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Background and study aims Artificial Intelligence (AI) systems could make the optical diagnosis (OD) of diminutive colorectal polyps (DCPs) more reliable and objective. This study was aimed at prospectively evaluating feasibility and diagnostic performance of AI-standalone and AI-assisted OD of DCPs in a real-life setting by using a white light-based system (GI Genius, Medtronic Co, Minneapolis, Minnesota, United States). Patients and methods Consecutive colonoscopy outpatients with at least one DCP were evaluated by 11 endoscopists (5 experts and 6 non-experts in OD). DCPs were classified in real time by AI (AI-standalone OD) and by the endoscopist with the assistance of AI (AI-assisted OD), with histopathology as the reference standard. Results Of the 480 DCPs, AI provided the outcome "adenoma" or "non-adenoma" in 81.4% (95% confidence interval [CI]: 77.5-84.6). Sensitivity, specificity, positive and negative predictive value, and accuracy of AI-standalone OD were 97.0% (95% CI 94.0-98.6), 38.1% (95% CI 28.9-48.1), 80.1% (95% CI 75.2-84.2), 83.3% (95% CI 69.2-92.0), and 80.5% (95% CI 68.7-82.8%), respectively. Compared with AI-standalone, the specificity of AI-assisted OD was significantly higher (58.9%, 95% CI 49.7-67.5) and a trend toward an increase was observed for other diagnostic performance measures. Overall accuracy and negative predictive value of AI-assisted OD for experts and non-experts were 85.8% (95% CI 80.0-90.4) vs. 80.1% (95% CI 73.6-85.6) and 89.1% (95% CI 75.6-95.9) vs. 80.0% (95% CI 63.9-90.4), respectively. Conclusions Standalone AI is able to provide an OD of adenoma/non-adenoma in more than 80% of DCPs, with a high sensitivity but low specificity. The human-machine interaction improved diagnostic performance, especially when experts were involved.
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Several scoring systems have been developed for both upper and lower GI bleeding to predict the bleeding severity and discriminate between low-risk patients, who may be suitable for outpatient management, and those who would likely need hospital-based interventions and are at high risk for adverse outcomes. Risk scores created to identify low-risk patients (namely the Glasgow Blatchford Score and the Oakland score) showed very good discriminative performances and their implementation has proven to be effective in reducing hospital admissions and healthcare burden. Conversely, the performances of risk scores in identifying specific adverse events to define high-risk patients are less accurate, and whether their integration into routine clinical practice has a tangible impact on patient management remains unproven. This review describes the existing risk score systems for GI bleeding, emphasizes key research findings, elucidates the circumstances in which their utilization can be beneficial, examines their constraints when considering routine clinical application, and discuss future development.
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Hemorragia Gastrointestinal , Hospitales , Humanos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/terapia , Factores de Riesgo , Pronóstico , Estudios RetrospectivosRESUMEN
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 (≤â5âmm) rectosigmoid polyps (DRSPs). METHODS: Consecutive colonoscopy outpatients with ≥â1 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 ≥â90â% 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 (≥â90â%; 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 92.3â%. The NPV of AI-assisted optical diagnosis for DRSPs (PIVI-1) was 91.0â% (95â%CI 87.1â%-93.9â%). The PIVI-2 threshold was met with 97.4â% (95â%CI 95.7â%-98.9â%) and 92.6â% (95â%CI 90.0â%-95.2â%) of patients according to ESGE and USMSTF, respectively. AI-assisted optical diagnosis accuracy was significantly lower for nonexperts (82.3â%, 95â%CI 76.4â%-87.3â%) than for experts (91.9â%, 95â%CI 88.5â%-94.5â%); 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.
