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1.
Gastrointest Endosc ; 100(1): 55-63.e1, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38272280

RESUMEN

BACKGROUND AND AIMS: Efforts have been made to develop an endoscopic screening system incorporating serologic gastric cancer (GC) risk stratification (ABC classification) alongside annual population-based GC screening using barium. We conducted a randomized controlled trial (RCT) to compare GC detection rates between the Ba-Endo group, which underwent annual barium tests for primary screening followed by detailed endoscopic examinations, and the ABC-Endo group, where endoscopy intervals were determined based on individual gastric cancer risk in the ABC classification. METHODS: In total, 1206 individuals from Yurihonjo and Nikaho City, Akita Prefecture, were randomized through the minimization method using sex and age as allocation factors. The intervention study was conducted for both groups over 5 years. The Ba-Endo group received annual barium tests, and the ABC-Endo group underwent EGD at different intervals: group A, EGD only at entry; group B, EGD once every 3 years; group C, EGD once every 2 years; and group D, EGD every year. RESULTS: There were 24 detected GC lesions, with a GC detection rate of 1.9%. GC detection rates in the Ba-Endo and ABC-Endo groups were 2.0% and 1.8%, respectively, with no significant differences between groups (P = 1.0). However, the rate of GC cured by endoscopic resection alone was 41.6% in the Ba-Endo group and was significantly higher at 90.9% in the ABC-Endo group (P = .02). CONCLUSIONS: There were no differences between the Ba-Endo and ABC-Endo groups in GC detection rates. However, the rate of detected GCs that could be cured by endoscopic resection alone was significantly higher in the ABC-Endo group. (Clinical trial registration number: UMIN000005962.).


Asunto(s)
Detección Precoz del Cáncer , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/diagnóstico , Masculino , Femenino , Persona de Mediana Edad , Anciano , Detección Precoz del Cáncer/métodos , Medición de Riesgo , Gastroscopía/métodos , Sulfato de Bario , Medios de Contraste , Endoscopía Gastrointestinal/métodos
2.
Endoscopy ; 2024 Jun 10.
Artículo en Inglés | MEDLINE | ID: mdl-38857619

RESUMEN

BACKGROUND: Sessile serrated lesions (SSLs) are associated with an increased risk of colorectal cancer. Data on the prevalence of SSLs in Asia are limited. We performed this study to estimate the prevalence of SSLs in Asia and to explore endoscopic factors that are associated with SSL detection. METHODS: This is a post-hoc analysis of a multicenter randomized controlled trial from four Asian countries/regions that compared adenoma detection rates using linked-color imaging (LCI) and white-light imaging. Colonoscopies were performed in an average-risk population for screening, diagnostic examination, or polyp surveillance. Patients with SSLs were compared against those without SSLs to evaluate for possible predictors of SSL detection using Firth's logistic regression. RESULTS: 2898 participants (mean age 64.5 years) were included in the analysis. The estimated prevalence of SSLs was 4.0% (95%CI 3.4%-4.8%), with no sex or age group differences. On multivariable analysis, use of LCI (adjusted odds ratio [aOR] 1.63, 95%CI 1.10-2.41), experienced endoscopists (aOR 1.94, 95%CI 1.25-3.00), use of transparent cap (aOR 1.75, 95%CI 1.09-2.81), and longer withdrawal time (aOR 1.06, 95%CI 1.03-1.10) were independently associated with SSL detection. Synchronous adenoma detection (aOR 1.89, 95%CI 1.20-2.99) was also predictive of SSL detection. CONCLUSION: The prevalence of SSLs in Asia is 4.0%. Use of LCI or a transparent cap, greater endoscopist experience, and longer withdrawal time were all associated with increased SSL detection.

