Browsing by Author "Radaelli, Franco"

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    Combination of Mucosa-Exposure Device and Computer-Aided Detection for Adenoma Detection During Colonoscopy: A Randomized Trial
    (Elsevier, 2023-07) Spadaccini, Marco; Hassan, Cesare; Rondonotti, Emanuele; Antonelli, Giulio; Andrisani, Gianluca; Lollo, Gianluca; Auriemma, Francesco; Iacopini, Federico; Facciorusso, Antonio; Maselli, Roberta; Fugazza, Alessandro; Bambina Bergna, Irene Maria; Cereatti, Fabrizio; Mangiavillano, Benedetto; Radaelli, Franco; Di Matteo, Francesco; Gross, Seth A.; Sharma, Prateek; Mori, Yuichi; Bretthauer, Michael; Rex, Douglas K.; Repici, Alessandro; Medicine, School of Medicine
    Background & Aims Both computer-aided detection (CADe)-assisted and Endocuff-assisted colonoscopy have been found to increase adenoma detection. We investigated the performance of the combination of the 2 tools compared with CADe-assisted colonoscopy alone to detect colorectal neoplasias during colonoscopy in a multicenter randomized trial. Methods Men and women undergoing colonoscopy for colorectal cancer screening, polyp surveillance, or clincial indications at 6 centers in Italy and Switzerland were enrolled. Patients were assigned (1:1) to colonoscopy with the combinations of CADe (GI-Genius; Medtronic) and a mucosal exposure device (Endocuff Vision [ECV]; Olympus) or to CADe-assisted colonoscopy alone (control group). All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was adenoma detection rate (percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, advanced adenomas and serrated lesions detection rate, the rate of unnecessary polypectomies (polyp resection without histologically proven adenomas), and withdrawal time. Results From July 1, 2021 to May 31, 2022, there were 1316 subjects randomized and eligible for analysis; 660 to the ECV group, 656 to the control group). The adenoma detection rate was significantly higher in the ECV group (49.6%) than in the control group (44.0%) (relative risk, 1.12; 95% CI, 1.00–1.26; P = .04). Adenomas detected per colonoscopy were significantly higher in the ECV group (mean ± SD, 0.94 ± 0.54) than in the control group (0.74 ± 0.21) (incidence rate ratio, 1.26; 95% CI, 1.04–1.54; P = .02). The 2 groups did not differ in term of detection of advanced adenomas and serrated lesions. There was no significant difference between groups in mean ± SD withdrawal time (9.01 ± 2.48 seconds for the ECV group vs 8.96 ± 2.24 seconds for controls; P = .69) or proportion of subjects undergoing unnecessary polypectomies (relative risk, 0.89; 95% CI, 0.69–1.14; P = .38). Conclusions The combination of CADe and ECV during colonoscopy increases adenoma detection rate and adenomas detected per colonoscopy without increasing withdrawal time compared with CADe alone.
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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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    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.