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Adenoma , Pólipos del Colon , Neoplasias Colorrectales , Humanos , Inteligencia Artificial , Pólipos del Colon/diagnóstico por imagen , Pólipos del Colon/cirugía , Colonoscopía , Colon/patología , Adenoma/diagnóstico por imagen , Adenoma/cirugía , Imagen de Banda Estrecha , Neoplasias Colorrectales/diagnóstico por imagen , Neoplasias Colorrectales/cirugíaRESUMEN
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 ADRâ>â25â%. 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 (≤â40â%, 41â%-45â%,â≥â46â%) 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 53.6â% (95â%CI 48.6â%-58.5â%) vs. 45.3â% (95â%CI 40.3â%-50.45â%; RR 1.18; 95â%CI 1.03-1.36); APC 1.13 (SD 1.54) vs. 0.90 (SD 1.32; P â=â0.03). No significant difference in advanced-ADR was found (18.5â% [95â%CI 14.8â%-22.6â%] vs. 15.9â% [95â%CI 12.5â%-19.9â%], 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.
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Adenoma , Neoplasias Colorrectales , Masculino , Humanos , Persona de Mediana Edad , Detección Precoz del Cáncer , Colonoscopía , Neoplasias Colorrectales/diagnóstico , Adenoma/diagnóstico , Tamizaje MasivoRESUMEN
BACKGROUND & AIM: Although acute lower GI bleeding (LGIB) represents a significant healthcare burden, prospective real-life data on management and outcomes are scanty. Present multicentre, prospective cohort study was aimed at evaluating mortality and associated risk factors and at describing patient management. METHODS: Adult outpatients acutely admitted for or developing LGIB during hospitalization were consecutively enrolled in 15 high-volume referral centers. Demographics, comorbidities, medications, interventions and outcomes were recorded. RESULTS: Overall 1,198 patients (1060 new admissions;138 inpatients) were included. Most patients were elderly (mean-age 74±15 years), 31% had a Charlson-Comorbidity-Index ≥3, 58% were on antithrombotic therapy. In-hospital mortality (primary outcome) was 3.4% (95%CI 2.5-4.6). At logistic regression analysis, independent predictors of mortality were increasing age, comorbidity, inpatient status, hemodynamic instability at presentation, and ICU-admission. Colonoscopy had a 78.8% diagnostic yield, with significantly higher hemostasis rate when performed within 24-hours than later (21.3% vs.10.8%, pâ¯=â¯0.027). Endoscopic hemostasis was associated with neither in-hospital mortality nor rebleeding. A definite or presumptive source of bleeding was disclosed in 90.4% of investigated patients. CONCLUSION: Mortality in LGIB patients is mainly related to age and comorbidities. Although early colonoscopy has a relevant diagnostic yield and is associated with higher therapeutic intervention rate, endoscopic hemostasis is not associated with improved clinical outcomes [ClinicalTrial.gov number: NCT04364412].
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Hemorragia Gastrointestinal/mortalidad , Factores de Edad , Anciano , Anciano de 80 o más Años , Comorbilidad , Femenino , Hemorragia Gastrointestinal/etiología , Mortalidad Hospitalaria , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND AND AIMS: Since 2008, a plethora of research studies has compared the efficacy of water-assisted (aided) colonoscopy (WAC) and underwater resection (UWR) of colorectal lesions with standard colonoscopy. We reviewed and graded the research evidence with potential clinical application. We conducted a modified Delphi consensus among experienced colonoscopists on definitions and practice of water immersion (WI), water exchange (WE), and UWR. METHODS: Major databases were searched to obtain research reports that could potentially shape clinical practice related to WAC and UWR. Pertinent references were graded (Grading of Recommendations, Assessment, Development and Evaluation). Extracted data supporting evidence-based statements were tabulated and provided to respondents. We received responses from 55 (85% surveyed) experienced colonoscopists (37 experts and 18 nonexperts in WAC) from 16 countries in 3 rounds. Voting was conducted anonymously in the second and third round, with ≥80% agreement defined as consensus. We aimed to obtain consensus in all statements. RESULTS: In the first and the second modified Delphi rounds, 20 proposed statements were decreased to 14 and then 11 statements. After the third round, the combined responses from all respondents depicted the consensus in 11 statements (S): definitions of WI (S1) and WE (S2), procedural features (S3-S5), impact on bowel cleanliness (S6), adenoma detection (S7), pain score (S8), and UWR (S9-S11). CONCLUSIONS: The most important consensus statements are that WI and WE are not the same in implementation and outcomes. Because studies that could potentially shape clinical practice of WAC and UWR were chosen for review, this modified Delphi consensus supports recommendations for the use of WAC in clinical practice.