3.
Gastric Cancer ; 27(1): 36-48, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38006568

RESUMEN

BACKGROUND: Although the risk of gastric cancer can be stratified according to Helicobacter pylori (H. pylori) IgG antibody titer and pepsinogen levels (ABC classification), a population-based gastric cancer screening system combining serological tests and endoscopy has not been introduced. This study aimed to compare the total testing cost per participant between the ABC classification method and the existing protocol. METHODS: Using the minimization method with sex and age as allocation factors, 1206 participants were randomly assigned to the following two methods for a 5-year intervention: barium photofluorography as primary examination followed by detailed examination with upper gastrointestinal endoscopy (Ba-Endo) and risk-based upper gastrointestinal endoscopy by ABC classification (ABC-Endo). The primary endpoint was the total testing cost per participant over a 5-year period. The secondary endpoint was the expense required to detect one gastric cancer. RESULTS: The total testing cost per participant was 39,711 yen in Ba-Endo (604 participants) and 45,227 yen in ABC-Endo (602 participants), with the latter being significantly higher (p < 0.001). During the intervention period, gastric cancer was found in 11 and eight participants in Ba-Endo and ABC-Endo, respectively. The expenses required to detect one gastric cancer were 2,240,931 yen in Ba-Endo and 3,486,662 yen in ABC-Endo. CONCLUSIONS: The testing cost per participant turned out to be higher in the ABC-Endo group than in the Ba-Endo group. This superiority trial, based on the hypothesis that the cost of testing is lower for ABC-Endo than for Ba-Endo, was rejected.


Asunto(s)
Detección Precoz del Cáncer , Infecciones por Helicobacter , Helicobacter pylori , Neoplasias Gástricas , Humanos , Anticuerpos Antibacterianos , Bario , Detección Precoz del Cáncer/economía , Detección Precoz del Cáncer/métodos , Infecciones por Helicobacter/diagnóstico , Infecciones por Helicobacter/complicaciones , Inmunoglobulina G , Pepsinógeno A , Fotofluorografía/economía , Neoplasias Gástricas/diagnóstico por imagen , Endoscopía Gastrointestinal/economía
4.
Gastric Cancer ; 27(3): 539-547, 2024 05.
Artículo en Inglés | MEDLINE | ID: mdl-38240891

RESUMEN

BACKGROUNDS: Cycle-consistent generative adversarial network (CycleGAN) is a deep neural network model that performs image-to-image translations. We generated virtual indigo carmine (IC) chromoendoscopy images of gastric neoplasms using CycleGAN and compared their diagnostic performance with that of white light endoscopy (WLE). METHODS: WLE and IC images of 176 patients with gastric neoplasms who underwent endoscopic resection were obtained. We used 1,633 images (911 WLE and 722 IC) of 146 cases in the training dataset to develop virtual IC images using CycleGAN. The remaining 30 WLE images were translated into 30 virtual IC images using the trained CycleGAN and used for validation. The lesion borders were evaluated by 118 endoscopists from 22 institutions using the 60 paired virtual IC and WLE images. The lesion area concordance rate and successful whole-lesion diagnosis were compared. RESULTS: The lesion area concordance rate based on the pathological diagnosis in virtual IC was lower than in WLE (44.1% vs. 48.5%, p < 0.01). The successful whole-lesion diagnosis was higher in the virtual IC than in WLE images; however, the difference was insignificant (28.2% vs. 26.4%, p = 0.11). Conversely, subgroup analyses revealed a significantly higher diagnosis in virtual IC than in WLE for depressed morphology (41.9% vs. 36.9%, p = 0.02), differentiated histology (27.6% vs. 24.8%, p = 0.02), smaller lesion size (42.3% vs. 38.3%, p = 0.01), and assessed by expert endoscopists (27.3% vs. 23.6%, p = 0.03). CONCLUSIONS: The diagnostic ability of virtual IC was higher for some lesions, but not completely superior to that of WLE. Adjustments are required to improve the imaging system's performance.


Asunto(s)
Aprendizaje Profundo , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/diagnóstico por imagen , Neoplasias Gástricas/cirugía , Endoscopía/métodos , Carmin de Índigo
5.
Gastric Cancer ; 2024 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-38937306

