the curve of the quality of life scores. A linear mixed model will be used with random factor group and fixed factors treatment, baseline score and type of neuromuscular disease. For the economic evaluation an incremental cost-effectiveness analysis will be conducted from a societal perspective, relating differences in costs to difference in health outcome. Results are expected in 2012. DISCUSSION: This study will be the first randomized controlled trial which evaluates the effect of shared medical appointments versus usual care for neuromuscular patients. This will enable to determine if there is additional value of shared medical appointments to the current therapeutical spectrum. When this study shows that group visits produce the alleged benefits, this may help to increase the acceptance of this innovative and creative way of using one of the most precious resources in health care more efficiently: time. TRIAL REGISTRATION: DutchTrial Register http://www.trialregister.nlNTR1412

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

Roboterassistierte minimal-invasive Ösophagektomie

Die Ösophagolymphadenektomie ist der Eckpfeiler der multimodalen Behandlung des resektablen Ösophaguskarzinoms. Der chirurgische Zugang erfolgt bevorzugt transthorakal, mit 2‑Feld-Lymphadenektomie und Rekonstruktion durch Magenhochzug. Für einen minimal-invasiven Ansatz wurde gezeigt, dass er die postoperativen Komplikationen reduziert und die Lebensqualität erhöht. Die roboterassistierte minimal-invasive Ösophagektomie (RAMIE) wurde mit dem Ziel entwickelt, dieses komplexe thorakoskopische Verfahren zu erleichtern. Die Sicherheit der RAMIE ist belegt, die onkologischen Ergebnisse sind gut, die Morbidität wird verringert. Die Anwendung eröffnet neue Indikationen für die kurative chirurgische Behandlung von Patienten mit T4b-Tumoren, Tumoren im oberen Mediastinum und Lymphknotenmetastasen nach neoadjuvanter Therapie

Robot-assisted minimally invasive esophagectomy

Esophagolymphadenectomy is the cornerstone of multimodality treatment for resectable esophageal cancer. The preferred surgical approach is transthoracic, with a two-field lymph node dissection and gastric conduit reconstruction. A minimally invasive approach has been shown to reduce postoperative complications and increase quality of life. Robot-assisted minimally invasive esophagectomy (RAMIE) was developed to facilitate this complex thoracoscopic procedure. RAMIE has been shown to be safe with good oncologic results and reduced morbidity. The use of RAMIE opens new indications for curative surgery in patients with T4b tumors, high mediastinal tumors, and lymph node metastases after neoadjuvan

Worldwide trends in surgical techniques in the treatment of esophageal and gastroesophageal junction cancer

The aim of this study was to evaluate the worldwide trends in surgical techniques for esophageal cancer surgery by comparing it to our survey from 2007. In addition, new questions were added for gastroesophageal junction (GEJ) cancer. An international survey on surgery of esophageal and GEJ cancer was performed among surgical members of the International Society for Diseases of the Esophagus, the World Organization for Specialized Studies on Disease of the Esophagus, the International Gastric Cancer Association. Also, surgeons from personal networks were contacted. The participants filled out a web based questionnaire about surgical strategies for esophageal and gastroesophageal cancer. The overall response rate was 478/1147 (42%). The respondents represented 49 different countries and 6 different continents. The annual cumulative number of esophageal and gastric resections per surgeon was low (≤11) in 11%, medium (11-21) in 17%, and high (≥21) in 72% of respondents. In a subgroup analysis of esophageal surgeons the number of high volume surgeons increased from 45 to 54% over the past 7 years. The preferred lymph node dissection was two-field in 86%. A gastric conduit was the preferred method of reconstruction in 95%. In 2014, the preferred approach to esophagectomy was minimally invasive transthoracic in 43%, compared with 14% in 2007. In minimally invasive transthoracic esophagectomy the cervical anastomosis was favored in 54% of respondents in 2014 compared with 87% in 2007. The preferred technique of construction of the cervical anastomosis was hand-sewn in 64% and stapled in 36%, whereas the thoracic anastomosis was stapled in 77% and hand-sewn in 23%. The preferred surgical approach for Siewert type 1 tumors (5-1 cm proximal of the GEJ) was esophagectomy in 93% of respondents, whereas 6% favored gastrectomy and 3% combined a distal esophagectomy with a proximal gastrectomy. For Siewert type 2 tumors (1-2 cm from the GEJ) an extended gastrectomy was favored by 66% of respondents, followed by esophagectomy in 27% and total gastrectomy in 7%. Siewert type 3 tumors (2-5 cm distal of the GEJ) were preferably treated with gastrectomy in 90% of respondents, esophagectomy in 6%, and extended gastrectomy in 4%. The preferred curative surgical treatment of esophageal cancer is minimally invasive transthoracic esophagectomy with a two-field lymph node dissection and gastric conduit reconstruction. A strong worldwide trend toward minimally invasive surgery is observed. The preferred surgical treatment of GEJ tumors is esophagectomy for Siewert type 1 tumors and gastrectomy for Siewert type 3 tumors. The majority of surgeons favor an extended gastrectomy for Siewert type 2 tumors

