8 results on '"F Radaelli"'
Search Results
2. Artificial intelligence and colonoscopy experience: lessons from two randomised trials.
- Author
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Repici A, Spadaccini M, Antonelli G, Correale L, Maselli R, Galtieri PA, Pellegatta G, Capogreco A, Milluzzo SM, Lollo G, Di Paolo D, Badalamenti M, Ferrara E, Fugazza A, Carrara S, Anderloni A, Rondonotti E, Amato A, De Gottardi A, Spada C, Radaelli F, Savevski V, Wallace MB, Sharma P, Rösch T, and Hassan C
- Subjects
- Adult, Aged, Aged, 80 and over, Artificial Intelligence, Colonoscopy, Early Detection of Cancer, Female, Humans, Male, Mass Screening, Middle Aged, Adenoma diagnosis, Adenoma pathology, Colonic Polyps diagnosis, Colonic Polyps pathology, Colorectal Neoplasms diagnosis, Colorectal Neoplasms pathology, Polyps
- Abstract
Background and Aims: Artificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1)., Methods: In this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (<2000 colonoscopies) performed screening/surveillance/diagnostic colonoscopies in consecutive 40-80 year-old subjects using high-definition colonoscopy with or without a real-time deep-learning computer-aided detection (CADe) (GI Genius, Medtronic). The primary outcome was ADR in both groups with histology of resected lesions as reference. In a post-hoc analysis, data from this randomised controlled trial (RCT) were compared with data from the previous AID-1 RCT involving six experienced endoscopists in an otherwise similar setting., Results: In 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; p<0.01 for non-inferiority and p=0.02 for superiority). Similar increases were seen in adenoma numbers per colonoscopy and in small and distal lesions. No differences were observed with regards to detection of non-neoplastic lesions. When pooling these data with those from the AID-1 study, use of CADe (RR 1.29; 95% CI: 1.16 to 1.42) and colonoscopy indication, but not the level of examiner experience (RR 1.02; 95% CI: 0.89 to 1.16) were associated with ADR differences in a multivariate analysis., Conclusions: In less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experience appears to play a minor role as determining factor for ADR., Trial Registration Number: NCT:04260321., Competing Interests: Competing interests: Conflict of interest statement/disclosure(s): All authors for equipment loan by Medtronic. AR and CH received consultancy fee from Medtronic. MBW provides consulting activity to Medtronic and Cosmo on behalf of Mayo Clinic and has equity interest in Virgo., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2022
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3. Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update.
- Author
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Veitch AM, Radaelli F, Alikhan R, Dumonceau JM, Eaton D, Jerrome J, Lester W, Nylander D, Thoufeeq M, Vanbiervliet G, Wilkinson JR, and Van Hooft JE
- Subjects
- Anticoagulants adverse effects, Atrial Fibrillation prevention & control, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Cholangiopancreatography, Endoscopic Retrograde methods, Cholangiopancreatography, Endoscopic Retrograde standards, Endoscopy adverse effects, Endoscopy methods, Gastrointestinal Hemorrhage prevention & control, Gastroscopy adverse effects, Gastroscopy methods, Gastroscopy standards, Humans, Platelet Aggregation Inhibitors adverse effects, Risk Factors, Thrombosis prevention & control, Anticoagulants therapeutic use, Endoscopy standards, Platelet Aggregation Inhibitors therapeutic use
- Abstract
This is a collaboration between the British Society of Gastroenterology (BSG) and the European Society of Gastrointestinal Endoscopy (ESGE), and is a scheduled update of their 2016 guideline on endoscopy in patients on antiplatelet or anticoagulant therapy. The guideline development committee included representatives from the British Society of Haematology, the British Cardiovascular Intervention Society, and two patient representatives from the charities Anticoagulation UK and Thrombosis UK, as well as gastroenterologists. The process conformed to AGREE II principles and the quality of evidence and strength of recommendations were derived using GRADE methodology. Prior to submission for publication, consultation was made with all member societies of ESGE, including BSG. Evidence-based revisions have been made to the risk categories for endoscopic procedures, and to the categories for risks of thrombosis. In particular a more detailed risk analysis for atrial fibrillation has been employed, and the recommendations for direct oral anticoagulants have been strengthened in light of trial data published since the previous version. A section has been added on the management of patients presenting with acute GI