RESUMEN

BACKGROUND: The effectiveness of esophagogastroduodenoscopy (EGD) screening in cohorts with low Helicobacter pylori prevalence is unknown. This study aimed to develop an optimally efficient EGD screening strategy for detecting H. pylori-naïve gastric neoplasms (HpNGNs). METHODS: EGD data of 12 institutions from 2016 to 2022 were retrospectively analyzed. Age-related HpNGN prevalence, tumor growth rate, missing rate, and detection threshold size were calculated from the databases. Subsequently, using clinical data, a novel mathematical model that simultaneously simulated demographic changes and HpNGN detection was developed. Screening strategies using different starting ages (40/45/50 years) and intervals (2/5/10 years) were also compared. The detection rates of all tumors occurring within the virtual cohort and number-needed-to-test (NNT) were measured as outcomes. RESULTS: Data of 519,368 EGDs and 97 HpNGNs (34 pure signet ring cell carcinomas, 26 gastric adenocarcinomas of the fundic gland type, 30 foveolar gastric adenoma-Raspberry type, and seven undifferentiated-type cancer cases) were analyzed. A virtual cohort with a 70-year time horizon was used to simulate the occurrence, growth, and detection of 346,5836 people. Among the strategies with detection rate > 50%, the screening strategy with a 5-year interval starting at 45 years of age had the lowest NNT. Adopting this strategy, most HpNGNs were detected at < 20 mm in size, and the deep submucosal invasion rate was less than 30%. CONCLUSIONS: A mathematical simulation model revealed that screening every 5 years starting at 45 years of age could efficiently assist in identifying HpNGNs at an early stage.

6.
Artículo en Inglés | MEDLINE | ID: mdl-38348570

RESUMEN

BACKGROUND AND AIM: Regular endoscopy or fecal immunochemical test (FIT) is ideal for screening colorectal cancer. However, only a limited number of individuals undergo regular screening. This study aimed to compare the cost-effectiveness of a single colonoscopy with a single FIT performed for colorectal cancer screening. METHODS: A microsimulation model was constructed based on real-world observational data collected from three institutions between 2019 and 2022 that compared colonoscopy-based screening with FIT-based screening. The total costs of diagnosis and treatment of the detected lesions using the two strategies were calculated. The incremental cost-effectiveness ratio (ICER) per life year gained (LYG) of the colonoscopy-based strategy was calculated. RESULTS: Data from 11 407 patients undergoing colonoscopies and 59 176 patients undergoing FITs were used to establish a model. In the base case analysis of screening strategies, colonoscopy was more cost-effective than FIT (ICER 415 193 yen/LYG). The ICER of the colonoscopy-based strategy among 60- to 69-year-old patients was lowest at 394 200 yen/LYG, whereas that in 20- to 29-year-old patients was highest. Monte Carlo simulations showed that the colonoscopy-based strategy was more cost-effective than the FIT-based strategy (net monetary benefit [NMB]: 5 695 957 yen vs 5 348 253 yen). When the adenoma detection rate in the colonoscopy was over 30% or the positive FIT rate was lower than 8.6% in the FIT-based strategy, the NMB of the colonoscopy-based strategy exceeded that of the FIT-based strategy. CONCLUSION: In the microsimulation model, colonoscopy is recommended as a one-time screening procedure in patients aged >60 years with >30% ADR or <8.6% positive FIT rate.

7.
Artículo en Inglés | MEDLINE | ID: mdl-38602345

RESUMEN

BACKGROUND AND AIM: Linked color imaging (LCI) is an image-enhanced endoscopy technique that accentuates the color difference between red and white, potentially improving the adenoma detection rate (ADR). However, it remains unclear whether LCI performance in detecting colorectal lesions differs based on endoscopists' experience levels. We aimed to evaluate the differences in LCI efficacy based on the experience levels of endoscopists by conducting an exploratory analysis. METHODS: In this post hoc analysis of an international randomized controlled trial comparing the detection of adenoma and other lesions using colonoscopy with LCI and high-definition white light imaging (WLI), we included patients from 11 institutions across four countries/regions: Japan, Thailand, Taiwan, and Singapore. We retrospectively reviewed differences in the lesion detection of LCI according to endoscopists' colonoscopy history or ADR. RESULTS: We included 1692 and 1138 patients who underwent colonoscopies performed by 54 experts (experience of ≥ 5000 colonoscopies) and by 43 non-experts (experience of < 5000 colonoscopies), respectively. Both expert and non-expert groups showed a significant improvement in ADR with LCI compared to WLI (expert, 61.7% vs 46.4%; P < 0.001; non-expert, 56.6% vs 46.4%; P < 0.001). LCI had no effect on sessile serrated lesion detection rate in non-experts (3.1% vs 2.5%; P = 0.518). LCI significantly improved detection rates in endoscopists with relatively low detection performance, defined as an ADR < 50%. CONCLUSIONS: This exploratory study analyzed data from a previous trial and revealed that LCI is useful for both experts and non-experts and is even more beneficial for endoscopists with relatively low detection performance using WLI.