Resection of liver metastases in patients with gastrointestinal stromal tumors in the imatinib era:A nationwide retrospective study

Contains fulltext : 171401.pdf (publisher's version ) (Closed access)INTRODUCTION: Liver metastases are common in patients with gastrointestinal stromal tumors (GIST). In the absence of randomized controlled clinical trials, the effectiveness of surgery as a treatment modality is unclear. This study identifies safety and outcome in a nationwide study of all patients who underwent resection of liver metastases from GIST. METHODS: Patients were included using the national registry of histo- and cytopathology (PALGA) of the Netherlands from 1999. Kaplan Meier survival analysis was used for calculating survival outcome. Univariate and multivariate regression analyses were carried out for the assessment of potential prognostic factors. RESULTS: A total of 48 patients (29 male, 19 female) with a median age of 58 (range 28-81) years were identified. Preoperative and postoperative tyrosine kinase inhibitor therapy was given to 30 (63%) and 36 (75%) patients, respectively. A minor liver resection was performed in 32 patients, 16 patients underwent major liver resection. Median follow-up was 27 (range 1-146) months. Median progression-free survival (PFS) was 28 (range 1-121) months. One-, three-, and five-year PFS was 93%, 67%, and 59% respectively. Median overall survival (OS) was 90 (range 1-146) months from surgery. The one-, three-, and five-year OS was 93%, 80%, and 76% respectively. R0 resection was the only independent significant prognostic factor for DFS and OS at multivariate analysis. CONCLUSION: Resection of liver metastases in GIST patients combined with imatinib may be associated with prolonged overall survival when a complete resection is achieved

The diagnostic performance of 18F-FDG PET/CT, CT and MRI in the treatment evaluation of ablation therapy for colorectal liver metastases : A systematic review and meta-analysis

Purpose Uncertainty exists regarding the optimal imaging modality for timely detection of disease progression (DP) after ablation therapy for colorectal liver metastases. We evaluated the diagnostic accuracy of 18F-FDG PET(/CT), CT and MRI for detection of DP following ablation therapy. Methods A systematic search was performed on May 18, 2016. The analysis included studies that reported on the diagnostic accuracy of 18F-FDG PET(/CT), CT and/or MRI for post-ablative evaluation of patients with liver metastases. Primary outcome was the diagnostic accuracy of the imaging modalities for detection of DP. Methodological quality was assessed using the QUADAS-2 tool. Pooled sensitivities and specificities were estimated using bivariate random-effects models. Results Ten studies were included in the meta-analysis, including seven comparative studies. Nine reported data on diagnostic accuracy of 18F-FDG PET(/CT), seven on CT imaging. Only two studies reported the diagnostic accuracy of MRI, hence not included in the meta-analysis. Quality assessment raised concerns about the risk of bias regarding the use of the reference standard, blinding of the index tests and the follow-up time. Pooled sensitivity was respectively 84.6% (75.0–90.6) and 53.4% (29.0–76.4) for 18F-FDG PET(/CT) and CT (P = 0.005). Pooled specificity was respectively 92.4% (86.5–95.9) and 95.7% (87.5–98.6) (P = 0.392). Conclusion 18F-FDG PET/(CT) yields a higher sensitivity for detecting DP after ablation therapy compared with CT and has a comparably high specificity. These findings indicate that the use of 18F-FDG PET(/CT) in this setting particularly allows for minimization of the false-negative rate compared with CT without compromising the low false-positive rate