haemorrhage. Important patient considerations are highlighted. Recommendations are based on the risk balance between thrombosis and haemorrhage in given situations., Competing Interests: Competing interests: FR has received speaker fees from Bristol-Meyers Squibb, Pfizer and Boehringer Ingelheim. Dr Alikhan has received fees from Alexion, Bayer, Boehringer Ingelheim, Bristol-Meyers Squibb, Daiichi, Pfizer and Portola. WL has received speaker fees from Sanofi Aventis and Leo Pharma, speaker fees and advisory board fees from Bayer, Daichii Sankyo, Pfizer and Boehringer Ingelheim, and support to attend a scientific meeting from Boehringer Ingelheim. JEV-H has received departmental research grant support from Cook Medical and Abbott, lecture fees from Medtronics and Cook Medical, and consultancy fees from Boston Scientific and Olympus., (© 2021 European Society of Gastrointestinal Endoscopy, British Society of Gastroenterology, the Author(s) or their employer(s).)
- Published
- 2021
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4. Periendoscopic management of direct oral anticoagulants: a prospective cohort study.
- Author
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Radaelli F, Fuccio L, Paggi S, Hassan C, Repici A, Rondonotti E, Semeraro R, Di Leo M, Anderloni A, Amato A, Trovato C, Bravi I, Buda A, de Bellis M, D'Angelo V, Segato S, Tarantino O, Musso A, Fasoli R, Frazzoni L, Liverani E, Fabbri C, Di Giulio E, Esposito G, Pigò F, Iannone A, and Dentali F
- Subjects
- Administration, Oral, Aged, Anticoagulants administration & dosage, Cohort Studies, Elective Surgical Procedures, Endoscopy, Gastrointestinal methods, Female, Follow-Up Studies, Gastrointestinal Hemorrhage physiopathology, Humans, Italy, Male, Middle Aged, Perioperative Care methods, Prospective Studies, Risk Assessment, Stroke prevention & control, Thromboembolism prevention & control, Time Factors, Treatment Outcome, Withholding Treatment, Anticoagulants adverse effects, Endoscopy, Gastrointestinal adverse effects, Gastrointestinal Hemorrhage etiology, Patient Safety
- Abstract
Objective: To assess the frequency of adverse events associated with periendoscopic management of direct oral anticoagulants (DOACs) in patients undergoing elective GI endoscopy and the efficacy and safety of the British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) recommendations (NCT02734316)., Design: Consecutive patients on DOACs scheduled for elective GI endoscopy were prospectively included. The timing of DOAC interruption and resumption before and after the procedures were recorded, along with clinical and procedural data. Procedures were stratified into low-risk and high-risk for GI-related bleeding, and patients into low-risk and high-risk for thromboembolic events. Patients were followed-up for 30 days for major and clinically relevant non-major bleeding events (CRNMB), arterial and venous thromboembolism and death., Results: Of 529 patients, 38% and 62% underwent high-risk and low-risk procedures, respectively. There were 45 (8.5%; 95% CI 6.3% to 11.2%) major or CRNMB events and 2 (0.4%; 95% CI 0% to 1.4%) thromboembolic events (transient ischaemic attacks). Overall, the incidence of bleeding events was 1.8% (95% CI 0.7% to 4%) and 19.3% (95% CI 14.1% to 25.4%) in low-risk and high-risk procedures, respectively. For high-risk procedures, the incidence of intraprocedural bleeding was similar in patients who interrupted anticoagulation according to BSG/ESGE guidelines or earlier (10.3%vs10.8%, p=0.99), with a trend for a lower risk as compared with those who stopped anticoagulation later (10.3%vs25%, p=0.07). The incidence of delayed bleeding appeared similar in patients who resumed anticoagulation according to BSG/ESGE guidelines or later (6.6%vs7.7%, p=0.76), but it tended to increase when DOAC was resumed earlier (14.4%vs6.6%, p=0.27). The risk of delayed major bleeding was significantly higher in patients receiving heparin bridging than in non-bridged ones (26.6%vs5.9%, p=0.017)., Conclusion: High-risk procedures in patients on DOACs are associated with a substantial risk of bleeding, further increased by heparin bridging. Adoption of the BSG/ESGE guidelines in periendoscopic management of DOACs seems to result in a favourable benefit/risk ratio., Trial Registration Number: NCT02734316; Pre-results., Competing Interests: Competing interests: FR received grants outside the submitted work from BMS/Pfizer and Boehringer Ingelheim. FD received grants outside the submitted work from BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, Roche and Sanofi., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2019
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5. Full-spectrum (FUSE) versus standard forward-viewing colonoscopy in an organised colorectal cancer screening programme.