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Adenoma , Agua , Adenoma/diagnóstico , Adenoma/cirugía , Colonoscopía , Consenso , Técnica Delphi , HumanosRESUMEN
BACKGROUND AND AIMS: Linked-color imaging (LCI), a new image-enhancing technology emphasizing contrast in mucosal color, has been demonstrated to substantially reduce polyp miss rate as compared with standard white-light imaging (WLI) in tandem colonoscopy studies. Whether LCI increases adenoma detection rate (ADR) remains unclear. METHODS: Consecutive subjects undergoing screening colonoscopy after fecal immunochemical test (FIT) positivity were 1:1 randomized to undergo colonoscopy with LCI or WLI, both in high-definition systems. Insertion and withdrawal phases of each colonoscopy were carried out using the same assigned light. Experienced endoscopists from 7 Italian centers participated in the study. Randomization was stratified by gender, age, and screening round. The primary outcome measure was represented by ADR. RESULTS: Of 704 eligible subjects, 649 were included (48.9% men, mean age ± standard deviation, 60.8 ± 7.3 years) and randomized to LCI (n = 326) or WLI (n = 323) colonoscopy. The ADR was higher in the LCI group (51.8%) than in the WLI group (43.7%) (relative risk, 1.19; 95% confidence interval, 1.01-1.40). The proportions of patients with advanced adenomas and sessile serrated lesions were, respectively, 21.2% and 8.6% in the LCI arm and 18.9% and 5.9% in the WLI arm (not significant for both comparisons). At multivariate analysis, LCI was independently associated with ADR, along with male gender, increasing age, and adequate (Boston Bowel Preparation Scale score ≥6) bowel preparation. At per-polyp analysis, the mean ± standard deviation number of adenomas per colonoscopy was comparable in the LCI and WLI arms, whereas the corresponding figures for proximal adenomas was significantly higher in the LCI group (.72 ± 1.2 vs .55 ± 1.07, P = .05) CONCLUSIONS: In FIT-positive patients undergoing screening colonoscopy, the routine use of LCI significantly increased the ADR. (Clinical trial registration number: NCT03690297.).
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Adenoma , Neoplasias Colorrectales , Adenoma/diagnóstico por imagen , Anciano , Colonoscopía , Neoplasias Colorrectales/diagnóstico por imagen , Detección Precoz del Cáncer , Femenino , Humanos , Italia , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND & AIMS: Blue-light imaging (BLI) is a chromoendoscopy technique that uses direct (not filtered) emission of blue light with short wavelength (410 nm) to increase visibility of microvascular pattern and superficial mucosa. A BLI-based classification system for colorectal polyps (also called BLI Adenomas Serrated International Classification, BASIC) has been created and was validated using still images or short videos. We aimed to validate BASIC in a clinical practice setting, using thresholds recommended by the American Society for Gastrointestinal Endoscopy for the resect and discard strategy as the reference standard. METHODS: We studied 333 patients (mean age, 62.7±8.1 y; 176 men) who underwent screening colonoscopy from January through July 2019. Six endoscopists trained in BASIC participated in the study. All detected diminutive polyps were characterized by real-time BLI and categorized as adenoma or non-adenoma according to BASIC. All polyps were removed and evaluated by histopathology. The BLI-directed surveillance intervals (based on high-confidence characterization of polyps 5 mm or smaller and pathology feature for others) were compared with histology-directed surveillance intervals, according to United States Multi-society Task Force and European Society of Gastrointestinal Endoscopy recommendations. We calculated negative-predictive values of optical real-time analysis of diminutive rectosigmoid adenomas. RESULTS: When we applied BASIC, 748 polyps smaller than 5 mm were categorized with 89% accuracy (95% CI, 85.9%-90.6%). BLI-directed surveillance was correct for 90% of patients according to the United States Multi-society task force criteria (95% CI, 86%-93%) and for 96% of patients according to European Society of Gastrointestinal Endoscopy criteria (95% CI, 93%-97%). The negative-predictive value for 302 polyps smaller than 5 mm, located in the rectosigmoid colon and evaluated with high confidence, based on histologic features of adenomatous polyps, was 91% (95% CI, 85%-95%). CONCLUSIONS: Our analysis of data from 333 patients undergoing screen colonoscopies supports the validity of BASIC discriminating diminutive colorectal polyps with histologic features of adenomas from non-adenomas. This allows for the implementation of the resect and discard strategy based on BLI in clinical practice. ClinicalTrials.gov no: NCT03746171.
