29 results on '"F Radaelli"'
Search Results
2. How to optimize the detection of serrated lesions: old tools for a new story?
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Radaelli F
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- Humans, Colonoscopy, Colonic Polyps diagnosis, Colonic Neoplasms, Colorectal Neoplasms diagnosis
- Abstract
Competing Interests: The authors declare that they have no conflict of interest.
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- 2023
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3. Clinical value of alarm features for colorectal cancer: a meta-analysis.
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Frazzoni L, Laterza L, La Marca M, Zagari RM, Radaelli F, Hassan C, Repici A, Facciorusso A, Gkolfakis P, Spada C, Triantafyllou K, Bazzoli F, Dinis-Ribeiro M, and Fuccio L
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- Male, Humans, Adult, Middle Aged, Aged, Aged, 80 and over, Rectum, Colonoscopy, Gastrointestinal Hemorrhage etiology, Weight Loss, Early Detection of Cancer, Colorectal Neoplasms diagnosis, Anemia etiology
- Abstract
Background: Colorectal cancer (CRC) is a common neoplasm in Western countries. Prioritizing access to colonoscopy appears of critical relevance. Alarm features are considered to increase the likelihood of CRC. Our aim was to assess the diagnostic performance of alarm features for CRC diagnosis., Methods: We performed a systematic review and meta-analysis of studies reporting the diagnostic accuracy of alarm features (rectal bleeding, anemia, change in bowel habit, and weight loss) for CRC, published up to September 2021. Colonoscopy was required as the reference diagnostic test. Diagnostic accuracy measures were pooled by a bivariate mixed-effects regression model. The number needed to scope (NNS; i. e. the number of patients who need to undergo colonoscopy to diagnose one CRC) according to each alarm feature was calculated., Results: 31 studies with 45 100 patients (mean age 31-88 years; men 36 %-63 %) were included. The prevalence of CRC ranged from 0.2 % to 22 %. Sensitivity was suboptimal, ranging from 12.4 % for weight loss to 49 % for rectal bleeding, whereas specificity ranged from 69.8 % for rectal bleeding to 91.9 % for weight loss. Taken individually, rectal bleeding and anemia would be the only practical alarm features mandating colonoscopy (NNS 5.3 and 6.7, respectively)., Conclusions: When considered independently, alarm features have variable accuracy for CRC, given the high heterogeneity of study populations reflected by wide variability in CRC prevalence. Rectal bleeding and anemia are the most practical to select patients for colonoscopy. Integration of alarm features in a comprehensive evaluation of patients should be considered., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)
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- 2023
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4. Artificial intelligence-assisted optical diagnosis for the resect-and-discard strategy in clinical practice: the Artificial intelligence BLI Characterization (ABC) study.
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Rondonotti E, Hassan C, Tamanini G, Antonelli G, Andrisani G, Leonetti G, Paggi S, Amato A, Scardino G, Di Paolo D, Mandelli G, Lenoci N, Terreni N, Andrealli A, Maselli R, Spadaccini M, Galtieri PA, Correale L, Repici A, Di Matteo FM, Ambrosiani L, Filippi E, Sharma P, and Radaelli F
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- Humans, Artificial Intelligence, Colonoscopy, Colon pathology, Narrow Band Imaging, Colonic Polyps diagnostic imaging, Colonic Polyps surgery, Adenoma diagnostic imaging, Adenoma surgery, Colorectal Neoplasms diagnostic imaging, Colorectal Neoplasms surgery
- Abstract
Background: Optical diagnosis of colonic polyps is poorly reproducible outside of high volume referral centers. The present study aimed to assess whether real-time artificial intelligence (AI)-assisted optical diagnosis is accurate enough to implement the leave-in-situ strategy for diminutive (≤ 5 mm) rectosigmoid polyps (DRSPs)., Methods: Consecutive colonoscopy outpatients with ≥ 1 DRSP were included. DRSPs were categorized as adenomas or nonadenomas by the endoscopists, who had differing expertise in optical diagnosis, with the assistance of a real-time AI system (CAD-EYE). The primary end point was ≥ 90 % negative predictive value (NPV) for adenomatous histology in high confidence AI-assisted optical diagnosis of DRSPs (Preservation and Incorporation of Valuable endoscopic Innovations [PIVI-1] threshold), with histopathology as the reference standard. The agreement between optical- and histology-based post-polypectomy surveillance intervals (≥ 90 %; PIVI-2 threshold) was also calculated according to European Society of Gastrointestinal Endoscopy (ESGE) and United States Multi-Society Task Force (USMSTF) guidelines., Results: Overall 596 DRSPs were retrieved for histology in 389 patients; an AI-assisted high confidence optical diagnosis was made in 92.3 %. The NPV of AI-assisted optical diagnosis for DRSPs (PIVI-1) was 91.0 % (95 %CI 87.1 %-93.9 %). The PIVI-2 threshold was met with 97.4 % (95 %CI 95.7 %-98.9 %) and 92.6 % (95 %CI 90.0 %-95.2 %) of patients according to ESGE and USMSTF, respectively. AI-assisted optical diagnosis accuracy was significantly lower for nonexperts (82.3 %, 95 %CI 76.4 %-87.3 %) than for experts (91.9 %, 95 %CI 88.5 %-94.5 %); however, nonexperts quickly approached the performance levels of experts over time., Conclusion: AI-assisted optical diagnosis matches the required PIVI thresholds. This does not however offset the need for endoscopists' high level confidence and expertise. The AI system seems to be useful, especially for nonexperts., Competing Interests: E. Rondonotti has received speakerʼs honoraria from Fujifilm Co., is a member of the Fujifilm Co. expert group, and has provided consultancy to Medtronic Co. C. Hassan has equipment on loan from Fujifilm Co. S. Paggi, A. Amato, and R. Maselli have received speakerʼs honoraria from Fujifilm Co. A. Repici has provided consultancy and has received research grants, not related to the present study, from Fujifilm Co., Medtronic, and Boston Scientific Co. and has provided consultancy to Cosmo Pharmaceuticals S.p.A. and Erbe Elektromedizin GmbH. F. Radaelli has received speakerʼs honoraria and a research grant, not related to the present study, from Fujifilm Co. The remaining authors declare that they have no conflict of interest., (Thieme. All rights reserved.)
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- 2023
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5. Efficacy of a computer-aided detection system in a fecal immunochemical test-based organized colorectal cancer screening program: a randomized controlled trial (AIFIT study).
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Rondonotti E, Di Paolo D, Rizzotto ER, Alvisi C, Buscarini E, Spadaccini M, Tamanini G, Paggi S, Amato A, Scardino G, Romeo S, Alicante S, Ancona F, Guido E, Marzo V, Chicco F, Agazzi S, Rosa C, Correale L, Repici A, Hassan C, and Radaelli F
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- Male, Humans, Middle Aged, Early Detection of Cancer, Colonoscopy, Mass Screening, Colorectal Neoplasms diagnosis, Adenoma diagnosis
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Background: Computer-aided detection (CADe) increases adenoma detection in primary screening colonoscopy. The potential benefit of CADe in a fecal immunochemical test (FIT)-based colorectal cancer (CRC) screening program is unknown. This study assessed whether use of CADe increases the adenoma detection rate (ADR) in a FIT-based CRC screening program., Methods: In a multicenter, randomized trial, FIT-positive individuals aged 50-74 years undergoing colonoscopy, were randomized (1:1) to receive high definition white-light (HDWL) colonoscopy, with or without a real-time deep-learning CADe by endoscopists with baseline ADR > 25 %. The primary outcome was ADR. Secondary outcomes were mean number of adenomas per colonoscopy (APC) and advanced adenoma detection rate (advanced-ADR). Subgroup analysis according to baseline endoscopists' ADR (≤ 40 %, 41 %-45 %, ≥ 46 %) was also performed., Results: 800 individuals (median age 61.0 years [interquartile range 55-67]; 409 men) were included: 405 underwent CADe-assisted colonoscopy and 395 underwent HDWL colonoscopy alone. ADR and APC were significantly higher in the CADe group than in the HDWL arm: ADR 53.6 % (95 %CI 48.6 %-58.5 %) vs. 45.3 % (95 %CI 40.3 %-50.45 %; RR 1.18; 95 %CI 1.03-1.36); APC 1.13 (SD 1.54) vs. 0.90 (SD 1.32; P = 0.03). No significant difference in advanced-ADR was found (18.5 % [95 %CI 14.8 %-22.6 %] vs. 15.9 % [95 %CI 12.5 %-19.9 %], respectively). An increase in ADR was observed in all endoscopist groups regardless of baseline ADR., Conclusions: Incorporating CADe significantly increased ADR and APC in the framework of a FIT-based CRC screening program. The impact of CADe appeared to be consistent regardless of endoscopist baseline ADR., Competing Interests: E. Rondonotti has received speaker honoraria from Fujifilm Co., is a member of Fujifilm Co. expert group, and is a consultant for Medtronic Co. S. Paggi and A. Amato have received speaker honoraria from Fujifilm Co. F. Radaelli has received speaker honoraria and a research grant (not related to the present study) from Fujifilm Co. C. Hassan C has received equipment on loan from Fujifilm Co. A. Repici is a consultant for and has received research grants (not related to the present study) from Fujifilm Co., Medtronic plc, and Boston Scientific Co; he is also a consultant for Cosmo Pharmaceuticals S.p.A. and Erbe Elektromedizin GmbH. The remaining authors declare that they have no conflict of interest., (Thieme. All rights reserved.)