Resection of hepatic and pulmonary metastasis from metastatic esophageal and gastric cancer: A nationwide study

The standard of care for gastroesophageal cancer patients with hepatic or pulmonary metastases is best supportive care or palliative chemotherapy. Occasionally, patients can be selected for curative treatment instead. This study aimed to evaluate patients who underwent a resection of hepatic or pulmonary metastasis with curative intent. The Dutch national registry for histo- and cytopathology was used to identify these patients. Data were retrieved from the individual patient files. Kaplan-Meier survival analysis was performed. Between 1991 and 2016, 32,057 patients received a gastrectomy or esophagectomy for gastroesophageal cancer in the Netherlands. Of these patients, 34 selected patients received a resection of hepatic metastasis (n = 19) or pulmonary metastasis (n = 15) in 21 different hospitals. Only 4 patients received neoadjuvant therapy before metastasectomy. The majority of patients had solitary, metachronous metastases. After metastasectomy, grade 3 (Clavien-Dindo) complications occurred in 7 patients and mortality in 1 patient. After resection of hepatic metastases, the median potential follow-up time was 54 months. Median overall survival (OS) was 28 months and the 1-, 3-, and 5- year OS was 84%, 41%, and 31%, respectively. After pulmonary metastases resection, the median potential follow-up time was 80 months. The median OS was not reached and the 1-, 3-, and 5- year OS was 67%, 53%, and 53%, respectively. In selected patients with gastroesophageal cancer with hepatic or pulmonary metastases, metastasectomy was performed with limited morbidity and mortality and offered a 5-year OS of 31-53%. Further prospective studies are required

Erratum: Resection of hepatic and pulmonary metastasis from metastatic esophageal and gastric cancer: a nationwide study (vol 25, doz034, 2019) : Resection of hepatic and pulmonary metastasis from metastatic esophageal and gastric cancer: a nationwide study

Through no fault of the authors, the following changes to the articlewere missed. These have since been corrected. The publisher apologizes for these errors. The contributors who were part of the Gastroesophageal Metastasectomy Group were mistakenly labelled as authors of the article. The author names and affiliations have since been corrected. The author name H. van Berge has been corrected to M. I. van Berge Henegouwen. The following footnote has been added to Table 1: ‘‡Both patients had a high-grade neuroendocrine neoplasm with a Ki-index of >20% or >20 mitoses per 10 high power fields, which were thus classified as euroendocrine carcinoma (40).’ The footnote numbering in this table has also been adjusted. Reference 40 has been added. The word ‘predominantly’ has been added to the second sentence of the Discussion section

Resection of hepatic and pulmonary metastasis from metastatic esophageal and gastric cancer : a nationwide study

The standard of care for gastroesophageal cancer patients with hepatic or pulmonary metastases is best supportive care or palliative chemotherapy. Occasionally, patients can be selected for curative treatment instead. This study aimed to evaluate patients who underwent a resection of hepatic or pulmonary metastasis with curative intent. The Dutch national registry for histo- and cytopathology was used to identify these patients. Data were retrieved from the individual patient files. Kaplan-Meier survival analysis was performed. Between 1991 and 2016, 32,057 patients received a gastrectomy or esophagectomy for gastroesophageal cancer in the Netherlands. Of these patients, 34 selected patients received a resection of hepatic metastasis (n = 19) or pulmonary metastasis (n = 15) in 21 different hospitals. Only 4 patients received neoadjuvant therapy before metastasectomy. The majority of patients had solitary, metachronous metastases. After metastasectomy, grade 3 (Clavien-Dindo) complications occurred in 7 patients and mortality in 1 patient. After resection of hepatic metastases, the median potential follow-up time was 54 months. Median overall survival (OS) was 28 months and the 1-, 3-, and 5- year OS was 84%, 41%, and 31%, respectively. After pulmonary metastases resection, the median potential follow-up time was 80 months. The median OS was not reached and the 1-, 3-, and 5- year OS was 67%, 53%, and 53%, respectively. In selected patients with gastroesophageal cancer with hepatic or pulmonary metastases, metastasectomy was performed with limited morbidity and mortality and offered a 5-year OS of 31-53%. Further prospective studies are required