8.
Digestion ; : 1-11, 2024 Apr 18.
Artículo en Inglés | MEDLINE | ID: mdl-38631318

RESUMEN

INTRODUCTION: We investigated coexisting lesion types in patients with invasive colorectal cancer (CRC) in a multinational study for comprehending the adenoma-carcinoma and serrated pathway about the development of CRC. METHODS: We retrospectively reviewed 3,050 patients enrolled in the international randomized controlled trial (ATLAS study) to evaluate the colorectal polyp detection performance of image-enhanced endoscopy in 11 institutions in four Asian countries/regions. In the current study, as a subgroup analysis of the ATLAS study, 92 CRC patients were extracted and compared to 2,958 patients without CRC to examine the effects of age, sex, and coexisting lesion types (high-grade adenoma [HGA], low-grade adenoma with villous component [LGAV], 10 adenomas, adenoma ≥10 mm, sessile serrated lesions [SSLs], and SSLs with dysplasia [SSLD]). Additional analyses of coexisting lesion types were performed according to sex and location of CRC (right- or left-sided). RESULTS: A multivariate analysis showed that HGA (odds ratio [95% confidence interval] 4.29 [2.16-8.18]; p < 0.01), LGAV (3.02 [1.16-7.83], p = 0.02), and age (1.04 [1.01-1.06], p = 0.01) were independently associated with CRC. According to sex, the coexisting lesion types significantly associated with CRC were LGAV (5.58 [1.94-16.0], p < 0.01) and HGA (4.46 [1.95-10.20], p < 0.01) in males and HGA (4.82 [1.47-15.80], p < 0.01) in females. Regarding the location of CRC, SSLD (21.9 [1.31-365.0], p = 0.03) was significant for right-sided CRC, and HGA (5.22 [2.39-11.4], p < 0.01) and LGAV (3.46 [1.13-10.6], p = 0.02) were significant for left-sided CRC. CONCLUSIONS: The significant coexisting lesions in CRC differed according to sex and location. These findings may contribute to comprehending the pathogenesis of CRC.

9.
J Appl Toxicol ; 44(3): 415-427, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-37846211

RESUMEN

The hazards and potency of skin sensitizers are traditionally determined using animal tests such as the local lymph node assay (LLNA); however, significant progress has been made in the development of non-animal test methods addressing the first three mechanistic key events of adverse outcome pathway in skin sensitization. We developed the epidermal sensitization assay (EpiSensA), which is a reconstructed human epidermis-based assay, by measuring four genes related to critical keratinocyte responses during skin sensitization. Four in vitro skin sensitization test methods (EpiSensA, direct peptide reactivity assay [DPRA], KeratinoSens™, and human cell line activation test [h-CLAT]) were systematically evaluated using 136 chemicals including lipophilic chemicals and pre/pro-haptens, which may be related to assay-specific limitations. The constructed database included existing and newly generated data. The EpiSensA showed a broader applicability domain and predicted the hazards with 82.4% and 78.8% accuracy than LLNA and human data. The EpiSensA could detect 76 out of 88 sensitizers at lower concentrations than the LLNA, indicating that the EpiSensA has higher sensitivity for the detection of minor sensitizing constituents. These results confirmed the potential use of the EpiSensA in evaluating a mixture of unknown compositions that can be evaluated by animal tests. To combine different information sources, the reconstructed human epidermis-based testing strategy (RTS) was developed based on weighted multiple information from the EpiSensA and TImes MEtabolism Simulator platform for predicting Skin Sensitization (TIMES-SS; RTSv1) or Organization for Economic Cooperation and Development (OECD) QSAR Toolbox automated workflow (RTSv2). The predictivities of the hazards and Globally Harmonized System (GHS) subcategories were equal to or better than the defined approaches (2 out of 3, integrated testing strategy [ITS]v1, and ITSv2) adopted as OECD Guideline 497.