- Published
- 2022
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6. Efficacy of lumen-apposing metal stents or self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy: a systematic review and meta-analysis.
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Amato A, Sinagra E, Celsa C, Enea M, Buda A, Vieceli F, Scaramella L, Belletrutti P, Fugazza A, Cammà C, Radaelli F, Repici A, and Anderloni A
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- Drainage, Endosonography, Humans, Stents adverse effects, Treatment Outcome, Ultrasonography, Interventional, Choledochostomy adverse effects, Self Expandable Metallic Stents adverse effects
- Abstract
Background: Endoscopic ultrasound (EUS)-guided biliary drainage is becoming an option for palliation of malignant biliary obstruction. Lumen-apposing metal stents (LAMS) are replacing self-expandable metal stents (SEMS). The aim of this meta-analysis was to evaluate the efficacy and safety of LAMS and SEMS for EUS-guided choledochoduodenostomy (EUS-CDS)., Methods: A meta-analysis was performed using PRISMA protocols. Electronic databases were searched for studies on EUS-CDS. The primary outcome was clinical success. Secondary outcomes were technical success, reintervention, and adverse events. We used the random effects model with the DerSimonian-Laird estimation, and the results were depicted using forest plots. Subgroup analyses were also performed with data stratified by selected variable., Results: Overall, 31 studies (820 patients) were included. The pooled rates of clinical and technical success were 93.6 % (95 % confidence interval [CI] 88.6 %-96.5 %) and 94.8 % (95 %CI 90.2 %-97.3 %) for LAMS, and 91.7 % (95 %CI 88.1 %-94.2 %) and 92.7 % (95 %CI 89.9 %-94.9 %) for SEMS, respectively. The pooled rates of adverse events were 17.1 % (95 %CI 12.5 %-22.8 %) for LAMS and 18.3 % (95 %CI 14.3 %-23.0 %) for SEMS. The pooled rates of reintervention were 10.9 % (95 %CI 7.7 %-15.3 %) for LAMS and 13.9 % (95 %CI 9.6 %-19.7 %) for SEMS. Subgroup analyses confirmed these results., Conclusions: This meta-analysis showed that LAMS and SEMS are comparable in terms of efficacy for EUS-CDS. Clinical and technical success, post-procedure adverse events, and reintervention rates were similar between LAMS and SEMS use; however, adverse events require further investigation., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)
- Published
- 2021
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7. Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update.
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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
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- Anticoagulants, Endoscopy, Gastrointestinal, Gastrointestinal Hemorrhage chemically induced, Humans, Gastroenterology, Thrombosis etiology, Thrombosis prevention & control
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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: Dr Radaelli 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. Dr Lester 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. Prof Van- Hooft 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. None of the remaining authors have competing interests to declare., (European Society of Gastrointestinal Endoscopy, British Society of Gastroenterology, the Author(s) or their employer(s). This is an open access article published by Thieme and BMJ Publishing Group Ltd under the terms of the Creative Commons Attribution Non Commercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes. (https://creativecommons.org/licenses/by-nc/4.0/).)
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- 2021
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8. Correction: Diagnosis and management of acute lower gastrointestinal bleeding: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.
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Triantafyllou K, Gkolfakis P, Gralnek IM, Oakland K, Manes G, Radaelli F, Awadie H, Camus Duboc M, Christodoulou D, Fedorov E, Guy RJ, Hollenbach M, Ibrahim M, Neeman Z, Regge D, Rodriguez de Santiago E, Tham TC, Thelin-Schmidt P, and van Hooft JE
- Abstract
Competing Interests: Disclosure The authors report no conflicts of interest in this work.
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- 2021
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9. Diagnosis and management of acute lower gastrointestinal bleeding: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.
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Triantafyllou K, Gkolfakis P, Gralnek IM, Oakland K, Manes G, Radaelli F, Awadie H, Camus Duboc M, Christodoulou D, Fedorov E, Guy RJ, Hollenbach M, Ibrahim M, Neeman Z, Regge D, Rodriguez de Santiago E, Tham TC, Thelin-Schmidt P, and van Hooft JE
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- Colonoscopy, Humans, Endoscopy, Gastrointestinal, Gastrointestinal Hemorrhage diagnosis, Gastrointestinal Hemorrhage etiology, Gastrointestinal Hemorrhage therapy
- Abstract
1: ESGE recommends that the initial assessment of patients presenting with acute lower gastrointestinal bleeding should include: a history of co-morbidities and medications that promote bleeding; hemodynamic parameters; physical examination (including digital rectal examination); and laboratory markers. A risk score can be used to aid, but should not replace, clinician judgment.Strong recommendation, low quality evidence. 2 : ESGE recommends that, in patients presenting with a self-limited bleed and no adverse clinical features, an Oakland score of ≤ 8 points can be used to guide the clinician decision to discharge the patient for outpatient investigation.Strong recommendation, moderate quality evidence. 3 : ESGE recommends, in hemodynamically stable patients with acute lower gastrointestinal bleeding and no history of cardiovascular disease, a restrictive red blood cell transfusion strategy, with a hemoglobin threshold of ≤ 7 g/dL prompting red blood cell transfusion. A post-transfusion target hemoglobin concentration of 7-9 g/dL is desirable.Strong recommendation, low quality evidence. 4 : ESGE recommends, in hemodynamically stable patients with acute lower gastrointestinal bleeding and a history of acute or chronic cardiovascular disease, a more liberal red blood cell transfusion strategy, with a hemoglobin threshold of ≤ 8 g/dL prompting red blood cell transfusion. A post-transfusion target hemoglobin concentration of ≥ 10 g/dL is desirable.Strong recommendation, low quality evidence. 5: ESGE recommends that, in patients with major acute lower gastrointestinal bleeding, colonoscopy should be performed sometime during their hospital stay because there is no high quality evidence that early colonoscopy influences patient outcomes.Strong recommendation, low quality of evidence. 6 : ESGE recommends that patients with hemodynamic instability and suspected ongoing bleeding undergo computed tomography angiography before endoscopic or radiologic treatment to locate the site of bleeding.Strong recommendation, low quality evidence. 7 : ESGE recommends withholding vitamin K antagonists in patients with major lower gastrointestinal bleeding and correcting their coagulopathy according to the severity of bleeding and their thrombotic risk. In patients with hemodynamic instability, we recommend administering intravenous vitamin K and four-factor prothrombin complex concentrate (PCC), or fresh frozen plasma if PCC is not available.Strong recommendation, low quality evidence. 8 : ESGE recommends temporarily withholding direct oral anticoagulants at presentation in patients with major lower gastrointestinal bleeding.Strong recommendation, low quality evidence. 9: ESGE does not recommend withholding aspirin in patients taking low dose aspirin for secondary cardiovascular prevention. If withheld, low dose aspirin should be resumed, preferably within 5 days or even earlier if hemostasis is achieved or there is no further evidence of bleeding.Strong recommendation, moderate quality evidence. 10: ESGE does not recommend routinely discontinuing dual antiplatelet therapy (low dose aspirin and a P2Y12 receptor antagonist) before cardiology consultation. Continuation of the aspirin is recommended, whereas the P2Y12 receptor antagonist can be continued or temporarily interrupted according to the severity of bleeding and the ischemic risk. If interrupted, the P2Y12 receptor antagonist should be restarted within 5 days, if still indicated.Strong recommendation, low quality evidence., Competing Interests: M. Camus Duboc has provided consultancy to Boston Scientific (2017–2019) and Cook Medical (2019); she received editorial fees from HepatoGastroentérologie et Oncologie digestive (2020). I.M. Gralnek has provided consultancy to and been on the advisory board of MotusGI (2016 to present) and has provided consultancy to Boston Scientific (2020 to present) and Medtronic (2021). M. Hollenbach has provided consultancy and received an honorarium for expert group membership from Fuji (2020 to present). J.E. van Hooft has provided consultancy to Boston Scientific (2014 to 2017) and Olympus (2021), has received lecture fees from Medtronics (2014, 2015, and 2019) and Cook Medical (2019); her department has received research grants from Cook Medical (2014 to 2019) and Abbott (2014 to 2017). H. Awadie, D. Christodoulou, E. Fedorov, P. Gkolfakis, R.J. Guy, M. Ibrahim, G. Manes, Z. Neeman, K. Oakland, F. Radaelli, D. Regge, E. Rodriguez de Santiago, T.C. Tham, P. Thelin-Schmidt, and K. Triantafyllou declare that they have no conflict of interest., (European Society of Gastrointestinal Endoscopy. All rights reserved.)
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- 2021
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10. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021.
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Gralnek IM, Stanley AJ, Morris AJ, Camus M, Lau J, Lanas A, Laursen SB, Radaelli F, Papanikolaou IS, Cúrdia Gonçalves T, Dinis-Ribeiro M, Awadie H, Braun G, de Groot N, Udd M, Sanchez-Yague A, Neeman Z, and van Hooft JE
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- Gastrointestinal Hemorrhage diagnosis, Gastrointestinal Hemorrhage etiology, Gastrointestinal Hemorrhage therapy, Humans, Endoscopy, Gastrointestinal, Hemostasis, Endoscopic
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1: ESGE recommends in patients with acute upper gastrointestinal hemorrhage (UGIH) the use of the Glasgow-Blatchford Score (GBS) for pre-endoscopy risk stratification. Patients with GBS ≤ 1 are at very low risk of rebleeding, mortality within 30 days, or needing hospital-based intervention and can be safely managed as outpatients with outpatient endoscopy.Strong recommendation, moderate quality evidence. 2: ESGE recommends that in patients with acute UGIH who are taking low-dose aspirin as monotherapy for secondary cardiovascular prophylaxis, aspirin should not be interrupted. If for any reason it is interrupted, aspirin should be re-started as soon as possible, preferably within 3-5 days.Strong recommendation, moderate quality evidence. 3: ESGE recommends that following hemodynamic resuscitation, early (≤ 24 hours) upper gastrointestinal (GI) endoscopy should be performed. Strong recommendation, high quality evidence. 4: ESGE does not recommend urgent (≤ 12 hours) upper GI endoscopy since as compared to early endoscopy, patient outcomes are not improved. Strong recommendation, high quality evidence. 5: ESGE recommends for patients with actively bleeding ulcers (FIa, FIb), combination therapy using epinephrine injection plus a second hemostasis modality (contact thermal or mechanical therapy). Strong recommendation, high quality evidence. 6: ESGE recommends for patients with an ulcer with a nonbleeding visible vessel (FIIa), contact or noncontact thermal therapy, mechanical therapy, or injection of a sclerosing agent, each as monotherapy or in combination with epinephrine injection. Strong recommendation, high quality evidence. 7 : ESGE suggests that in patients with persistent bleeding refractory to standard hemostasis modalities, the use of a topical hemostatic spray/powder or cap-mounted clip should be considered. Weak recommendation, low quality evidence. 8: ESGE recommends that for patients with clinical evidence of recurrent peptic ulcer hemorrhage, use of a cap-mounted clip should be considered. In the case of failure of this second attempt at endoscopic hemostasis, transcatheter angiographic embolization (TAE) should be considered. Surgery is indicated when TAE is not locally available or after failed TAE. Strong recommendation, moderate quality evidence. 9: ESGE recommends high dose proton pump inhibitor (PPI) therapy for patients who receive endoscopic hemostasis and for patients with FIIb ulcer stigmata (adherent clot) not treated endoscopically. (A): PPI therapy should be administered as an intravenous bolus followed by continuous infusion (e. g., 80 mg then 8 mg/hour) for 72 hours post endoscopy. (B): High dose PPI therapies given as intravenous bolus dosing (twice-daily) or in oral formulation (twice-daily) can be considered as alternative regimens.Strong recommendation, high quality evidence. 10: ESGE recommends that in patients who require ongoing anticoagulation therapy following acute NVUGIH (e. g., peptic ulcer hemorrhage), anticoagulation should be resumed as soon as the bleeding has been controlled, preferably within or soon after 7 days of the bleeding event, based on thromboembolic risk. The rapid onset of action of direct oral anticoagulants (DOACS), as compared to vitamin K antagonists (VKAs), must be considered in this context.Strong recommendation, low quality evidence., Competing Interests: N. de Groot has worked with the NUMDL group on a national guideline on GI bleeding (January to June 2017). M. Dinis-Ribeiro has provided consultancy to Medtronic (October 2020); he is a Co-Editor-in-Chief of the journal Endoscopy. I.M. Gralnek is a consultant to Boston Scientific, Medtronic, Motus GI, Vifor Pharma, Simbionix, and Neurogastrx; he is also on the medical advisory board of Motus GI and has received research funding from them and from OnePass, AstraZeneca and CheckCap; he has also been a speaker for Vifor Pharma and 3D Matrix. A. Lanas has provided consultancy to Bayer AG (2018 to 2020). A.J. Morris serves on an advisory board for Medtronic (October 2020, ongoing); he is an unpaid committee member and a guideline lead for the British Society of Gastroenterology (BSG); he has received a fee for a commissioned article in Medicine International journal (2019). I.S. Papanikolaou has received a consultancy fee from Boston Scientific (25 January 2018 and 21 October 2018); he has received travel grants from Takeda Hellas (10–13 October 2019 and 3–6 December 2020). F. Radaelli has served on an advisory board and been a speaker for Pfizer/BMS (2019 to 2020); he has been a speaker for Boehringer Ingelheim (2019 to 2020). A. Sanchez-Yague has received consultancy fees from Boston Scientific (2017 to 2019). J.E. van Hooft has received lecture fees from Medtronic (2014 to 2015, 2019) and Cook Medical (2019), and consultancy fees from Boston Scientific (2014 to 2017); her department has received research grants from Cook Medical (2014 to 2019), and Abbott (2014 to 2017). H. Awadie, G. Braun, M. Camus, T. Cúrdia Gonçalves, J. Lau, S.B. Laursen, Z. Neeman, A.J. Stanley, and M. Udd declare no competing interests., (European Society of Gastrointestinal Endoscopy. All rights reserved.)
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- 2021
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11. How to identify patients who are less likely to have metachronous neoplasms after a colon cancer: a predictive model.
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Frazzoni L, Laterza L, Mussetto A, Zagari RM, Trovato C, De Bellis M, Paggi S, Piccirelli S, Ricciardiello L, Cesaro P, Spada C, Dal Piaz G, La Marca M, Fabbian F, Petrella L, Smania V, Marone P, Tatangelo F, Bazzoli F, Radaelli F, Repici A, Hassan C, Scagliarini M, and Fuccio L
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- Colonoscopy, Humans, Prospective Studies, Retrospective Studies, Risk Factors, Colonic Neoplasms epidemiology, Colorectal Neoplasms, Neoplasms, Second Primary epidemiology
- Abstract
Background: Patients with prior colon cancer have increased risk of metachronous colorectal neoplasms; therefore, endoscopic surveillance is indicated. Current recommendations are not risk-stratified. We investigated predictive factors for colorectal neoplasms to build a model to spare colonoscopies for low-risk patients., Methods: This was a multicenter, retrospective study including patients who underwent surgery for colon cancer in 2001 - 2008 (derivation cohort) and 2009 - 2013 (validation cohort). A predictive model for neoplasm occurrence at second surveillance colonoscopy was developed and validated., Results: 421 and 203 patients were included in derivation and validation cohort, respectively. At second surveillance colonoscopy, 112 (26.6 %) and 55 (27.1 %) patients had metachronous neoplasms in derivation and validation groups; three cancers were detected in the latter. History of left-sided colon cancer (OR 1.64, 95 %CI 1.02 - 2.64), ≥ 1 advanced adenoma at index colonoscopy (OR 1.90, 95 %CI 1.05 - 3.43), and ≥ 1 adenoma at first surveillance colonoscopy (OR 2.06, 95 %CI 1.29 - 3.27) were independently predictive of metachronous colorectal neoplasms at second surveillance colonoscopy. For patients without such risk factors, diagnostic accuracy parameters were: 89.3 % (95 %CI 82.0 %-94.3 %) and 78.2 % (95 %CI 65.0 %-88.2 %) sensitivity, and 28.5 % (95 %CI 23.5 %-33.9 %) and 33.8 % (95 %CI 26.2 %-42.0 %) specificity in derivation and validation group, respectively. No cancer would be missed., Conclusions: Patients with prior left-sided colon cancer or ≥ 1 advanced adenoma at index colonoscopy or ≥ 1 adenoma at first surveillance colonoscopy had a significantly higher risk of neoplasms at second surveillance colonoscopy; patients without such factors had much lower risk and could safely skip the second surveillance colonoscopy. A prospective, multicenter validation study is needed., Competing Interests: The authors declare that they have no conflict of interest., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2020
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12. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.
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Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, and van Hooft JE
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- Endoscopy, Gastrointestinal, Humans, Pancreatic Ducts, Sphincterotomy, Endoscopic adverse effects, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Self Expandable Metallic Stents adverse effects
- Abstract
Prophylaxis: 1: ESGE recommends routine rectal administration of 100 mg of diclofenac or indomethacin immediately before endoscopic retrograde cholangiopancreatography (ERCP) in all patients without contraindications to nonsteroidal anti-inflammatory drug administration.Strong recommendation, moderate quality evidence. 2: ESGE recommends prophylactic pancreatic stenting in selected patients at high risk for post-ERCP pancreatitis (inadvertent guidewire insertion/opacification of the pancreatic duct, double-guidewire cannulation).Strong recommendation, moderate quality evidence. 3: ESGE suggests against routine endoscopic biliary sphincterotomy before the insertion of a single plastic stent or an uncovered/partially covered self-expandable metal stent for relief of biliary obstruction.Weak recommendation, moderate quality evidence. 4: ESGE recommends against the routine use of antibiotic prophylaxis before ERCP.Strong recommendation, moderate quality evidence. 5: ESGE suggests antibiotic prophylaxis before ERCP in the case of anticipated incomplete biliary drainage, for severely immunocompromised patients, and when performing cholangioscopy.Weak recommendation, moderate quality evidence. 6: ESGE suggests tests of coagulation are not routinely required prior to ERCP for patients who are not on anticoagulants and not jaundiced.Weak recommendation, low quality evidence., Treatment: 7: ESGE suggests against salvage pancreatic stenting in patients with post-ERCP pancreatitis.Weak recommendation, low quality evidence. 8: ESGE suggests temporary placement of a biliary fully covered self-expandable metal stent for post-sphincterotomy bleeding refractory to standard hemostatic modalities.Weak recommendation, low quality evidence. 9: ESGE suggests to evaluate patients with post-ERCP cholangitis by abdominal ultrasonography or computed tomography (CT) scan and, in the absence of improvement with conservative therapy, to consider repeat ERCP. A bile sample should be collected for microbiological examination during repeat ERCP.Weak recommendation, low quality evidence., Competing Interests: T. Beyna receives consultancy fees from Olympus, Boston Scientific, and Cook (ongoing), and lecture fees from Olympus, Boston Scientific, and Medtronic (ongoing). M. Dinis-Ribeiro receives a fee as Co-Editor-in-Chief of Endoscopy journal. I. Hritz has provided consultancy and training for Olympus (2017 to present), and consultancy for Pentax Medical (2018). I. Papanikolaou has provided consultancy for Boston Scientific (25 April and 21 March, 2018). A. Tringali provided consultancy for Boston Scientific (3 April 2019); he has received publication fees from UpToDate. J.E. van Hooft has received lecture fees from Medtronics (2014 – 2015) and consultancy fees from Boston Scientific (2014 – 2017); her department has received research grants from Cook Medical (2014 – 2018) and Abbott (2014 – 2017). G. Vanbiervliet has provided consultancy to Boston Scientific (2016 to present) and Cook Medical (2019 to present). L. Aabakken, C. Kapral, J.M. Dumonceau, S. Lakhtakia, A. Mariani, G. Paspatis, F. Radaelli, and A. Veitch have no competing interests., (© Georg Thieme Verlag KG Stuttgart · New York.)
- Published
- 2020
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13. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019.
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Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellisé M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, and Dumonceau JM
- Subjects
- Administration, Oral, Antifoaming Agents administration & dosage, Dietary Fiber administration & dosage, Humans, Patient Education as Topic, Simethicone administration & dosage, Cathartics administration & dosage, Colonoscopy methods
- Abstract
ESGE recommends a low fiber diet on the day preceding colonoscopy.Strong recommendation, moderate quality evidence.ESGE recommends the use of enhanced instructions for bowel preparation.Strong recommendation, moderate quality evidence.ESGE suggests adding oral simethicone to bowel preparation.Weak recommendation, moderate quality evidence.ESGE recommends split-dose bowel preparation for elective colonoscopy.Strong recommendation, high quality evidence.ESGE recommends, for patients undergoing afternoon colonoscopy, a same-day bowel preparation as an acceptable alternative to split dosing.Strong recommendation, high quality evidence.ESGE recommends to start the last dose of bowel preparation within 5 hours of colonoscopy, and to complete it at least 2 hours before the beginning of the procedure.Strong recommendation, moderate quality evidence.ESGE recommends the use of high volume or low volume PEG-based regimens as well as that of non-PEG-based agents that have been clinically validated for routine bowel preparation. In patients at risk for hydroelectrolyte disturbances, the choice of laxative should be individualized.Strong recommendation, moderate quality evidence., Competing Interests: R. Benamouzig has provided consultancy to Alfasigma. R. Bisschops has received speaker’s fees from Norgine (1 January 2017 to present); he is Co-Editor of Endoscopy. E. Dekker is Co-Editor of Endoscopy. M. Dinis-Ribeiro is Co-Editor-in-Chief of Endoscopy. J. East received a speaker fee from Falk (January 2018); his department received support from Boston Scientific (March 2018 to March 2019). I. Gralnek declares consultancy, MAB, and share ownership in Motus GI (2014 to present). C. Hassan provides consultancy to Norgine; his department receives support from Alfasigma. R. Jover has received travel grants from Norgine (2015 to 2019); he has provided advisory services to Norgine (2015 to 2019), Alfasigma (2017 to 2018), GI Supply (2018 to 2019), and CPP Pharmaceuticals (2019); his department has received research grants from MSD (2010 to 2019). M.F. Kaminski has provided speaking and teaching services to Olympus, Alfasigma, and Norgine (2017 to present) and Fujinon (2018 to present), consultancy to Olympus (2017 to present), and advisory services to Alfasigma (2017 to present). M. Pellisé has received consultancy fees from Norgine Iberia (2012 to 2017, 2019 to present), and speaker’s fees from Casen Recordati (2018) and Olympus (2017); her department has been loaned equipment from Fujifilm (2017 to present); she is on the Endoscopy Board. F. Radaelli has received consultancy fees from Norgine (January 2018 to December 2018). C. Spada has received consultancy fees from Norgina and Alfasigma (2016 to 2019). J.E. van Hooft has received lecture fees from Medtronics (2014 to 2015) and Cook Medical (2019), and consultancy fees from Boston Scientific (2014 to 2017); her department has received research grants from Cook Medical (2014 to 2018) and Abbott (2014 to 2017). H. Awadie, M. Bretthauer, J.-M. Dumonceau, M. Ferlitsch, L. Frazzoni, L. Fuccio, C. Mangas-Sanjuan, K. Triantafyllou, and G. Vanella have no competing interests., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2019
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14. The paradox of the novel 1 L polyethylene glycol bowel preparation: efficacy, not tolerability, is the great new!
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Radaelli F
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- Bisacodyl, Colon, Laxatives, Cathartics, Polyethylene Glycols
- Abstract
Competing Interests: None., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2019
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15. Linked color imaging reduces the miss rate of neoplastic lesions in the right colon: a randomized tandem colonoscopy study.
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Paggi S, Mogavero G, Amato A, Rondonotti E, Andrealli A, Imperiali G, Lenoci N, Mandelli G, Terreni N, Conforti FS, Conte D, Spinzi G, and Radaelli F
- Subjects
- Aged, Color, Diagnostic Errors, Female, Humans, Male, Middle Aged, Prospective Studies, Adenoma diagnostic imaging, Colon, Ascending diagnostic imaging, Colon, Transverse diagnostic imaging, Colonic Neoplasms diagnostic imaging, Colonic Polyps diagnostic imaging, Colonoscopy, Image Enhancement methods
- Abstract
Background: Linked color imaging (LCI) is a newly developed image-enhancing endoscopy technology that provides bright endoscopic images and increases color contrast. We investigated whether LCI improves the detection of neoplastic lesions in the right colon when compared with high definition white-light imaging (WLI)., Methods: Consecutive patients undergoing colonoscopy were randomized (1:1) after cecal intubation into right colon inspection at first pass by LCI or by WLI. At the hepatic flexure, the scope was reintroduced to the cecum under LCI and a second right colon inspection was performed under WLI in previously LCI-scoped patients (LCI-WLI group) and vice versa (WLI-LCI group). Lesions detected on first- and second-pass examinations were used to calculate detection and miss rates, respectively. The primary outcome was the right colon adenoma miss rate., Results: Of the 600 patients enrolled, 142 had at least one adenoma in the right colon, with similar right colon adenoma detection rates (r-ADR) in the two groups (22.7 % in LCI-WLI and 24.7 % in WLI-LCI). At per-polyp analysis, double inspection of the right colon in the LCI-WLI and WLI-LCI groups resulted in an 11.8 % and 30.6 % adenoma miss rate, respectively ( P < 0.001). No significant difference in miss rate was found for advanced adenomas or sessile serrated lesions. At per-patient analysis, at least one adenoma was identified in the second pass only (incremental ADR) in 2 of 300 patients (0.7 %) in the LCI - WLI group and in 13 of 300 patients (4.3 %) in the WLI - LCI group ( P = 0.01)., Conclusions: LCI could reduce the miss rate of neoplastic lesions in the right colon., Competing Interests: None., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2018
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16. Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial.
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Cadoni S, Falt P, Rondonotti E, Radaelli F, Fojtik P, Gallittu P, Liggi M, Amato A, Paggi S, Smajstrla V, Urban O, Erriu M, Koo M, and Leung FW
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- Aged, Air, Cathartics administration & dosage, Colon, Ascending, Colon, Transverse, Double-Blind Method, Female, Humans, Insufflation, Male, Middle Aged, Therapeutic Irrigation methods, Water, Adenoma diagnostic imaging, Colonic Neoplasms diagnostic imaging, Colonoscopy methods, Early Detection of Cancer methods
- Abstract
Background and study aims Single-center studies, which were retrospective and/or involved unblinded colonoscopists, have suggested that water exchange, but not water immersion, compared with air insufflation significantly increases the adenoma detection rate (ADR), particularly in the proximal and right colon. Head-to-head comparison of the three techniques with ADR as primary outcome and blinded colonoscopists has not been reported to date. In a randomized controlled trial with blinded colonoscopists, we aimed to evaluate the impact of the three insertion techniques on ADR. Patients and methods A total of 1224 patients aged 50 - 70 years (672 males) and undergoing screening colonoscopy were randomized 1:1:1 to water exchange, water immersion, or air insufflation. Split-dose bowel preparation was adopted to optimize colon cleansing. After the cecum had been reached, a second colonoscopist who was blinded to the insertion technique performed the withdrawal. The primary outcome was overall ADR according to the three insertion techniques (water exchange, water immersion, and air insufflation). Secondary outcomes were other pertinent overall and right colon procedure-related measures. Results Baseline characteristics of the three groups were comparable. Compared with air insufflation, water exchange achieved a significantly higher overall ADR (49.3 %, 95 % confidence interval [CI] 44.3 % - 54.2 % vs. 40.4 % 95 %CI 35.6 % - 45.3 %; P = 0.03); water exchange showed comparable overall ADR vs. water immersion (43.4 %, 95 %CI 38.5 % - 48.3 %; P = 0.28). In the right colon, water exchange achieved a higher ADR than air insufflation (24.0 %, 95 %CI 20.0 % - 28.5 % vs. 16.9 %, 95 %CI 13.4 % - 20.9 %; P = 0.04) and a higher advanced ADR (6.1 %, 95 %CI 4.0 % - 9.0 % vs. 2.5 %, 95 %CI 1.2 % - 4.6 %; P = 0.03). Compared with air insufflation, the mean number of adenomas per procedure was significantly higher with water exchange ( P = 0.04). Water exchange achieved the highest cleanliness scores (overall and in the right colon). These variables were comparable between water immersion and air insufflation. Conclusions The design with blinded observers strengthens the validity of the observation that water exchange, but not water immersion, can achieve significantly higher adenoma detection than air insufflation. Based on this evidence, the use of water exchange should be encouraged.Trial registered at ClinicalTrials.gov (NCT02041507)., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2017
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17. Early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis: a randomized trial.
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Mariani A, Di Leo M, Giardullo N, Giussani A, Marini M, Buffoli F, Cipolletta L, Radaelli F, Ravelli P, Lombardi G, D'Onofrio V, Macchiarelli R, Iiritano E, Le Grazie M, Pantaleo G, and Testoni PA
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- Aged, Aged, 80 and over, Common Bile Duct, Early Termination of Clinical Trials, Female, Humans, Male, Middle Aged, Pancreatitis etiology, Postoperative Complications etiology, Prospective Studies, Protective Factors, Catheterization adverse effects, Cholangiopancreatography, Endoscopic Retrograde adverse effects, Pancreatitis prevention & control, Postoperative Complications prevention & control, Sphincterotomy, Endoscopic methods
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Background and Study Aim: Precut sphincterotomy is a technique usually employed for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography (ERCP) for the treatment of bile duct disease. It is a validated risk factor for post-ERCP pancreatitis (PEP), but it is not clear whether the risk is related to the technique itself or to the repeated biliary cannulation attempts preceding it. The primary aim of the study was to assess the incidence of PEP in early precut compared with the standard technique in patients with difficult biliary cannulation. Secondary aims were to compare complications and cannulation success., Patients and Methods: In this prospective, multicenter, randomized, clinical trial, patients who were referred for therapeutic biliary ERCP and difficult biliary cannulation were randomized to early precut (Group A) or repeated papillary cannulation attempts followed, in cases of failure, by late precut (Group B). PEP was defined as the onset of upper abdominal pain associated with an elevation in serum pancreatic enzymes of at least three times the normal level at more than 24 hours after the procedure. No rectal indomethacin or diclofenac was used for prevention of PEP., Results: A total of 375 patients were enrolled. PEP developed in 10 of the 185 patients (5.4 %) in Group A and 23 of the 190 (12.1 %) in Group B (odds ratio [OR] 0.35; 95 % confidence interval [CI] 0.16 - 0.78). The incidence of PEP was significantly lower in the early precut group (10/185, 5.4 %) than in the delayed precut subgroup (19/135 [14.1 %]; OR 0.42, 95 %CI 0.17 - 1.07). There were no differences in biliary cannulation success rates, bleeding, perforation, and cholangitis., Conclusions: In patients with difficult biliary cannulation, early precut is an effective technique and can significantly reduce the incidence of PEP. Repeated biliary cannulation attempts are a real risk factor for this complication., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2016
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18. 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.
