Browsing by Author "Fugazza, Alessandro"

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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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    Prophylactic Clipping After Colorectal Endoscopic Resection Prevents Bleeding of Large, Proximal Polyps: Meta-Analysis of Randomized Trials
    (Elsevier, 2020) Spadaccini, Marco; Albéniz, Eduardo; Pohl, Heiko; Maselli, Roberta; Chandrasekar, Viveksandeep Thoguluva; Correale, Loredana; Anderloni, Andrea; Carrara, Silvia; Fugazza, Alessandro; Badalamenti, Matteo; Iwatate, Mineo; Antonelli, Giulio; Enguita-Germán, Mónica; Álvarez, Marco Antonio; Sharma, Prateek; Rex, Douglas K.; Hassan, Cesare; Repici, Alessandro; Medicine, School of Medicine
    Background & Aims The benefits of prophylactic clipping to prevent bleeding after polypectomy are unclear. We conducted an updated meta-analysis of randomized trials to assess the efficacy of clipping in preventing bleeding after polypectomy, overall and according to polyp size and location. Methods We searched the Medline/PubMed, EMBASE, and Scopus databases randomized trials that compared effects of clipping vs not clipping to prevent bleeding after polypectomy. We performed a random-effects meta-analysis to generate pooled relative risks (RRs) with 95% CIs. Multilevel random-effects meta-regression analysis was used to combine data on bleeding after polypectomy and estimate associations between rates of bleeding and polyp characteristics. Results We analyzed data from 9 trials, comprising 7197 colorectal lesions (22.5% 20 mm or larger, 49.2% with proximal location). Clipping, compared with no clipping, did not significantly reduce the overall risk of post-polypectomy bleeding (2.2% with clipping vs 3.3% with no clipping; RR, 0.69; 95% CI, 0.45–1.08; P=.072). Clipping significantly reduced risk of bleeding after removal of polyps that were 20 mm or larger (4.3% had bleeding after clipping vs 7.6% had bleeding with no clipping; RR, 0.51; 95% CI, 0.33–0.78; P=.020) or that were in a proximal location (3.0% had bleeding after clipping vs 6.2% had bleeding with no clipping; RR, 0.53; 95% CI, 0.35–0.81; P<.001). In multilevel meta-regression analysis that adjusted for polyp size and location, prophylactic clipping was significantly associated with reduced risk of bleeding after removal of large proximal polyps (RR, 0.37; 95% CI, 0.22–0.61; P=.021) but not small proximal lesions (RR, 0.88; 95% CI, 0.48–1.62; P=0.581). Conclusions In a meta-analysis of randomized trials, we found that routine use of prophylactic clipping does not reduce risk of post-polypectomy bleeding, overall. However, clipping appeared to reduce bleeding after removal of large (more than 20 mm), proximal lesions.
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    Variability in Adenoma Detection Rate in Control Groups of Randomized Colonoscopy Trials
    (Elsevier, 2022) Hassan, Cesare; Piovani, Daniele; Spadaccini, Marco; Parigi, Tommaso; Khalaf, Kareem; Facciorusso, Antonio; Fugazza, Alessandro; Rösch, Thomas; Bretthauer, Michael; Mori, Yuichi; Sharma, Prateek; Rex, Douglas K.; Bonovas, Stefanos; Repici, Alessandro; Medicine, School of Medicine
    Background: Adenoma Detection Rate (ADR) is still the main surrogate outcome parameter of screening colonoscopy, but most of the studies included mixed indications and basic ADR is quite variable. We therefore looked at the control groups in randomized ADR trials using advanced imaging or mechanical methods to find out whether indications or other factors influence ADR levels. Methods: Patients in the control groups of randomized studies on ADR increase using various methods were collected based on a systematic review; this control group had to use high-definition (HD) white-light endoscopy performed between 2008 and 2021. Random-effects meta-analysis was used to pool ADR in control groups and its 95% confidence interval [CI] according to the following parameters: clinical (indication and demographic), study setting (tandem/parallel, N° centres, sample size), and technical (type of intervention, withdrawal time). Inter-study heterogeneity was reported with I-squared statistic. Multivariable mixed-effects meta-regression was performed for potentially relevant variables. Findings: 25,304 patients from 80 studies in the respective control groups were included. ADR in control arms varied between 8.2% and 68.1% with a high degree of heterogeneity (I2 = 95.1%; random-effect pooled value: 37.5% [34.6‒40.5]). There was no difference in ADR levels between primary colonoscopy screening (12 RCTs, 15%), and mixed indications including screening/surveillance and diagnostic colonoscopy; however, FIT as an indication for colonoscopy was an independent predictor of ADR (OR: 1.6 [1.1‒2.4]). Other well known parameters were confirmed by our analysis such as age (OR: 1.038 [1.004‒1.074]) and sex (male sex: OR: 1.02 [1.01‒1.03) as well withdrawal time (OR: 1.1 [1.0‒1.1). The type of intervention (imaging vs. mechanical) had no influence, but methodological factors did: more recent year of publication and smaller sample size were associated with higher ADR. Interpretation: A high level of variability was found in the level of ADR in the controls of RCTs. With regards to indications, only FIT-based colonoscopy studies influenced basic ADR, primary colonoscopy screening appeared to be similar to other indications. Standardization for variables related to clinical, methodological, and technical parameters is required to achieve generalizability and reproducibility.