Asunto(s)
Alternativas a las Pruebas en Animales , Dermatitis Alérgica por Contacto , Animales , Humanos , Alternativas a las Pruebas en Animales/métodos , Piel , Epidermis , Queratinocitos/metabolismo , Pruebas Cutáneas , Ensayo del Nódulo Linfático Local , Dermatitis Alérgica por Contacto/etiología , Dermatitis Alérgica por Contacto/metabolismo
10.
J Appl Toxicol ; 44(4): 510-525, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37897225

RESUMEN

The Epidermal Sensitization Assay (EpiSensA) is a reconstructed human epidermis (RhE)-based gene expression assay for predicting the skin sensitization potential of chemicals. Since the RhE model is covered by a stratified stratum corneum, various kinds of test chemicals, including lipophilic ones and pre-/pro-haptens, can be tested with a route of exposure akin to an in vivo assay and human exposure. This article presents the results of a formally managed validation study of the EpiSensA that was carried out by three participating laboratories. The purpose of this validation study was to assess transferability of the EpiSensA to new laboratories along with its within- (WLR) and between-laboratory reproducibility (BLR). The validation study was organized into two independent stages. As demonstrated during the first stage, where three sensitizers and one non-sensitizer were correctly predicted by all participating laboratories, the EpiSensA was successfully transferred to all three participating laboratories. For Phase I of the second stage, each participating laboratory performed three experiments with an identical set of 15 coded test chemicals resulting in WLR of 93.3%, 93.3%, and 86.7%, respectively. Furthermore, when the results from the 15 test chemicals were combined with those of the additional 12 chemicals tested in Phase II of the second stage, the BLR for 27 test chemicals was 88.9%. Moreover, the predictive capacity among the three laboratories showed 92.6% sensitivity, 63.0% specificity, 82.7% accuracy, and 77.8% balanced accuracy based on murine local lymph node assay (LLNA) results. Overall, this validation study concluded that EpiSensA is easily transferable and sufficiently robust for assessing the skin sensitization potential of chemicals.


Asunto(s)
Alérgenos , Dermatitis Alérgica por Contacto , Humanos , Animales , Ratones , Reproducibilidad de los Resultados , Alérgenos/toxicidad , Epidermis , Piel , Haptenos/toxicidad , Ensayo del Nódulo Linfático Local , Alternativas a las Pruebas en Animales
11.
J Reconstr Microsurg ; 40(2): 102-108, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37142252

RESUMEN

BACKGROUND: The transverse cervical artery is less commonly used than other external carotid arteries as a recipient vessel. Therefore, we aimed to compare the utility of the transverse cervical artery as a recipient vessel with that of the external carotid artery system for microvascular head and neck reconstruction by quantitative analysis of dynamic-enhanced computed tomography. METHODS: Fifty-one consecutive patients who underwent free jejunum transfer following total pharyngolaryngectomy between January 2017 and December 2020 were retrospectively reviewed. Ninety-four pairs of the diameters of the transverse cervical artery, superior thyroid artery, and lingual artery, measured via computed tomography angiography, were analyzed. Operative outcomes were compared between the following groups based on the recipient artery: transverse cervical artery (n = 27), superior thyroid artery (n = 17), and other artery (n = 7) groups. RESULTS: In the analysis of the computed tomography angiography, nine transverse cervical arteries (9.6%) could not be identified. However, the percentage was significantly lower than the percentage of superior thyroid arteries (20.2%) and lingual arteries (18.1%) (p < 0.01). Among the identified vessels, the transverse cervical arteries (2.09 ± 0.41 mm) and the lingual arteries (1.97 ± 0.40 mm) were significantly larger than the superior thyroid arteries (1.70 ± 0.36 mm) in diameter at the commonly used level (p < 0.01). Multivariate analysis revealed that prior radiation therapy was not an independent factor significantly affecting transverse cervical artery diameter (p = 0.17). Intraoperative anastomotic revision was required in only two cases of the superior thyroid artery. CONCLUSION: The transverse cervical artery can offer a larger caliber and more reliable candidate than the superior thyroid artery for a recipient artery. More liberal use of the transverse cervical artery may improve the safety of microsurgical head and neck reconstruction.


