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Browsing by Author "Ricciardiello, Luigi"
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Item Delphi Initiative for Early-Onset Colorectal Cancer (DIRECt) International Management Guidelines(Elsevier, 2023) Cavestro, Giulia Martina; Mannucci, Alessandro; Balaguer, Francesc; Hampel, Heather; Kupfer, Sonia S.; Repici, Alessandro; Sartore-Bianchi, Andrea; Seppälä, Toni T.; Valentini, Vincenzo; Boland, Clement Richard; Brand, Randall E.; Buffart, Tineke E.; Burke, Carol A.; Caccialanza, Riccardo; Cannizzaro, Renato; Cascinu, Stefano; Cercek, Andrea; Crosbie, Emma J.; Danese, Silvio; Dekker, Evelien; Daca-Alvarez, Maria; Deni, Francesco; Dominguez-Valentin, Mev; Eng, Cathy; Goel, Ajay; Guillem, Josè G.; Houwen, Britt B. S. L.; Kahi, Charles; Kalady, Matthew F.; Kastrinos, Fay; Kühn, Florian; Laghi, Luigi; Latchford, Andrew; Liska, David; Lynch, Patrick; Malesci, Alberto; Mauri, Gianluca; Meldolesi, Elisa; Møller, Pål; Monahan, Kevin J.; Möslein, Gabriela; Murphy, Caitlin C.; Nass, Karlijn; Ng, Kimmie; Oliani, Cristina; Papaleo, Enrico; Patel, Swati G.; Puzzono, Marta; Remo, Andrea; Ricciardiello, Luigi; Ripamonti, Carla Ida; Siena, Salvatore; Singh, Satish K.; Stadler, Zsofia K.; Stanich, Peter P.; Syngal, Sapna; Turi, Stefano; Urso, Emanuele Damiano; Valle, Laura; Vanni, Valeria Stella; Vilar, Eduardo; Vitellaro, Marco; You, Yi-Qian Nancy; Yurgelun, Matthew B.; Zuppardo, Raffaella Alessia; Stoffel, Elena M.; Associazione Italiana Familiarità Ereditarietà Tumori; Collaborative Group of the Americas on Inherited Gastrointestinal Cancer; European Hereditary Tumour Group; International Society for Gastrointestinal Hereditary Tumours; Medicine, School of MedicineBackground & aims: Patients with early-onset colorectal cancer (eoCRC) are managed according to guidelines that are not age-specific. A multidisciplinary international group (DIRECt), composed of 69 experts, was convened to develop the first evidence-based consensus recommendations for eoCRC. Methods: After reviewing the published literature, a Delphi methodology was used to draft and respond to clinically relevant questions. Each statement underwent 3 rounds of voting and reached a consensus level of agreement of ≥80%. Results: The DIRECt group produced 31 statements in 7 areas of interest: diagnosis, risk factors, genetics, pathology-oncology, endoscopy, therapy, and supportive care. There was strong consensus that all individuals younger than 50 should undergo CRC risk stratification and prompt symptom assessment. All newly diagnosed eoCRC patients should receive germline genetic testing, ideally before surgery. On the basis of current evidence, endoscopic, surgical, and oncologic treatment of eoCRC should not differ from later-onset CRC, except for individuals with pathogenic or likely pathogenic germline variants. The evidence on chemotherapy is not sufficient to recommend changes to established therapeutic protocols. Fertility preservation and sexual health are important to address in eoCRC survivors. The DIRECt group highlighted areas with knowledge gaps that should be prioritized in future research efforts, including age at first screening for the general population, use of fecal immunochemical tests, chemotherapy, endoscopic therapy, and post-treatment surveillance for eoCRC patients. Conclusions: The DIRECt group produced the first consensus recommendations on eoCRC. All statements should be considered together with the accompanying comments and literature reviews. We highlighted areas where research should be prioritized. These guidelines represent a useful tool for clinicians caring for patients with eoCRC.Item Diagnostic Yield and Miss Rate of EndoRings in an Organized Colorectal Cancer Screening Program: the SMART (Study Methodology for ADR-Related Technology) Trial(Elsevier, 2018) Hassan, Cesare; Senore, Carlo; Manes, Gianpiero; Fuccio, Lorenzo; Iacopini, Federico; Ricciardiello, Luigi; Anderloni, Andrea; Frazzoni, Leonardo; Ballanti, Riccardo; de Nucci, Germana; Colussi, Dora; Radaelli, Davide; Lorenzetti, Roberto; Devani, Massimo; Arena, Ilaria; Grossi, Cristina; Andrei, Fabio; Balestrazzi, Eleonora; Sharma, Prateek; Rex, Douglas K.; Repici, Alessandro; Medicine, School of MedicineBackground and aims The add-on EndoRings has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty on their correspondence. Aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia. Methods Consecutive subjects undergoing colonoscopy after a positive fecal immunochemical test (FIT) within organized screening program in 7 Italian centers, were randomized between a parallel (EndoRings or Standard) or a crossover (EndoRings/Standard or Standard/EndoRings) methodology. Outcomes measures were the detection rates of (advanced) adenomas (A-)ADR in the parallel arms and miss rate of adenomas in the crossover arms. Results Of 958 eligible subjects, 927 (317 EndoRings; 317 Standard; 142 EndoRings/Standard; 151 Standard/Endorings) were included in the final analysis. In the parallel arms (mean ADR: 51.3%; mean AADR: 25.4%), no difference between Standard and EndoRings was found for both ADR (RR, 1.10; 95% CI, 0.95-1.28) and A-ADR (RR, 1.16; 95% CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings: 1.9±1.3 and 1.0±1.2; Standard 2.1±1.5 and 1.0±1.2; p=NS for both comparisons). In the crossover arms, no difference in miss rate for adenomas between EndoRings and Standard was found at per-polyp (RR, 1.43; 95% CI, 0.97-2.10), as well as at per-patient analysis (24% vs 26%; p=0.76). Conclusions No statistically significant difference in diagnostic yield and miss rate between EndoRings and Standard colonoscopy was detected in FIT+ patients. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship.