Browsing by Author "Frazzoni, Leonardo"

Now showing 1 - 4 of 4
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    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 Medicine
    Background 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.
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    Efficacy and Tolerability of High- vs Low-Volume Split-Dose Bowel Cleansing Regimens for Colonoscopy: A Systematic Review and Meta-analysis
    (Elsevier, 2019) Spadaccini, Marco; Frazzoni, Leonardo; Vanella, Giuseppe; East, James; Radaelli, Franco; Spada, Cristiano; Fuccio, Lorenzo; Benamouzig, Robert; Bisschops, Raf; Bretthauer, Michael; Dekker, Evelien; Dinis-Ribeiro, Mario; Ferlitsch, Monika; Gralnek, Ian; Jover, Rodrigo; Kaminski, Michael F.; Pellisé, Maria; Triantafyllou, Konstantinos; Van Hooft, Jeanin E.; Dumonceau, Jean-Marc; Marmo, Clelia; Alfieri, Sergio; Chandrasekar, Viveksandeep Thoguluva; Sharma, Prateek; Rex, Doug K.; Repici, Alessandro; Hassan, Cesare; Medicine, School of Medicine
    Background & Aims Efficacy of bowel preparation is an important determinant of outcomes of colonoscopy. It is not clear whether approved low-volume polyethylene glycol (PEG) and non-PEG regimens are as effective as high-volume PEG regimens when taken in a split dose. Methods In a systematic review of multiple electronic databases through January 31, 2019 with a registered protocol (PROSPERO: CRD42019128067), we identified randomized controlled trials that compared low- vs high-volume bowel cleansing regimens, administered in a split dose, for colonoscopy. The primary efficacy outcome was rate of adequate bowel cleansing, and the secondary efficacy outcome was adenoma detection rate. Primary tolerability outcomes were compliance, tolerability, and willingness to repeat. We calculated relative risk (RR) and 95% CI values and assessed heterogeneity among studies by using the I2 statistic. The overall quality of evidence was assessed using the GRADE framework. Results In an analysis of data from 17 randomized controlled trials, comprising 7528 patients, we found no significant differences in adequacy of bowel cleansing between the low- vs high-volume split-dose regimens (86.1% vs 87.4%; RR, 1.00; 95% CI, 0.98–1.02) and there was minimal heterogeneity (I2 = 17%). There was no significant difference in adenoma detection rate (RR, 0.96; 95% CI, 0.87–1.08) among 4 randomized controlled trials. Compared with high-volume, split-dose regimens, low-volume split-dose regimens had higher odds for compliance or completion (RR, 1.06; 95% CI, 1.02–1.10), tolerability (RR, 1.39; 95% CI, 1.12–1.74), and willingness to repeat bowel preparation (RR, 1.41; 95% CI, 1.20–1.66). The overall quality of evidence was moderate. Conclusions Based on a systematic review of 17 randomized controlled trials, low-volume, split-dose regimens appear to be as effective as high-volume, split-dose regimens in bowel cleansing and are better tolerated, with superior compliance.
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    Low diagnostic yield of transduodenal endoscopic ultrasound-guided fine needle biopsy using the 19-gauge Flex needle: A large multicenter prospective study
    (Medknow Publications, 2017) Attili, Fabia; Fabbri, Carlo; Yasuda, Ichiro; Fuccio, Lorenzo; Palazzo, Laurent; Tarantino, Ilaria; Dewitt, John; Frazzoni, Leonardo; Rimbaş, Mihai; Larghi, Alberto; Medicine, School of Medicine
    Background and Objectives: Previous limited experiences have reported the 19-gauge flexible needle to be highly effective in performing endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for transduodenal lesions. We designed a large multicenter prospective study with the aim at evaluating the performance of this newly developed needle. Patients and Methods: Consecutive patients with solid lesions who needed to undergo EUS sampling from the duodenum were enrolled in 6 tertiary care referral centers. Puncture of the lesion was performed with the 19-gauge flexible needle (Expect™ and Slimline Expect™ 19 Flex). The feasibility, procurement yield, and diagnostic accuracy were evaluated. Results: Totally, 246 patients (144 males, mean age 65.1 ± 12.7 years) with solid lesions (203 cases) or enlarged lymph nodes (43 cases) were enrolled, with a mean size of 32.6 ± 12.2 mm. The procedure was technically feasible in 228 patients, with an overall procurement yield of 76.8%. Two centers had suboptimal procurement yields (66.7% and 64.2%). Major complications occurred in six cases: two of bleeding, two of mild acute pancreatitis, one perforation requiring surgery, and one duodenal hematoma. Considering malignant versus nonmalignant disease, the sensitivity, specificity, positive/negative likelihood ratios, and diagnostic accuracy were 70.7% (95% confidence interval [CI]: 64.3–76.6), 100% (95% CI: 79.6–100), 35.3 (95% CI: 2.3–549.8)/0.3 (95% CI: 0.2–0.4), and 73.6% (95% CI: 67.6–79). On multivariate analysis, the only determinant of successful EUS-FNB was the center in which the procedure was performed. Conclusions: Our results suggest that the use of the 19-gauge flexible needle cannot be widely advocated and its implementation should receive local validation after careful evaluation of both the technical success rates and diagnostic yield.
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    New and Recurrent Colorectal Cancers After Resection: a Systematic Review and Meta-analysis of Endoscopic Surveillance Studies
    (Elsevier, 2019) Fuccio, Lorenzo; Rex, Douglas K.; Ponchon, Thierry; Frazzoni, Leonardo; Dinis-Ribeiro, Mário; Bhandari, Pradeep; Dekker, Evelien; Pellisè, Maria; Correale, Loredana; van Hooft, Jeanin; Jover, Rodrigo; Libanio, Diogo; Radaelli, Franco; Alfieri, Sergio; Bazzoli, Franco; Senore, Carlo; Regula, Jaroslaw; Seufferlein, Thomas; Rösch, Thomas; Sharma, Prateek; Repici, Alessandro; Hassan, Cesare; Medicine, School of Medicine
    Background & Aims Outcomes of endoscopic surveillance following surgery for colorectal cancer (CRC) vary with the incidence and timing of CRC detection, at anastomoses or non- anastomoses in the colorectum. We performed a systematic review and meta-analysis to evaluate the incidence of CRCs identified during surveillance colonoscopies of patients who have already undergone surgery for this cancer. Methods We searched PubMed, EMBASE, SCOPUS, and the Cochrane Central Register of Clinical Trials through January 1, 2018 to identify studies investigating rates of CRCs at anastomoses or other locations in the colorectum after curative surgery for primary CRC. We collected data from published randomized controlled, prospective, and retrospective cohort studies. Data were analyzed by multivariate meta-analytic models. Results From 2373 citations, we selected 27 studies with data on 15,803 index CRCs for analysis (89% of patients with stage 1–3 CRC). Overall, 296 CRCs at non-anastomotic locations were reported over time periods of more than 16 years (cumulative incidence, 2.2% of CRCs; 95% CI, 1.8%–2.9%). The risk of CRC at a non-anastomotic location was significantly reduced more than 36 months after resection compared with before this timepoint (odds ratio for non-anastomotic CRCs at 36–48 months vs 6–12 months after surgery, 0.61; 95% CI, 0.37–0.98; P=.031); 53.7% of all non-anastomotic CRCs were detected within 36 months of surgery. One hundred fifty-eight CRCs were detected at anastomoses (cumulative incidence of 2.7%; 95% CI, 1.9%–3.9%). The risk of CRCs at anastomoses was significantly lower 24 months after resection than before (odds ratio for CRCs at anastomoses at 25–36 months after surgery vs 6–12 months, 0.56; 95% CI, 0.32–0.98; P=.036); 90.8% of all CRCs at anastomoses were detected within 36 months of surgery. Conclusions After surgery for CRC, the highest risk of CRCs at anastomoses and at other locations in the colorectum is highest during 36 months after surgery—risk decreases thereafter. Patients who have undergone CRC resection should be evaluated by colonoscopy more closely during this time period. Longer intervals may be considered thereafter.