Moonen A.,Catholic University of Leuven |
Annese V.,AOU Careggi |
Belmans A.,Interuniversity Center for Biostatistics and Statistical Bioinformatics |
Varannes S.B.D.,University of Nantes |
And 9 more authors.
Gut | Year: 2016
Objective: Achalasia is a chronic motility disorder of the oesophagus for which laparoscopic Heller myotomy (LHM) and endoscopic pneumodilation (PD) are the most commonly used treatments. However, prospective data comparing their long-term efficacy is lacking. Design:201 newly diagnosed patients with Achalasia were randomly assigned to PD (n=96) or LHM (n=105). Before randomisation, symptoms were assessed using the Eckardt score, functional test were performed and quality of life was assessed. The primary outcome was therapeutic success (presence of Eckardt score =3) at the yearly follow-up assessment. The secondary outcomes included the need for re-treatment, lower oesophageal sphincter pressure, oesophageal emptying and the rate of complications. Results: In the full analysis set, there was no significant difference in success rate between the two treatments with 84% and 82% success after 5 years for LHM and PD, respectively (p=0.92, log-rank test). Similar results were obtained in the per-protocol analysis (5-year success rates: 82% for LHM vs 91% for PD, p=0.08, log-rank test). After 5 years, no differences in secondary outcome parameter were observed. Redilation was performed in 24 (25%) of PD patients. Five oesophageal perforations occurred during PD (5%) while 12 mucosal tears (11%) occurred during LHM. Conclusions: After at least 5 years of follow-up, PD and LHM have a comparable success rate with no differences in oesophageal function and emptying. However, 25% of PD patients require redilation during follow-up. Based on these data, we conclude that either treatment can be proposed as initial treatment for Achalasia. Trial registration numbers Netherlands trial register (NTR37) and Current Controlled Trials registry (ISRCTN56304564).
Clemente S.,Instituto Of Ricovero E Cura A Carattere Scientifico |
Nigro R.,Azienda Sanitaria Locale Rieti |
Oliviero C.,Instituto Of Ricovero E Cura A Carattere Scientifico |
Marchioni C.,Azienda Sanitaria Locale Rieti |
And 9 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2015
The increasing use of moderate (<35 fractions) and extreme (<5 fractions) hypofractionated radiation therapy in prostate cancer is yielding favorable results, both in terms of maintained biochemical response and toxicity. Several hypofractionation (HF) schemes for the treatment of prostate cancer are available, although there is considerable variability in the techniques used to manage intra-/interfraction motion and deliver radiation doses. We performed a review of the published studies on HF regimens as a topic of interest for the Stereotactic Ablative Radiotherapy working group, which is part of the Italian Association of Medical Physics. Aspects of organ motion management (imaging for contouring, target volume definition, and rectum/bladder preparation) and treatment delivery (prostate localization, image guided radiation therapy strategy and frequency) were evaluated and categorized to assess outcome relative to disease control and toxicity. Despite the heterogeneity of the data, some interesting trends that emerged from the review might be useful in identifying an optimum HF strategy. © 2015 Elsevier Inc.
PubMed | Ospedale Sacro Cuore Don Calabria, Humanitas Clinical and Research Hospital, University of Naples Federico II, University of Milan and 2 more.
Type: Journal Article | Journal: Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB) | Year: 2016
Emerging data are showing the safety and the efficacy of Stereotactic Body Radiation Therapy (SBRT) in prostate cancer management. In this context, the medical physicists are regularly involved to review the appropriateness of the adopted technology and to proactively study new solutions. From the physics point of view there are two major challenges in prostate SBRT: (1) mitigation of geometrical uncertainty and (2) generation of highly conformal dose distributions that maximally spare the OARs. Geometrical uncertainties have to be limited as much as possible in order to avoid the use of large PTV margins. Furthermore, advanced planning and delivery techniques are needed to generate maximally conformal dose distributions. In this non-systematic review the technology and the physics aspects of SBRT for prostate cancer were analyzed. In details, the aims were: (i) to describe the rationale of reducing the number of fractions (i.e. increasing the dose per fraction), (ii) to analyze the features to be accounted for performing an extreme hypo-fractionation scheme (>6-7Gy), and (iii) to describe technological solutions for treating in a safe way. The analysis of outcomes, toxicities, and other clinical aspects are not object of the present evaluation.
Fumagalli U.,Humanitas Clinical and Research Hospital |
Rosati R.,University of Milan |
De Pascale S.,Humanitas Clinical and Research Hospital |
Porta M.,Humanitas Clinical and Research Hospital |
And 3 more authors.
Journal of Gastrointestinal Surgery | Year: 2016
Aim: Surgical myotomy of the lower esophageal sphincter has a 5-year success rate of approximately 91 %. Peroral endoscopic myotomy can provide similar results for controlling dysphagia. Some patients experience either persistent or recurrent dysphagia after myotomy. We present here a retrospective analysis of our experience with redo myotomy for recurrent dysphagia in patients with achalasia. Methods: From March 1996 to February 2015, 234 myotomies for primary or recurrent achalasia were performed in our center. Fifteen patients (6.4 %) had had a previous myotomy and were undergoing surgical redo myotomy (n = 9) or endoscopic redo myotomy (n = 6) for recurrent symptoms. Results: Patients presented at a median of 10.4 months after previous myotomy. Median preoperative Eckardt score was 6. Among the nine patients undergoing surgical myotomy, three esophageal perforations occurred intraoperatively (all repaired immediately). Surgery lasted 111 and 62 min on average (median) in the surgical and peroral endoscopic myotomy (POEM) groups, respectively. No postoperative complications occurred in either group. Median postoperative stay was 3 and 2.5 days in the surgical and POEM groups, respectively. In the surgical group, Eckardt score was <3 for seven out of nine patients after a mean follow-up of 19 months; it was <3 for all six patients in the POEM group after a mean follow-up of 5 months. Conclusions: A redo myotomy should be considered in patients who underwent myotomy for achalasia and presenting with recurrent dysphagia. Preliminary results using POEM indicate that the technique can be safely used in patients who have undergone previous surgical myotomy. © 2015, The Society for Surgery of the Alimentary Tract.
Danese S.,Humanitas Clinical and Research Hospital |
Siegel C.A.,Dartmouth Hitchcock Medical Center |
Peyrin-Biroulet L.,University of Lorraine
Alimentary Pharmacology and Therapeutics | Year: 2014
Background 5-Aminosalicylates (5-ASA) are first-line treatment for mild-moderately active ulcerative colitis (UC). When 5-ASAs fail, systemic corticosteroids have been the standard next step. Due to the significant side effect profile of systemic corticosteroids, alternative options in the treatment algorithm after 5-ASA failures are needed. Budesonide-Multi-Matrix System (MMX) is a novel oral formulation of budesonide that uses colonic release MMX technology to extend release of the drug to the colon. Now that budesonide-MMX has been approved for use in some countries, and pending in others we need to understand its position in the treatment algorithm for UC. Aim To review the available literature for budesonide-MMX and incorporate it into the treatment algorithm for mild-moderate UC. Methods The available efficacy and safety literature regarding budesonide-MMX was reviewed, and compared to 5-ASAs and systemic corticosteroids. Results In two large studies referred to as CORE (Colonic Release Budesonide trial), budesonide-MMX 9 mg daily was significantly more effective in achieving a combined end point of clinical and endoscopic remission than placebo in patients with mild-moderately active UC. Safety data are reassuring, with no clinically relevant differences between budesonide-MMX and placebo, including steroid-related side effects. Conclusions Budesonide-MMX 9 mg daily is an effective and safe treatment for induction in patients with mild-moderately active UC. At the current time, it should be considered in patients after 5-ASA failure and before systemic corticosteroids. Data are still needed to understand its role and dose beyond 8 weeks, and if it should be considered first line before 5-ASAs. © 2014 John Wiley & Sons Ltd.
Bressenot A.,University of Lorraine |
Salleron J.,Institute Of Cancerologie Of Lorraine |
Bastien C.,University of Lorraine |
Danese S.,Humanitas Clinical and Research Hospital |
And 2 more authors.
Gut | Year: 2015
Background: Assessment of disease activity in UC is important for designing an optimal therapeutic strategy. No single histology score is considered optimum. The aim of this study was to compare intraobserver reproducibility and the interobserver agreement of available histological UC activity indexes. Methods: One hundred and two biopsy specimens (collected between 2003 and 2014) were scored blindly by three pathologists by determining Geboes, Riley, Gramlich and Gupta indexes and global visual evaluation (GVE). Intraobserver reproducibility and interobserver agreements for index and items of index were studied by intraclass correlation coefficient for quantitative parameter and by ê values and Krippendorff index for qualitative parameters. Relationship between indexes was studied by computation of Pearson's and Spearman's correlation coefficients. Results: Geboes, Riley, Gramlich and Gupta indexes and GVE showed good intraobserver reproducibility and a good interobserver agreement. Histological items that showed the best interobserver agreement were 'erosion/ulceration or surface epithelial integrity' and 'acute inflammatory cells infiltrate/neutrophils in lamina propria'. The five scores were strongly correlated. Conclusions: Correlation between indexes is strong. Intraobserver reproducibility and interobserver agreement for all indexes is very good. Histological items that showed the best interobserver agreement are 'erosion/ulceration' and 'acute inflammatory cells infiltrate/neutrophils in lamina propria'.