- Author
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Hassan C, Senore C, Radaelli F, De Pretis G, Sassatelli R, Arrigoni A, Manes G, Amato A, Anderloni A, Armelao F, Mondardini A, Spada C, Omazzi B, Cavina M, Miori G, Campanale C, Sereni G, Segnan N, and Repici A
- Subjects
- Aged, Female, Humans, Italy, Male, Middle Aged, Models, Statistical, Single-Blind Method, Adenoma diagnostic imaging, Colonoscopy methods, Colorectal Neoplasms diagnostic imaging, Early Detection of Cancer methods, Mass Screening methods
- Abstract
Objective: Miss rate of polyps has been shown to be substantially lower with full-spectrum endoscopy (FUSE) compared with standard forward-viewing (SFV) colonoscopy in a tandem study at per polyp analysis. However, there is uncertainty on whether FUSE is also associated with a higher detection rate of colorectal neoplasia, especially advanced lesions, in per patient analysis., Methods: Consecutive subjects undergoing colonoscopy following a positive faecal immunochemical test (FIT) by experienced endoscopists and performed in the context of a regional colorectal cancer population-screening programme were randomised between colonoscopy with either FUSE or SFV colonoscopy in seven Italian centres. Randomisation was stratified by gender, age group and screening history. Primary outcomes included detection rates of advanced adenomas (A-ADR), adenomas (ADR) and sessile-serrated polyps (SSPDR)., Results: Of 741 eligible subjects, 658 were randomised to either FUSE (n=328) or SFV (n=330) colonoscopy and included in the analysis. Overall, 293/658 and 143/658 subjects had at least one adenoma (ADR 44.5%) and advanced adenoma (A-ADR 21.7%), respectively, while SSP was the most advanced lesion in 18 cases (SSPDR 2.7%). ADR and A-ADR were 43.6% and 19.5% in the FUSE arm, and 45.5% and 23.9% in the SFV arm, with no difference for both ADR (OR for FUSE: 0.96, 95% CI 0.81 to 1.14) and A-ADR (OR for FUSE: 0.82, 95% CI 0.61 to 1.09). No difference in SSPDR or multiplicity was detected between the two arms. In the per polyp analysis, the mean number of adenomas and proximal adenomas per patient was 0.81±1.25 and 0.47±0.93 in the FUSE arm, and 0.85±1.33 and 0.48±0.96 in the SFV colonoscopy arm (p=NS for both comparisons)., Conclusions: No statistically significant difference in ADR and A-ADR between FUSE and SFV colonoscopy was detected in a per patient analysis in FIT-positive patients., Trial Registration Number: ISRCTN10357435., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)
- Published
- 2017
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6. Barriers against split-dose bowel preparation for colonoscopy.