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Adenoma , Pólipos Adenomatosos , Pólipos del Colon , Neoplasias Colorrectales , Adenoma/diagnóstico , Adenoma/patología , Adenoma/cirugía , Pólipos Adenomatosos/patología , Colon/patología , Pólipos del Colon/diagnóstico , Pólipos del Colon/patología , Pólipos del Colon/cirugía , Colonoscopía , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/patología , Neoplasias Colorrectales/cirugía , Humanos , Masculino , Persona de Mediana EdadRESUMEN
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 2001â-â2008 (derivation cohort) and 2009â-â2013 (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 (26.6â%) and 55 (27.1â%) 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, 95â%CI 1.02â-â2.64), ≥â1 advanced adenoma at index colonoscopy (OR 1.90, 95â%CI 1.05â-â3.43), and ≥â1 adenoma at first surveillance colonoscopy (OR 2.06, 95â%CI 1.29â-â3.27) were independently predictive of metachronous colorectal neoplasms at second surveillance colonoscopy. For patients without such risk factors, diagnostic accuracy parameters were: 89.3â% (95â%CI 82.0â%-94.3â%) and 78.2â% (95â%CI 65.0â%-88.2â%) sensitivity, and 28.5â% (95â%CI 23.5â%-33.9â%) and 33.8â% (95â%CI 26.2â%-42.0â%) specificity in derivation and validation group, respectively. No cancer would be missed. CONCLUSIONS: Patients with prior left-sided colon cancer or ≥â1 advanced adenoma at index colonoscopy or ≥â1 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.
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Neoplasias del Colon , Neoplasias Colorrectales , Neoplasias Primarias Secundarias , Neoplasias del Colon/epidemiología , Colonoscopía , Humanos , Neoplasias Primarias Secundarias/epidemiología , Estudios Prospectivos , Estudios Retrospectivos , Factores de RiesgoRESUMEN
BACKGROUND & AIMS: Adenoma detection rate (ADR) is an important quality assurance measure for colonoscopy. Some studies suggest that narrow-band imaging (NBI) may be more effective at detecting adenomas than white-light endoscopy (WLE) when bowel preparation is optimal. We conducted a meta-analysis of data from individual patients in randomized controlled trials that compared the efficacy of NBI to WLE in detection of adenomas. METHODS: We searched MEDLINE, EMBASE, and Cochrane Library databases through April 2017 for randomized controlled trials that assessed detection of colon polyps by high-definition WLE vs NBI and from which data on individual patients were available. The primary outcome measure was ADR adjusted for bowel preparation quality. Multilevel regression models were used with patients nested within trials, and trial included as a random effect. RESULTS: We collected data from 11 trials, comprising 4491 patients and 6636 polyps detected. Adenomas were detected in 952 of 2251 (42.3%) participants examined by WLE vs 1011 of 2239 (45.2%) participants examined by NBI (unadjusted odds ratio [OR] for detection of adenoma by WLE vs NBI, 1.14; 95% CI, 1.01-1.29; P = .04). NBI outperformed WLE only when bowel preparation was best: adequate preparation OR, 1.07 (95% CI, 0.92-1.24; P = .38) vs best preparation OR, 1.30 (95% CI, 1.04-1.62; P = .02). Second-generation bright NBI had a better ADR than WLE (second-generation NBI OR, 1.28; 95% CI, 1.05-1.56; P = .02), whereas first-generation NBI did not. NBI detected more non-adenomatous polyps than WLE (OR, 1.24; 95% CI, 1.06-1.44; P = .008) and flat polyps than WLE (OR, 1.24; 95% CI, 1.02-1.51; P = .03). CONCLUSIONS: In a meta-analysis of data from individual patients in randomized controlled trials, we found NBI to have a higher ADR than WLE, and that this effect is greater when bowel preparation is optimal.