Asunto(s)
Neoplasias de Cabeza y Cuello , Procedimientos de Cirugía Plástica , Humanos , Estudios Retrospectivos , Neoplasias de Cabeza y Cuello/cirugía , Angiografía por Tomografía Computarizada , Yeyuno , Cuello/cirugía , Arterias/cirugía
12.
Clin Gastroenterol Hepatol ; 21(6): 1493-1502.e4, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36328306

RESUMEN

BACKGROUND & AIMS: Effects of linked-color imaging (LCI) on colorectal lesion detection and colonoscopy quality remain controversial. This study compared the detection rates of adenoma and other precursor lesions using LCI vs white-light imaging (WLI) during screening, diagnostic, and surveillance colonoscopies. METHODS: This randomized controlled trial was performed at 11 institutions in 4 Asian countries/regions. Patients with abdominal symptoms, a primary screening colonoscopy, positive fecal immunochemical test results, or undergoing postpolypectomy surveillance were recruited and randomly assigned in a 1:1 ratio to either the LCI or high-definition WLI group. The primary outcome was adenoma detection rate (ADR). Secondary outcomes were polyp detection rate, advanced ADR, sessile serrated lesion (SSL) detection rate, and the mean number of adenomas per colonoscopy. The recommended surveillance schedule distribution after trial colonoscopy was analyzed. RESULTS: Between November 2020 and January 2022, there were 3050 participants (LCI, n = 1527; WLI, n = 1523) recruited. The LCI group ADR was significantly higher than the WLI group ADR using intention-to-treat (58.7% vs 46.7%; P < .01) and per-protocol analyses (59.6% vs 46.4%; P < .01). The LCI group polyp detection rates (68.6% vs 59.5%; P < .01), SSL detection rates (4.8% vs 2.8%; P < .01), and adenomas per colonoscopy (1.48 vs 1.02; P < .01) also were significantly higher. However, the advanced ADR was not significantly different (13.2% vs 11.0%; P = .06). Significantly more patients in the LCI group had shorter recommended surveillance schedules than the WLI group (P < .01). CONCLUSIONS: Compared with WLI, LCI improved adenoma and other polyp detection rates, including SSLs, resulting in alteration of the recommended surveillance schedule after screening, diagnostic, and postpolypectomy surveillance colonoscopies. TRIAL REGISTRATION NUMBER: UMIN000042432 (https://www.umin.ac.jp/ctr/index.htm).


Asunto(s)
Adenoma , Pólipos del Colon , Neoplasias Colorrectales , Pólipos , Humanos , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/patología , Colonoscopía/métodos , Adenoma/diagnóstico , Adenoma/patología , Pólipos/diagnóstico , Diagnóstico por Imagen , Pólipos del Colon/diagnóstico
13.
Clin Gastroenterol Hepatol ; 21(13): 3258-3269.e6, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37276989

RESUMEN

BACKGROUND & AIMS: Currently, large, nationwide, long-term follow-up data on acute lower gastrointestinal bleeding (ALGIB) are scarce. We investigated long-term risks of recurrence after hospital discharge for ALGIB using a large multicenter dataset. METHODS: We retrospectively analyzed 5048 patients who were urgently hospitalized for ALGIB at 49 hospitals across Japan (CODE BLUE-J study). Risk factors for the long-term recurrence of ALGIB were analyzed by using competing risk analysis, treating death without rebleeding as a competing risk. RESULTS: Rebleeding occurred in 1304 patients (25.8%) during a mean follow-up period of 31 months. The cumulative incidences of rebleeding at 1 and 5 years were 15.1% and 25.1%, respectively. The mortality risk was significantly higher in patients with out-of-hospital rebleeding episodes than in those without (hazard ratio, 1.42). Of the 30 factors, multivariate analysis showed that shock index ≥1 (subdistribution hazard ratio [SHR], 1.25), blood transfusion (SHR, 1.26), in-hospital rebleeding (SHR, 1.26), colonic diverticular bleeding (SHR, 2.38), and thienopyridine use (SHR, 1.24) were significantly associated with increased rebleeding risk. Multivariate analysis of colonic diverticular bleeding patients showed that blood transfusion (SHR, 1.20), in-hospital rebleeding (SHR, 1.30), and thienopyridine use (SHR, 1.32) were significantly associated with increased rebleeding risk, whereas endoscopic hemostasis (SHR, 0.83) significantly decreased the risk. CONCLUSIONS: These large, nationwide follow-up data highlighted the importance of endoscopic diagnosis and treatment during hospitalization and the assessment of the need for ongoing thienopyridine use to reduce the risk of out-of-hospital rebleeding. This information also aids in the identification of patients at high risk of rebleeding.