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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
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- Administration, Oral, Europe, Humans, United Kingdom, Anticoagulants administration & dosage, Endoscopy, Gastrointestinal standards, Gastroenterology, Gastrointestinal Hemorrhage therapy, Platelet Aggregation Inhibitors administration & dosage, Societies, Medical
- Abstract
The risk of endoscopy in patients on antithrombotics depends on the risks of procedural haemorrhage vs. 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 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 hours 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 hours 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)., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2016
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19. 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.
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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
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- 2016
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20. Split dosing with a low-volume preparation is not inferior to split dosing with a high-volume preparation for bowel cleansing in patients with a history of colorectal resection: a randomized trial.
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Mussetto A, Frazzoni L, Paggi S, Dari S, Laterza L, Radaelli F, Hassan C, Triossi O, and Fuccio L
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- Administration, Oral, Aged, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Combinations, Female, Humans, Male, Middle Aged, Patient Satisfaction, Postoperative Period, Prospective Studies, Retrospective Studies, Single-Blind Method, Bisacodyl administration & dosage, Cathartics administration & dosage, Citric Acid administration & dosage, Colectomy, Colon drug effects, Colonoscopy methods, Polyethylene Glycols administration & dosage
- Abstract
Background and Study Aim: The study compared the efficacy of bowel cleansing using a low-volume mixed preparation (15 mg bisacodyl plus 2 L polyethylene glycol [PEG] solution) versus a standard high-volume preparation (4 L PEG) in patients with previous colorectal resection., Patients and Methods: A total of 120 patients with prior colorectal resection for cancer undergoing surveillance colonoscopy were randomized to receive either a split-dose low-volume (n = 60) or high-volume (n = 60) preparation for bowel cleansing. The quality of bowel preparation, rated according to a modified Ottawa Bowel Preparation scale (mOBPS), represented the primary outcome measure. Tolerability, safety, and lesion detection rates were secondary outcomes., Results: No significant difference was observed between the low-volume and high-volume preparations in achievement of adequate cleansing (i. e. mOBPS ≤ 4; low-volume vs. high-volume group, 85.0 % vs. 81.7 %, P = 0.624). The low-volume preparation showed a higher success rate for cleansing of the right colon (P = 0.025); better tolerability in terms of intake of the whole amount of the preparation (P < 0.001) was also observed. According to the logistic regression analysis, the only predictors of unsuccessful cleansing were previous left colectomy (P = 0.012) and a longer elapsed time since the intervention (P = 0.034). Lesion detection rates were comparable between the groups. No serious adverse events were reported., Conclusion: A low-volume preparation is not inferior to a high-volume preparation for adequate bowel cleansing in patients with prior colorectal resection for cancer. If larger, multicenter, prospective studies confirm our findings, a low-volume preparation will represent a more tolerable option for such patients., Trial Registration Number: ClinicalTrial.gov identifier NCT01887158., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2015
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21. Diagnosis and management of nonvariceal upper gastrointestinal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.
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Gralnek IM, Dumonceau JM, Kuipers EJ, Lanas A, Sanders DS, Kurien M, Rotondano G, Hucl T, Dinis-Ribeiro M, Marmo R, Racz I, Arezzo A, Hoffmann RT, Lesur G, de Franchis R, Aabakken L, Veitch A, Radaelli F, Salgueiro P, Cardoso R, Maia L, Zullo A, Cipolletta L, and Hassan C
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- Europe, Hemostasis, Endoscopic standards, Humans, Disease Management, Endoscopy, Gastrointestinal standards, Gastroenterology, Gastrointestinal Hemorrhage diagnosis, Gastrointestinal Hemorrhage therapy, Hemostasis, Endoscopic methods, Societies, Medical
- Abstract
This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). It addresses the diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH). Main Recommendations MR1. ESGE recommends immediate assessment of hemodynamic status in patients who present with acute upper gastrointestinal hemorrhage (UGIH), with prompt intravascular volume replacement initially using crystalloid fluids if hemodynamic instability exists (strong recommendation, moderate quality evidence). MR2. ESGE recommends a restrictive red blood cell transfusion strategy that aims for a target hemoglobin between 7 g/dL and 9 g/dL. A higher target hemoglobin should be considered in patients with significant co-morbidity (e. g., ischemic cardiovascular disease) (strong recommendation, moderate quality evidence). MR3. ESGE recommends the use of the Glasgow-Blatchford Score (GBS) for pre-endoscopy risk stratification. Outpatients determined to be at very low risk, based upon a GBS score of 0 - 1, do not require early endoscopy nor hospital admission. Discharged patients should be informed of the risk of recurrent bleeding and be advised to maintain contact with the discharging hospital (strong recommendation, moderate quality evidence). MR4. ESGE recommends initiating high dose intravenous proton pump inhibitors (PPI), intravenous bolus followed by continuous infusion (80 mg then 8 mg/hour), in patients presenting with acute UGIH awaiting upper endoscopy. However, PPI infusion should not delay the performance of early endoscopy (strong recommendation, high quality evidence). MR5. ESGE does not recommend the routine use of nasogastric or orogastric aspiration/lavage in patients presenting with acute UGIH (strong recommendation, moderate quality evidence). MR6. ESGE recommends intravenous erythromycin (single dose, 250 mg given 30 - 120 minutes prior to upper gastrointestinal [GI] endoscopy) in patients with clinically severe or ongoing active UGIH. In selected patients, pre-endoscopic infusion of erythromycin significantly improves endoscopic visualization, reduces the need for second-look endoscopy, decreases the number of units of blood transfused, and reduces duration of hospital stay (strong recommendation, high quality evidence). MR7. Following hemodynamic resuscitation, ESGE recommends early (≤ 24 hours) upper GI endoscopy. Very early (< 12 hours) upper GI endoscopy may be considered in patients with high risk clinical features, namely: hemodynamic instability (tachycardia, hypotension) that persists despite ongoing attempts at volume resuscitation; in-hospital bloody emesis/nasogastric aspirate; or contraindication to the interruption of anticoagulation (strong recommendation, moderate quality evidence). MR8. ESGE recommends that peptic ulcers with spurting or oozing bleeding (Forrest classification Ia and Ib, respectively) or with a nonbleeding visible vessel (Forrest classification IIa) receive endoscopic hemostasis because these lesions are at high risk for persistent bleeding or rebleeding (strong recommendation, high quality evidence). MR9. ESGE recommends that peptic ulcers with an adherent clot (Forrest classification IIb) be considered for endoscopic clot removal. Once the clot is removed, any identified underlying active bleeding (Forrest classification Ia or Ib) or nonbleeding visible vessel (Forrest classification IIa) should receive endoscopic hemostasis (weak recommendation, moderate quality evidence). MR10. In patients with peptic ulcers having a flat pigmented spot (Forrest classification IIc) or clean base (Forrest classification III), ESGE does not recommend endoscopic hemostasis as these stigmata present a low risk of recurrent bleeding. In selected clinical settings, these patients may be discharged to home on standard PPI therapy, e. g., oral PPI once-daily (strong recommendation, moderate quality evidence). MR11. ESGE recommends that epinephrine injection therapy not be used as endoscopic monotherapy. If used, it should be combined with a second endoscopic hemostasis modality (strong recommendation, high quality evidence). MR12. ESGE recommends PPI therapy for patients who receive endoscopic hemostasis and for patients with adherent clot not receiving endoscopic hemostasis. PPI therapy should be high dose and administered as an intravenous bolus followed by continuous infusion (80 mg then 8 mg/hour) for 72 hours post endoscopy (strong recommendation, high quality evidence). MR13. ESGE does not recommend routine second-look endoscopy as part of the management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH). However, in patients with clinical evidence of rebleeding following successful initial endoscopic hemostasis, ESGE recommends repeat upper endoscopy with hemostasis if indicated. In the case of failure of this second attempt at hemostasis, transcatheter angiographic embolization (TAE) or surgery should be considered (strong recommendation, high quality evidence). MR14. In patients with NVUGIH secondary to peptic ulcer, ESGE recommends investigating for the presence of Helicobacter pylori in the acute setting with initiation of appropriate antibiotic therapy when H. pylori is detected. Re-testing for H. pylori should be performed in those patients with a negative test in the acute setting. Documentation of successful H. pylori eradication is recommended (strong recommendation, high quality evidence). MR15. In patients receiving low dose aspirin for secondary cardiovascular prophylaxis who develop peptic ulcer bleeding, ESGE recommends aspirin be resumed immediately following index endoscopy if the risk of rebleeding is low (e. g., FIIc, FIII). In patients with high risk peptic ulcer (FIa, FIb, FIIa, FIIb), early reintroduction of aspirin by day 3 after index endoscopy is recommended, provided that adequate hemostasis has been established (strong recommendation, moderate quality evidence)., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2015
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22. Narrow-band imaging in the prediction of surveillance intervals after polypectomy in community practice.