- Author
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Radaelli F, Paggi S, Repici A, Gullotti G, Cesaro P, Rotondano G, Cugia L, Trovato C, Spada C, Fuccio L, Occhipinti P, Pace F, Fabbri C, Buda A, Manes G, Feliciangeli G, Manno M, Barresi L, Anderloni A, Dulbecco P, Rogai F, Amato A, Senore C, and Hassan C
- Subjects
- Aged, Appointments and Schedules, Colonoscopy, Educational Status, Female, Humans, Male, Middle Aged, Prospective Studies, Sex Factors, Surveys and Questionnaires, Time Factors, Adenoma diagnosis, Cathartics administration & dosage, Colorectal Neoplasms diagnosis, Health Knowledge, Attitudes, Practice, Patient Compliance statistics & numerical data, Polyethylene Glycols administration & dosage
- Abstract
Objective: Although split regimen is associated with higher adenoma detection and is recommended for elective colonoscopy, its adoption remains suboptimal. The identification of patient-related barriers may improve its implementation. Our aim was to assess patients' attitude towards split regimen and patient-related factors associated with its uptake., Design: In a multicentre, prospective study, outpatients undergoing colonoscopy from 8:00 to 14:00 were given written instructions for 4 L polyethylene glycol bowel preparation, offering the choice between split-dose and day-before regimens and emphasising the superiority of split regimen on colonoscopy outcomes. Uptake of split regimen and association with patient-related factors were explored by a 20-item questionnaire., Results: Of the 1447 patients (mean age 59.2±13.5 years, men 54.3%), 61.7% and 38.3% chose a split-dose and day-before regimens, respectively. A linear correlation was observed between time of colonoscopy appointments and split-dose uptake, from 27.3% in 8:00 patients to 96% in 14:00 patients (p<0.001, χ
2 for linear trend). At multivariate analysis, colonoscopy appointment before 10:00 (OR 0.14, 95% CI 0.11 to 0.18), travel time to endoscopy service >1 h (OR 0.55, 95% CI 0.38 to 0.79), low education level (OR 0.72, 95% CI 0.54 to 0.96) and female gender (OR 0.74, 95% CI 0.58 to 0.95) were inversely correlated with the uptake of split-dose. Overall, the risk of travel interruption and faecal incontinence was slightly increased in split regimen patients (3.0% vs 1.4% and 1.5% vs 0.9%, respectively; p=NS). Split regimen was an independent predictor of adequate colon cleansing (OR 3.34, 95% CI 2.40 to 4.63) and polyp detection (OR 1.46, 95% CI 1.11 to 1.92)., Conclusion: Patient attitude towards split regimen is suboptimal, especially for early morning examinations. Interventions to improve patient compliance (ie, policies to reorganise colonoscopy timetable, educational initiatives for patient and healthcare providers) should be considered., Trial Registration Number: NCT02287051; pre-result., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)- Published
- 2017
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7. Split-dose preparation for colonoscopy increases adenoma detection rate: a randomised controlled trial in an organised screening programme.