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Adenoma/diagnóstico por imagen , Colonoscopía/métodos , Neoplasias Colorrectales/diagnóstico por imagen , Imagen de Banda Estrecha/métodos , Adenoma/epidemiología , Catárticos/administración & dosificación , Colonoscopía/estadística & datos numéricos , Neoplasias Colorrectales/epidemiología , Humanos , Imagen de Banda Estrecha/estadística & datos numéricos , Garantía de la Calidad de Atención de Salud , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND AND AIMS: Blue-light imaging (BLI) is a new chromoendoscopy technique, potentially useful for differentiating neoplastic from nonneoplastic lesions. The present study was aimed at comparing BLI with high-definition white light (HDWL) in the real-time histology prediction of colon polyps <10 mm. METHODS: Consecutive outpatients undergoing colonoscopy with the ELUXEO 7000 endoscopy platform and 760 series video colonoscopes (Fujifilm Co, Tokyo, Japan) who had at least 1 polyp <10 mm were randomized to BLI or HDWL for polyp characterization. The accuracy of high-confidence real-time histology prediction (adenoma vs not adenoma) by either BLI or HDWL for polyps <10 mm (primary end-point) and diminutive (≤5 mm) polyps was calculated, along with sensitivity, specificity, and positive and negative predictive values, with histopathology as the reference standard. RESULTS: A total of 483 polyps were detected in 245 randomized patients (125 and 120 in the BLI and HDWL arms, respectively). A total of 358 were diminutive, and 283 were adenomas. Overall, 222 (85.7%) and 193 (86.1%) polyps were characterized with high confidence by BLI and HDWL, respectively (P = .887), with an overall accuracy of 92% and 84%, respectively (P = .011). The accuracy was significantly higher by BLI than HDWL, also for diminutive polyps (92% vs 83%; P = .008). When BLI was used, the negative predictive value for diminutive rectosigmoid polyps was 88%, and the post-polypectomy surveillance interval was correctly attributed in 85.7% and 93.7% of patients, respectively, according to U.S. and European guidelines. CONCLUSION: BLI was superior to HDWL for the real-time prediction of histology in polyps <10 mm. A BLI-dedicated classification might further improve the endoscopist performance. (Clinical trial registration number: NCT03274115.).
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Pólipos Adenomatosos/patología , Pólipos del Colon/patología , Colonoscopía/métodos , Neoplasias Colorrectales/patología , Imagen de Banda Estrecha/métodos , Pólipos Adenomatosos/diagnóstico , Anciano , Pólipos del Colon/diagnóstico , Neoplasias Colorrectales/diagnóstico , Femenino , Humanos , Pólipos Intestinales/diagnóstico , Pólipos Intestinales/patología , Masculino , Persona de Mediana Edad , Sensibilidad y Especificidad , Carga TumoralRESUMEN
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.