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Paggi S, Rondonotti E, Amato A, Fuccio L, Andrealli A, Spinzi G, and Radaelli F
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- Adult, Aged, Colonic Polyps surgery, Diagnosis, Differential, Hospitals, Community, Humans, Middle Aged, Predictive Value of Tests, Prospective Studies, Time Factors, Adenoma diagnosis, Colonic Neoplasms diagnosis, Colonic Polyps diagnosis, Colonoscopy, Narrow Band Imaging, Population Surveillance
- Abstract
Background and Study Aims: It has been proposed that the use of narrow-band imaging (NBI) for real-time histological assessment to determine postpolypectomy surveillance intervals is a cost-effective approach to the management of diminutive polyps. However, significant discrepancies in NBI performance have been observed among endoscopists; hence, professional societies recommend training, monitoring, and auditing. The aim of the present study was to evaluate the performance of real-time optical diagnosis for diminutive polyps after the inclusion of this approach in an internal quality assurance program, in order to assess its applicability in clinical practice Patients and methods: Four endoscopists attended periodic training sessions on NBI assessment of polyp histology before and during the study. Performance was audited and periodic feedback was provided. The accuracy of high-confidence NBI evaluation for polyps ≤ 5 mm in predicting surveillance intervals according to the European and US guidelines, and the negative predictive value (NPV) for adenoma in the rectosigmoid were calculated and compared with recommended thresholds (90 % agreement and 90 % NPV, respectively)., Results: Overall, 284 outpatients (mean age 61.3 ± 18.2 years; 63 % males) were enrolled. A total of 656 polyps were detected, 465 of which (70.9 %) were diminutive (70.5 % adenomas). Sensitivity, specificity, positive and negative predictive values, and accuracy of high-confidence NBI predictions for adenoma in diminutive lesions were 95.3 %, 83.5 %, 93.5 %, 87.6 %, and 91.9 %, respectively. High-confidence characterization of diminutive polyps predicted the correct surveillance interval in 95.8 % and 93.3 % of cases according to European and American guidelines, respectively. NPV for adenoma in the rectosigmoid was 91.3 %, Conclusions: For community settings in which endoscopists are adequately trained and performance is periodically audited, real-time optical diagnosis for diminutive polyps is sufficiently accurate to avoid postpolypectomy histological examination of resected lesions, or to leave rectosigmoid hyperplastic polyps in place. Trial registered at ClinicalTrials.gov (NCT02196402)., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2015
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23. Endoscopic treatment of rectal pocket syndrome.
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Amato A, Vannelli A, Radaelli F, Paggi S, Rondonotti E, and Spinzi G
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- Aged, Diagnosis, Differential, Endosonography, Female, Humans, Magnetic Resonance Imaging, Rectal Diseases diagnosis, Rectum diagnostic imaging, Rectum pathology, Syndrome, Colonoscopy methods, Rectal Diseases surgery, Rectum surgery
- Published
- 2013
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24. Resect and discard strategy in clinical practice: a prospective cohort study.
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Paggi S, Rondonotti E, Amato A, Terruzzi V, Imperiali G, Mandelli G, Terreni N, Lenoci N, Spinzi G, and Radaelli F
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- Adenoma pathology, Colonic Polyps pathology, Diagnosis, Differential, Female, Hospitals, Community, Humans, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Sensitivity and Specificity, Adenoma diagnosis, Adenoma surgery, Colonic Polyps diagnosis, Colonic Polyps surgery, Colonoscopy, Image Enhancement methods
- Abstract
Background and Study Aims: Narrow-band imaging (NBI) has shown promising results in discriminating adenomatous from non-adenomatous colonic polyps. In patients with small polyps (< 10 mm), the application of NBI within a "resect and discard" strategy, might allow post-polypectomy surveillance intervals to be determined independently from histopathology. The aim of the present study was to assess the feasibility and safety of this approach in routine clinical practice., Patients and Methods: Consecutive colonoscopy outpatients with one or more polyps smaller than 10 mm were prospectively included. Each polyp was categorized by the endoscopist as adenoma or non-adenoma according to simplified NBI criteria, and future post-polypectomy surveillance interval was assigned accordingly. Following histopathology, post-polypectomy surveillance interval was subsequently re-assigned, and the accordance between endoscopy- and histology-directed surveillance strategies was calculated., Results: Among 942 colonoscopy patients, 286 (30.4 %) with only small polyps were included. In total, 511 small polyps were evaluated; 350 (68.5 %) were adenomas and 18 of these (5.1 %) had histologic features of advanced neoplasia. For the in vivo diagnosis of adenoma, NBI sensitivity, specificity, accuracy, and positive and negative likelihood ratios were 94.9 %, 65.8 %, 85.7 %, 2.80, and 0.08, respectively. The endoscopy-directed surveillance strategy was in accordance with the histology-directed strategy in 237 of 286 patients (82.9 %). In 9.8 % and 7.3 % patients, the endoscopy-directed approach would have resulted in early and delayed surveillance, respectively., Conclusions: The resect and discard strategy seems to be a viable, safe, and cost-effective approach for the management of patients with small polyps. However, caution in the application of the strategy should be advocated for patients with polyps 6 - 9 mm in size and those with right-sided lesions, due to their malignant potential. The study was registered on Clinicaltrials.gov (NCT01462123)., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2012
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25. Warm water infusion colonoscopy: a review and meta-analysis.
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Rabenstein T, Radaelli F, and Zolk O
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- Air, Cecum, Colonoscopy adverse effects, Humans, Insufflation adverse effects, Pain Management, Randomized Controlled Trials as Topic, Treatment Failure, Colonoscopy methods, Insufflation methods, Water
- Abstract
Background and Study Aims: Warm water infusion instead of traditional air insufflation during the insertion phase of colonoscopy has been proposed to reduce pain and improve patient acceptance of the procedure. This systematic review aimed to compare warm water infusion with standard air insufflation according to findings from randomized controlled trials (RCTs)., Methods: In a systematic review and meta-analysis of RCTs comparing warm water infusion with standard air insufflation, primary outcome measures were procedure-related (cecal intubation, time to cecal intubation, and adenoma detection rates) and patient-related (pain)., Results: Nine studies (1283 patients) were included. Warm water infusion, as sole modality for facilitating insertion, was associated with a fourfold higher risk of cecal intubation failure compared with air insufflation (risk ratio [RR] 4.01, confidence interval [CI] 1.17 to 13.78, P = 0.03), but this risk did not significantly differ between warm water infusion and air insufflation with the hybrid technique (i. e., brief use of air when difficulty, e. g. poor view, was encountered). Warm water infusion and air insufflation were associated with similar cecal intubation times (P = 0.62) and adenoma detection rates (P = 0.49), but with warm water infusion patients experienced significantly less pain (P < 0.00001) and a significantly lower proportion requested sedation and/or analgesia (RR 0.48, CI 0.35 to 0.66, P < 0.00001)., Conclusions: Although failure of cecal intubation is more frequent with warm water infusion, technical modifications, i. e., short air insufflations, can abolish this. Warm water infusion is less painful than standard air insufflation, reduces the need for sedation/analgesia, and improves patient acceptance of colonoscopy, without additional adverse reactions., (© Georg Thieme Verlag KG Stuttgart · New York.)