Asunto(s)
Enfermedades Diverticulares , Hemostasis Endoscópica , Humanos , Alta del Paciente , Estudios de Cohortes , Estudios Retrospectivos , Hemorragia Gastrointestinal/epidemiología , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/diagnóstico , Enfermedad Aguda , Factores de Riesgo , Hospitales , Tienopiridinas , Recurrencia
14.
Gastrointest Endosc ; 2023 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-38042206

RESUMEN

BACKGROUND AND AIMS: Pharmacokinetic parameters, such as drug plasma level at trough, time to maximum plasma concentration (Tmax), and coagulation factor Xa (FXa) activity generally predict factors for the anticoagulant effects of direct oral anticoagulants (DOACs). Although GI bleeding is a major adverse event after endoscopic submucosal dissection (ESD), little is known about the association between post-ESD bleeding in patients taking DOACs and the pharmacologic parameters. This study aimed to evaluate pharmacologic risk factors for post-ESD bleeding in patients taking DOACs. METHODS: We prospectively evaluated the incidence of post-ESD bleeding in patients taking DOACs between April 2018 and May 2022 at 21 Japanese institutions and investigated the association with post-ESD bleeding and pharmacologic factors, including plasma concentration and FXa activity at trough and Tmax. RESULTS: The incidence of post-ESD bleeding was 12.8% (14 of 109; 95% confidence interval [CI], 7.2-20.6). Although plasma DOAC concentration and plasma level/dose ratio at trough and Tmax varied widely among individuals, a significant correlation with plasma concentration and FXa activity was observed (apixaban: correlation coefficient, -0.893; P < .001). On multivariate analysis, risk factors for post-ESD bleeding in patients taking DOACs were higher age (odds ratio [OR], 1.192; 95% CI, 1.020-1.392; P = .027) and high anticoagulant ability analyzed by FXa activity at trough and Tmax (OR, 6.056; 95% CI, 1.094-33.529; P = .039). CONCLUSIONS: The incidence of post-ESD bleeding in patients taking DOACs was high, especially in older patients and with high anticoagulant effects of DOACs. Measurement of pharmacokinetic parameters of DOACs may be useful in identifying patients at higher risk of post-ESD bleeding.

15.
Gastrointest Endosc ; 98(1): 59-72.e7, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-36801460

RESUMEN

BACKGROUND AND AIMS: Ligation therapy, including endoscopic detachable snare ligation (EDSL) and endoscopic band ligation (EBL), has emerged as an endoscopic treatment for colonic diverticular bleeding (CDB); its comparative effectiveness and risk of recurrent bleeding remain unclear, however. Our goal was to compare the outcomes of EDSL and EBL in treating CDB and identify risk factors for recurrent bleeding after ligation therapy. METHODS: We reviewed data of 518 patients with CDB who underwent EDSL (n = 77) or EBL (n = 441) in a multicenter cohort study named the Colonic Diverticular Bleeding Leaders Update Evidence From Multicenter Japanese Study (CODE BLUE-J Study). Outcomes were compared by using propensity score matching. Logistic and Cox regression analyses were performed for recurrent bleeding risk, and a competing risk analysis was used to treat death without recurrent bleeding as a competing risk. RESULTS: No significant differences were found between the 2 groups in terms of initial hemostasis, 30-day recurrent bleeding, interventional radiology or surgery requirements, 30-day mortality, blood transfusion volume, length of hospital stay, and adverse events. Sigmoid colon involvement was an independent risk factor for 30-day recurrent bleeding (odds ratio, 1.87; 95% confidence interval, 1.02-3.40; P = .042). History of acute lower GI bleeding (ALGIB) was a significant long-term recurrent bleeding risk factor on Cox regression analysis. A performance status score of 3/4 and history of ALGIB were long-term recurrent bleeding factors on competing risk regression analysis. CONCLUSIONS: There were no significant differences in outcomes between EDSL and EBL for CDB. After ligation therapy, careful follow-up is required, especially in the treatment of sigmoid diverticular bleeding during admission. History of ALGIB and performance status at admission are important risk factors for long-term recurrent bleeding after discharge.


