Rectal Sparing Approach After Preoperative Radio and/or Chemotherapy in Patients With Rectal Cancer
The proposed study is an observational, prospective, multicenter study of patients undergoing neoadjuvant therapy for medium-low rectal cancer. Recently the investigators have published the findings of a multicenter Italian phase II study showing that the rate of local recurrence, with a 3 year follow-up, is less than 5% in patients with baseline T2-3 mid-low rectal cancer who, after preoperative chemoradiotherapy (pCRT), showed a major clinical response and underwent a transanal local excision. Based on these results, an organ-sparing approach for patients showing a major clinical response is feasible without reducing the good results obtained with the standard treatment. While a phase III trial is the best way to compare the standard treatment with the organ-sparing approach (local excision or wait-and-see) it is impracticable and likely unethical. An observational study is therefore one of the best way to evaluate the impact that an organ-sparing approach may have on oncological outcomes, quality of life, and bowel function for patients with rectal cancer who, after a pCRT, show a clinical major/complete response. This phase II trial is designed to test the hypothesis that conservative treatments, in patients with low-mid rectal cancer who undergo a major or complete clinical response after neoadjuvant treatment, will be safe and effective compared to standard surgery. The investigators will compare rectum-sparing approaches to standard surgery, firstly in terms of rate of organ preservation at 2 years. Additionally they will compare survival outcomes (DFS, OS), stoma rates, clinical and tumor factors related to pathological complete response, correlation between major and complete clinical response. To add value, the investigators will measure QoL in patients treated with rectum-sparing approaches in comparison to patients treated with standard surgery (TME or abdomino-perineal amputation). Rectum-sparing approach can be considered clinically acceptable if percentage of conservation of the rectum at two years is not less than 50%. The collected data on 164 patients who underwent "rectum-sparing" allow to test the hypothesis that the rectum is preserved in 60% of patients with 80% power (exact binomial test for proportions, alpha = 5 %, 1 tail) and the study will be considered positive if it obtains a frequency of conservation of the rectum of not less than 87 cases. The analysis results will be reported in accordance with STROBE guidelines (von Elm et al., 2008). For all analyzes, continuous variables are described using the mean and standard deviation of position and appropriate measures when appropriate. Categorical variables will be described using the contingency tables.
A Phase II Single-arm Study for the Treatment After Recurrence of Advanced Melanoma Patients Harboring the V600BRAF Mutation and Pretreated With Vemurafenib, With the Association of Vemurafenib Plus Fotemustine.
The purpose of this study is to evaluate the activity of Vemurafenib in combination with Fotemustine in Patients with unresectable Stage IV melanoma harboring V600 BRAF mutation who recurred while in treatment with Vemurafenib. In addition the feasibility and safety profile of prolonging treatment of this drugs combination will be assessed.
Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion
A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35 (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply overweight patients. A new prospective study was then planned with the aim to gain insight in the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1 month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the fifth year.
Corrigendum to “Nivolumab plus ipilimumab in melanoma patients with asymptomatic brain metastases: 7-year outcomes and quality of life from the multicenter phase III NIBIT-M2 trial” [Eur J Cancer 199 (2024) 113531]
作者: Maio, Michele ; Guida, Michele ; Del Vecchio, Michele ; Ferrucci, Pier Francesco ; Marchetti, Paolo ; Di Giacomo, Anna Maria ; Amato, Giovanni ; Quaglino, Pietro ; Camerini, Roberto ; Simonetti, Elena ; Mandalà, Mario ; Chiarion-Sileni, Vanna ; Santangelo, Federica ; Valente, Monica ; Covre, Alessia ; Giannarelli, Diana ; Calabrò, Luana ; Guidoboni, Massimo
2024-04-01·ESGE Days 2024
Cold snare polypectomy in the management of duodenal adenoma in familial adenomatous polyposis
作者: Rausa, E. ; Cantù, P. ; Cavalcoli, F. ; Magarotto, A. ; Borsotti, E. ; Lauricella, S. ; Benedicenti, F. ; Rosa, R. ; Mancini, A. ; Vitellaro, M.
2024-04-01·ESGE Days 2024
Incidence and Characteristics of Endoscopic Gastric Polyps in Patients with Autoimmune Atrophic Gastritis: A Multicentric Retrospective Study
作者: Massironi, S. ; Sciola, V. ; De Rossi, G. ; Annibale, B. ; Vecchi, M. ; Lenti, M. V. ; Dottori, L. ; Miceli, E. ; Cantù, P. ; Zilli, A. ; Lahner, E. ; Gallo, C. ; Cavalcoli, F. ; Invernizzi, P. ; Di Sabatino, A. ; Danese, S.