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Anticoagulantes/efectos adversos , Endoscopía Gastrointestinal/efectos adversos , Hemorragia Gastrointestinal/etiología , Seguridad del Paciente , Administración Oral , Anciano , Anticoagulantes/administración & dosificación , Estudios de Cohortes , Procedimientos Quirúrgicos Electivos , Endoscopía Gastrointestinal/métodos , Femenino , Estudios de Seguimiento , Hemorragia Gastrointestinal/fisiopatología , Humanos , Italia , Masculino , Persona de Mediana Edad , Atención Perioperativa/métodos , Estudios Prospectivos , Medición de Riesgo , Accidente Cerebrovascular/prevención & control , Tromboembolia/prevención & control , Factores de Tiempo , Resultado del Tratamiento , Privación de TratamientoRESUMEN
GOALS: To test the hypothesis that water exchange (WE) significantly increases adenoma detection rates (ADR) compared with water immersion (WI). BACKGROUND: Low ADR was linked to increased risk for interval colorectal cancers and related deaths. Two recent randomized controlled trials of head-to-head comparison of WE, WI, and traditional air insufflation (AI) each showed that WE achieved significantly higher ADR than AI, but not WI. The data were pooled from these 2 studies to test the above hypothesis. STUDY: Two trials (5 sites, 14 colonoscopists) that randomized 1875 patients 1:1:1 to AI, WI, or WE were pooled and analyzed with ADR as the primary outcome. RESULTS: The ADR of AI (39.5%) and WI (42.4%) were comparable, significantly lower than that of WE (49.6%) (vs. AI P=0.001; vs. WI P=0.033). WE insertion time was 3 minutes longer than that of AI (P<0.001). WE showed significantly higher detection rate (vs. AI) of the >10 mm advanced adenomas. Right colon combined advanced and sessile serrated ADR of AI (3.4%) and WI (5%) were comparable and were significantly lower than that of WE (8.5%) (vs. AI P<0.001; vs. WI P=0.039). CONCLUSIONS: Compared with AI and WI, the superior ADR of WE offsets the drawback of a significantly longer insertion time. For quality improvement focused on increasing adenoma detection, WE is preferred over WI. The hypothesis that WE could lower the risk of interval colorectal cancers and related deaths should be tested.
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Adenoma/diagnóstico , Neoplasias Colorrectales/diagnóstico , Colonoscopía/métodos , Femenino , Humanos , Insuflación , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Sensibilidad y EspecificidadRESUMEN
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 (22.7â% in LCI-WLI and 24.7â% in WLI-LCI). At per-polyp analysis, double inspection of the right colon in the LCI-WLI and WLI-LCI groups resulted in an 11.8â% and 30.6â% adenoma miss rate, respectively (Pâ<â0.001). 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 (0.7â%) in the LCI - WLI group and in 13 of 300 patients (4.3â%) in the WLI - LCI group (Pâ=â0.01). CONCLUSIONS: LCI could reduce the miss rate of neoplastic lesions in the right colon.