Lopci E.,Humanitas Clinical and Research Hospital
Clinical Nuclear Medicine | Year: 2016
ABSTRACT: We report the case of a 55-year-old woman with cerebral proliferative angiopathy (CPA). Her medical history included brain surgery for small vascular lesions and suspicion of cerebral malignancy. C methionine PET (C-METH PET) demonstrated a diffusely increased uptake on the right hemisphere. Contrast-enhanced MRI documented a massive lesion with a diffuse “nidus” appearance, involving the right cerebral hemisphere (sparing the inferior frontal gyrus and the anterior frontal lobe), the brainstem, and the middle cerebellar peduncle. Pathology confirmed the diagnosis of CPA and, after radiation treatment, the patient presented with clinical and radiological response. Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
Siesto G.,Humanitas Clinical and Research Hospital |
Romano F.,Humanitas Clinical and Research Hospital |
Fiamengo B.,Humanitas Clinical and Research Hospital |
Vitobello D.,Humanitas Clinical and Research Hospital
Journal of Minimally Invasive Gynecology | Year: 2016
Study Objective: Sentinel lymph node (SLN) mapping has emerged as the new frontier for the surgical staging of apparently early-stage cervical and endometrial cancer. Different colorimetric and radioactive tracers, alone and in combination, have been proposed with encouraging results. Fluorometric mapping using indocyanine green (ICG) appears to be a suitable and attractive alternative to provide reliable staging [1-4]. Design: In this video, we present the technique of SLN mapping in 2 cases (1 endometrial and 1 cervical cancer, respectively) using ICG and the near-infrared technology provided by the newest Da Vinci Xi robotic system (Intuitive Surgical Inc., Sunnyvale, CA). Together we report the results of our preliminary experience on the first 20 cases performed. The new robotic Da Vinci Xi system was available at our institution since May 2015. Intervention: Upon institutional review board/ethical committee approval, all consecutive patients with early-stage endometrial and cervical cancer who were judged suitable for robotic surgery have been enrolled for SLN mapping with ICG. We adopted the Memorial Sloan Kettering Cancer Center SLN algorithm; the tracer was delivered into the cervix in all cases. Four milliliters (1.25 mg/mL) of ICG was injected divided into the 3- and 9-o'clock positions of the cervix alone, with 1 mL deep into the stroma and 1 mL submucosally at the skin incision. Sentinel lymph nodes were examined with a protocol including both ultrastaging with immunohistochemistry  and 1-step nucleic acid amplification assay [5,6] under a parallel protocol of study. During the study period, 20 cases were managed; 14 and 6 patients had endometrial and cervical cancer, respectively. SLN was detected in all cases (20/20, 100%). Bilateral SLNs were detected in 17 of 20 (85.0%) cases. Based on preoperative and intraoperative findings, 13 (65.0%) patients received systematic pelvic lymphadenectomy after SLN mapping. Three (15.0%) patients had microscopic nodal metastases on SLN. No patients had positive regional nodes other than SLN. No perioperative complications were recorded. Conclusion: SLN mapping has been acknowledged by the National Comprehensive Cancer Network guidelines as a viable option for the management of selected uterine malignancies [7,8]. Currently, the near-infrared technology built in the Da Vinci Xi system provides an enhanced real-time imaging system that improves the advantages given by ICG. Together with our experience, these conditions indicate that SLN mapping is an effective and safe procedure with high overall detection and low false-negative rates. © 2016 AAGL.
PubMed | Humanitas Clinical and Research Hospital
Type: Journal Article | Journal: Updates in surgery | Year: 2016
This study aims to report the hypotensive episodes (HEs) during esophagectomy and their influence on the occurrence of anastomotic leak. Eighty-four patients underwent esophagectomy with gastric pull-up. Pre-, intra-, and post-operative data were prospectively collected. HEs were defined by systolic pressure decreasing more than 30% of the basal value for more than 5min. Nineteen patients had intra-operative HEs (22.6%). HEs were significantly more frequent in patients undergoing prone esophagectomy (P=0.001) and those with an epidural catheter (EC) (P=0.04) used during surgery. Among them, 15 were treated with vasopressors. There were six severe post-operative anastomotic leaks, which required surgery; leaks were significantly more common in patients with intra-operative HEs (21 vs 3.1%; P=0.02), especially those treated with vasopressive agents (20 vs 0%; P=0.008). Intra-operative use of EC can, in certain conditions, significantly influence gastric blood flow due to HEs. A higher incidence of severe leak occurred in patients experiencing intra-operative HEs. Several factors can lead to intra-operative HEs, and the perioperative use of an EC should be carefully evaluated.
PubMed | Humanitas Clinical and Research Hospital
Type: Journal Article | Journal: Tumori | Year: 2016
We reviewed our experience of the multidisciplinary collaboration between ophthalmologists, head and neck surgeons, neurosurgeons, radiologists and oncologists in the management of extensive tumors treated by orbital exenteration at the Humanitas Research Institute, Milan, Italy, over the past 10 years.This is a retrospective cohort study of all patients who underwent orbital exenteration between March 2005 and August 2014 at the Humanitas Research Institute. The 10-year cohort of exenterated patients was identified through operating room notes using the clinical code set of the International Classification of Diseases, 10th revision (ICD-10).A total of 26 patients were identified, including 19 (73.1%) males. The median age was 65.5 years (range 37-87). Eighteen (69.2%) patients had major skin cancers extending to the orbit. Patients were divided into 2 cohorts: cohort 1 comprising patients with sinus or craniofacial cancers requiring orbital exenteration, and cohort 2 comprising patients with advanced periorbital skin cancers. The two cohorts were well matched for sex, age at surgery, degree of invasion, extension of surgical removal, necessity of adjuvant radiotherapy, reconstruction processes, and rehabilitation.In our experience patients never died of the primary lesion but because of the occurrence of other problems. So we encourage local surgical radicality.