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- 2012
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26. The spectrum of small-bowel lesions of AL-type amyloidosis at capsule endoscopy.
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Mandelli G, Radaelli F, Amato A, Terreni N, Paggi S, Spinzi G, Ceretti E, and Terruzzi V
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- Abdominal Pain diagnosis, Abdominal Pain etiology, Amyloidosis pathology, Bence Jones Protein urine, Biopsy, Needle, Blood Chemical Analysis, Diagnosis, Differential, Echocardiography, Doppler, Electrocardiography, Emergency Service, Hospital, Endoscopy, Gastrointestinal methods, Gastrointestinal Diseases pathology, Humans, Immunohistochemistry, Intestinal Mucosa pathology, Male, Melena diagnosis, Melena etiology, Middle Aged, Severity of Illness Index, Amyloidosis diagnosis, Capsule Endoscopy methods, Gastrointestinal Diseases diagnosis, Intestine, Small, Myocardial Infarction diagnosis
- Published
- 2009
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27. Effectiveness of a continuous quality improvement program on colonoscopy practice.
- Author
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Imperiali G, Minoli G, Meucci GM, Spinzi G, Strocchi E, Terruzzi V, and Radaelli F
- Subjects
- Clinical Competence, Colonic Polyps diagnosis, Colonoscopy adverse effects, Conscious Sedation, Diagnostic Tests, Routine standards, Education, Medical, Continuing, Humans, Italy, Prospective Studies, Quality Indicators, Health Care, Colonoscopy standards, Total Quality Management
- Abstract
Background and Study Aim: Continuous quality improvement (CQI) is recommended by professional societies as part of every colonoscopy program, but little is known with regard to its effectiveness for colonoscopy outcomes. We prospectively assessed whether the implementation of a CQI program in routine clinical practice influences the quality performance of colonoscopy., Methods: In an open-access endoscopy unit at a secondary care center in Northern Italy, 6-monthly audit cycles were carried out over a 4-year period, to identify reasons for poor colonoscopy outcomes and institute appropriate changes to improve performance. The colonoscopy completion rate and the polyp detection rate as detected by endoscopists were considered to be key measures for improvement., Results: The initial crude colonoscopy completion rate was 84.6%, with a range for individual endoscopists 80.4%-94%. Four endoscopists had a completion rate lower than 90%. The overall polyp detection rate was 34%, with a wide variation among endoscopists (range 14%-42%). Poor patient tolerance and differences in colonoscopist expertise were the main determinants of lack of completion and variation in polyp detection rate. Changes to sedation practice, greater access to endoscopy sessions for the endoscopists with the lowest performance rates, and other organizational arrangements, were implemented to improve quality performance. The crude completion rates improved consistently, up to 93.1%, over the study period. This trend was confirmed even when adjusted completion rates were calculated. All endoscopists reached a crude completion rate of 90% or more and a polyp detection rate of over 20%. The introduction of CQI did not significantly change the overall incidence of procedure-related complications., Conclusions: The effectiveness of colonoscopy can be improved by implementing a CQI program in routine colonoscopy practice.
- Published
- 2007
- Full Text
- View/download PDF
28. Is the supine position as safe and effective as the prone position for endoscopic retrograde cholangiopancreatography? A prospective randomized study.
- Author
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Terruzzi V, Radaelli F, Meucci G, and Minoli G
- Subjects
- Adult, Aged, Aged, 80 and over, Biliary Tract Diseases diagnosis, Biliary Tract Diseases surgery, Female, Humans, Male, Middle Aged, Probability, Prospective Studies, Risk Assessment, Safety, Sensitivity and Specificity, Cholangiopancreatography, Endoscopic Retrograde methods, Prone Position, Supine Position
- Abstract
Background and Study Aims: Endoscopic retrograde cholangiopancreatography (ERCP) is usually performed with the patient lying in the prone position, on the assumption that this position is optimal for cannulation of the papilla and for obtaining good-quality radiographic images. The supine position, however, may be more comfortable for the patient and may facilitate airway management, and this study aimed to compare the two positions in terms of procedure outcome, safety, and patient tolerance., Patients and Methods: Consecutive patients who were undergoing ERCP were randomized to start the procedure in either the prone position or the supine position. Patients under the age of 18 years, intubated patients, and those who had already undergone endoscopic sphincterotomy were excluded. The difficulty of cannulation was assessed using the Freeman score (1=one to five attempts; 2=six to 15 attempts; 3=more than 15 attempts; 4=failure of cannulation). Total procedure time, patient tolerance, willingness to undergo ERCP in the future, and procedure-related adverse cardiorespiratory events (oxygen desaturation, tachycardia, bradycardia) were also recorded., Results: A total of 34 patients were evaluated (21 men, 13 women; mean age 68, range 20-96), 17 patients in each group. Demographic and clinical features, and the indications for the procedure were similar for the two patient groups. The median Freeman score was significantly lower in the prone group compared with the supine group (1 vs. 3, P=0.0047, rank sum test). Biliary cannulation was achieved in all patients in the prone group, but was not achieved in five patients (29%) in the supine group (P=0.052). In four of these five patients, biliary cannulation was successfully achieved after turning the patient into the prone position. The percentage of patients unwilling to repeat the ERCP procedure in the future was higher in the supine group (29% vs. 6%, P=0.087); the mean tolerance score and mean total procedure time were similar in the two groups. Seven patients in the supine group experienced at least one adverse cardiorespiratory event, compared with only one patient in the prone group (41% vs. 6%, P=0.039)., Conclusions: ERCP performed with the patient in the supine position is technically more demanding for operators used to working with patients in the prone position and carries a greater risk of adverse cardiorespiratory events in nonintubated patients.
- Published
- 2005
- Full Text
- View/download PDF
29. Increased prevalence of migraine in patients with uninvestigated dyspepsia referred for open-access upper gastrointestinal endoscopy.
- Author
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Meucci G, Radaelli F, Prada A, Bortoli A, Crotta S, Cerrato C, and Minoli G
- Subjects
- Adolescent, Adult, Dyspepsia complications, Female, Humans, Male, Middle Aged, Migraine Disorders complications, Prevalence, Dyspepsia etiology, Endoscopy, Digestive System, Gastrointestinal Diseases diagnosis, Migraine Disorders epidemiology
- Abstract
Background and Study Aims: The association between gastrointestinal symptoms and headache is frequently unrecognized. The aim of the present study was to determine the prevalence of migraine in dyspeptic outpatients referred for upper gastrointestinal endoscopy., Patients and Methods: Patients aged 18 - 55 years undergoing upper gastrointestinal endoscopy for dyspeptic symptoms in three endoscopic units were recruited consecutively. All of the patients were given a validated questionnaire on headache symptoms in order to determine the prevalence of migraine. Patients were divided into four groups (ulcer-like dyspepsia, reflux-like dyspepsia, dysmotility-like dyspepsia, only nausea and/or vomiting). Age-matched blood donors were given the same questionnaires and served as controls., Results: A total of 378 patients (mean age 40 +/- 11, 52 % men) and 310 controls (mean age 39 +/- 11, 56 % men) were enrolled. No differences were observed between the two groups in the prevalence of migraine (15 % vs. 11 %; P = 0.12). A higher prevalence of migraine was found among women in both groups (P < 0.006). In patients with reflux-like and ulcer-like dyspepsia, the prevalence of migraine did not differ from that in the control individuals (8 % and 7 %, respectively), whereas a higher prevalence of migraine was noted in patients with dysmotility-like dyspepsia (23 %; P < 0.02 vs. controls, those with ulcer-like dyspepsia and those with reflux-like dyspepsia) and in patients with nausea and/or vomiting alone (53 %; P < 0.002 vs. all other groups). The multivariate analysis confirmed that the symptom pattern and sex were the only variables independently associated with migraine., Conclusions: A diagnosis of migraine should be considered in young patients referred for upper gastrointestinal endoscopy due to nausea and/or vomiting or for dysmotility-like dyspepsia.
- Published
- 2005
- Full Text
- View/download PDF
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