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Adenoma/diagnóstico por imagen , Colon Ascendente/diagnóstico por imagen , Colon Transverso/diagnóstico por imagen , Neoplasias del Colon/diagnóstico por imagen , Pólipos del Colon/diagnóstico por imagen , Colonoscopía , Aumento de la Imagen/métodos , Anciano , Color , Errores Diagnósticos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: A split-dose (SD) regimen is crucial for colonoscopy quality. Compliance with SD for early morning colonoscopy is generally poor. The present study evaluated whether pre-colonoscopy counselling, in addition to a dedicated leaflet, might increase SD uptake. METHODS: Consecutive 50-69-year-old patients undergoing screening colonoscopy before 10 a.m. were randomized to either receive written information only on bowel preparation (Written Group, WG) or written and oral instructions (Written and Oral Group, WaOG). The leaflet strongly encouraged SD adoption. The primary endpoint was the number of patients adopting SD in each group. The secondary endpoints were predictors of SD uptake, compliance with preparation schemes and cleansing adequacy. RESULTS: A total of 286 patients (143 WG, 143 WaOG) were enrolled (mean age 59.6 ± 6.1 years, men 49.3%). SD was adopted by 114 and 125 patients in the WG and WaOG, respectively (79.7% versus 87.4%, p = 0.079). No significant differences were observed for the proportion of patients with full compliance with preparation scheme (97.9% versus 97.2%, p = 0.99) and of procedures with adequate bowel cleansing (95.6% versus 95.1%, p = 0.77). At multivariate analysis, a > 1 h travel time to the endoscopy service was inversely correlated with SD uptake (odds ratio (OR) 0.30, 95% confidence interval (CI) 0.09-0.98). CONCLUSIONS: Our leaflet guaranteed satisfactory uptake of SD and excellent adherence to the preparation scheme for early morning colonoscopy. Its use might marginalize the need for additional oral instructions, particularly in open-access settings.
RESUMEN
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 50â-â70 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 (49.3â%, 95â% confidence interval [CI] 44.3â%â-â54.2â% vs. 40.4â% 95â%CI 35.6â%â-â45.3â%; P â=â0.03); water exchange showed comparable overall ADR vs. water immersion (43.4â%, 95â%CI 38.5â%â-â48.3â%; P â=â0.28). In the right colon, water exchange achieved a higher ADR than air insufflation (24.0â%, 95â%CI 20.0â%â-â28.5â% vs. 16.9â%, 95â%CI 13.4â%â-â20.9â%; P â=â0.04) and a higher advanced ADR (6.1â%, 95â%CI 4.0â%â-â9.0â% vs. 2.5â%, 95â%CI 1.2â%â-â4.6â%; Pâ=â0.03). Compared with air insufflation, the mean number of adenomas per procedure was significantly higher with water exchange (Pâ=â0.04). 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).
Asunto(s)
Adenoma/diagnóstico por imagen , Neoplasias del Colon/diagnóstico por imagen , Colonoscopía/métodos , Detección Precoz del Cáncer/métodos , Anciano , Aire , Catárticos/administración & dosificación , Colon Ascendente , Colon Transverso , Método Doble Ciego , Femenino , Humanos , Insuflación , Masculino , Persona de Mediana Edad , Irrigación Terapéutica/métodos , AguaRESUMEN
BACKGROUND: Rapid on-site evaluation (ROSE) improves the adequacy and accuracy of EUS-guided tissue acquisition, although it is not routinely widely available. Evidence suggested that core needles might overcome the absence of ROSE. The aim of this study was to evaluate the influence of ROSE on the adequacy and accuracy of EUS-guided tissue acquisition with core needles in patients with pancreatic solid lesions. METHODS: Patients who underwent EUS-guided tissue acquisition of pancreatic mass lesions were retrospectively identified at three tertiary referral centers and those performed with the core needle were included. Adequacy, defined as the rate of cases in which a tissue specimen for proper examination was achieved, with and without ROSE was the primary outcome measure. The diagnostic accuracy and tissue core acquisition were the secondary outcome measures. RESULTS: A total of 333 patients with pancreatic solid mass lesions were included in the study; 140 cases sampled with ROSE and 193 cases without ROSE. The adequacy was 92.1 % in the group sampled with ROSE and 88.1 % in the group without ROSE (p = 0.227). In the ROSE group sensitivity, specificity, and accuracy were 90.7, 100 and 92.1 %, respectively. In the group without ROSE, sensitivity, specificity, and accuracy were 87.2, 100, and 88.1 %, respectively. No difference for all these figures was observed between the two groups. The tissue core was available in 61.4 and 53.4 % of cases with and without ROSE, respectively (p = 0.143). CONCLUSION: In the absence of ROSE, EUS-based tissue acquisition with Core needle should be considered since it achieves comparable tissue sampling adequacy and accuracy.