- Author
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Radaelli F, Paggi S, Hassan C, Senore C, Fasoli R, Anderloni A, Buffoli F, Savarese MF, Spinzi G, Rex DK, and Repici A
- Subjects
- Adenoma pathology, Aged, Colonic Neoplasms pathology, Colonoscopy standards, Female, Humans, Male, Middle Aged, Patient Compliance, Single-Blind Method, Tumor Burden, Adenoma diagnosis, Cathartics administration & dosage, Colonic Neoplasms diagnosis, Colonoscopy methods, Early Detection of Cancer, Polyethylene Glycols administration & dosage
- Abstract
Objective: Although a split regimen of bowel preparation has been associated with higher levels of bowel cleansing, it is still uncertain whether it has a favourable effect on the adenoma detection rate (ADR). The present study was aimed at evaluating whether a split regimen was superior to the traditional 'full-dose, day-before' regimen in terms of ADR., Design: In a multicentre, randomised, endoscopist-blinded study, 50-69-year-old subjects undergoing first colonoscopy after positive-faecal immunochemical test within an organised colorectal cancer organised screening programmes were 1:1 randomised to receive low-volume 2-L polyethylene glycol (PEG)-ascorbate solution in a 'split-dose' (Split-Dose Group, SDG) or 'day-before' regimen (Day-Before Group, DBG). The primary endpoint was the proportion of subjects with at least one adenoma. Secondary endpoints were the detection rates of advanced adenomas and serrated lesions at per-patient analysis and the total number of lesions., Results: 690 subjects were included in the study. At per-patient analysis, the proportion of subjects with at least one adenoma was significantly higher in the SDG than in the DBG (183/345, 53.0% vs 141/345, 40.9%, relative risk (RR) 1.22, 95% CI 1.03 to 1.46); corresponding figures for advanced adenomas were 26.4% (91/345) versus 20.0% (69/345, RR 1.35, 95% CI 1.06 to 1.73). At per-polyp analysis, the total numbers of both adenomas and advanced adenomas per subject were significantly higher in the SDG (1.15 vs 0.8, p <0.001; 0.36 vs 0.22, p<0.001)., Conclusions: In an organised screening setting, the adoption of a split regimen resulted into a higher detection rate of clinically relevant neoplastic lesions, thus improving the effectiveness of colonoscopy. Based on such evidence, the adoption of a split regimen for colonoscopy should be strongly recommended., Clinical Trial Registration Number: NCT02178033., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)
- Published
- 2017
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8. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines.
- Author
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Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, and Dumonceau JM
- Subjects
- Anticoagulants therapeutic use, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Clinical Decision-Making, Drug Therapy, Combination, Endoscopic Ultrasound-Guided Fine Needle Aspiration adverse effects, Gastrointestinal Hemorrhage etiology, Humans, Platelet Aggregation Inhibitors therapeutic use, Risk Assessment, Risk Factors, Thrombosis prevention & control, Anticoagulants adverse effects, Endoscopy, Gastrointestinal adverse effects, Gastrointestinal Hemorrhage prevention & control, Platelet Aggregation Inhibitors adverse effects
- Abstract
The risk of endoscopy in patients on antithrombotics depends on the risks of procedural haemorrhage versus thrombosis due to discontinuation of therapy. P2Y12 RECEPTOR ANTAGONISTS CLOPIDOGREL, PRASUGREL, TICAGRELOR: For low-risk endoscopic procedures we recommend continuing P2Y12 receptor antagonists as single or dual antiplatelet therapy (low quality evidence, strong recommendation); For high-risk endoscopic procedures in patients at low thrombotic risk, we recommend discontinuing P2Y12 receptor antagonists five days before the procedure (moderate quality evidence, strong recommendation). In patients on dual antiplatelet therapy, we suggest continuing aspirin (low quality evidence, weak recommendation). For high-risk endoscopic procedures in patients at high thrombotic risk, we recommend continuing aspirin and liaising with a cardiologist about the risk/benefit of discontinuation of P2Y12 receptor antagonists (high quality evidence, strong recommendation)., Warfarin: The advice for warfarin is fundamentally unchanged from British Society of Gastroenterology (BSG) 2008 guidance., Direct Oral Anticoagulants Doac: For low-risk endoscopic procedures we suggest omitting the morning dose of DOAC on the day of the procedure (very low quality evidence, weak recommendation); For high-risk endoscopic procedures, we recommend that the last dose of DOAC be taken ≥48 h before the procedure (very low quality evidence, strong recommendation). For patients on dabigatran with CrCl (or estimated glomerular filtration rate, eGFR) of 30-50 mL/min we recommend that the last dose of DOAC be taken 72 h before the procedure (very low quality evidence, strong recommendation). In any patient with rapidly deteriorating renal function a haematologist should be consulted (low quality evidence, strong recommendation)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)
- Published
- 2016
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