Asunto(s)
Enfermedades Diverticulares , Divertículo del Colon , Hemostasis Endoscópica , Humanos , Estudios de Cohortes , Enfermedades Diverticulares/complicaciones , Enfermedades Diverticulares/terapia , Divertículo del Colon/complicaciones , Divertículo del Colon/cirugía , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/cirugía , Hemostasis Endoscópica/efectos adversos , Ligadura/efectos adversos , Estudios Multicéntricos como Asunto , Estudios Retrospectivos
16.
Gastrointest Endosc ; 97(1): 89-99.e10, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-35931139

RESUMEN

BACKGROUND AND AIMS: We aimed to determine the optimal timing of colonoscopy and factors that benefit patients who undergo early colonoscopy for acute lower GI bleeding. METHODS: We identified 10,342 patients with acute hematochezia (CODE BLUE-J study) admitted to 49 hospitals in Japan. Of these, 6270 patients who underwent a colonoscopy within 120 hours were included in this study. The inverse probability of treatment weighting method was used to adjust for baseline characteristics among early (≤24 hours, n = 4133), elective (24-48 hours, n = 1137), and late (48-120 hours, n = 1000) colonoscopy. The average treatment effect was evaluated for outcomes. The primary outcome was 30-day rebleeding rate. RESULTS: The early group had a significantly higher rate of stigmata of recent hemorrhage (SRH) identification and a shorter length of stay than the elective and late groups. However, the 30-day rebleeding rate was significantly higher in the early group than in the elective and late groups. Interventional radiology (IVR) or surgery requirement and 30-day mortality did not significantly differ among groups. The interaction with heterogeneity of effects was observed between early and late colonoscopy and shock index (shock index <1, odds ratio [OR], 2.097; shock index ≥1, OR, 1.095; P for interaction = .038) and performance status (0-2, OR, 2.481; ≥3, OR, .458; P for interaction = .022) for 30-day rebleeding. Early colonoscopy had a significantly lower IVR or surgery requirement in the shock index ≥1 cohort (OR, .267; 95% confidence interval, .099-.721) compared with late colonoscopy. CONCLUSIONS: Early colonoscopy increased the rate of SRH identification and shortened the length of stay but involved an increased risk of rebleeding and did not improve mortality and IVR or surgery requirement. Early colonoscopy particularly benefited patients with a shock index ≥1 or performance status ≥3 at presentation.


Asunto(s)
Colonoscopía , Hemorragia Gastrointestinal , Humanos , Estudios Retrospectivos , Colonoscopía/métodos , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/terapia , Hemorragia Gastrointestinal/etiología , Enfermedad Aguda , Oportunidad Relativa
17.
Dig Dis ; 41(6): 890-899, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37669627

RESUMEN

INTRODUCTION: Weekend admissions showed increased mortality in several medical conditions. This study aimed to examine the weekend effect on acute lower gastrointestinal bleeding (ALGIB) and its mortality and other outcomes. METHODS: This retrospective cohort study (CODE BLUE-J Study) was conducted at 49 Japanese hospitals between January 2010 and December 2019. In total, 8,120 outpatients with acute hematochezia were enrolled and divided into weekend admissions and weekday admissions groups. Multiple imputation (MI) was used to handle missing values, followed by propensity score matching (PSM) to compare outcomes. The primary outcome was mortality; the secondary outcomes were rebleeding, length of stay (LOS), blood transfusion, thromboembolism, endoscopic treatment, the need for interventional radiology, and the need for surgery. Colonoscopy and computed tomography (CT) management were also evaluated. RESULTS: Before PSM, there was no significant difference in mortality (1.3% vs. 0.9%, p = 0.133) between weekend and weekday admissions. After PSM with MI, 1,976 cases were matched for each admission. Mortality was not significantly different for weekend admissions compared with weekday admissions (odds ratio [OR] 1.437, 95% confidence interval [CI] 0.785-2.630; p = 0.340). No significant difference was found with other secondary outcomes in weekend admissions except for blood transfusion (OR 1.239, 95% CI 1.084-1.417; p = 0.006). Weekend admission had a negative effect on early colonoscopy (OR 0.536, 95% CI 0.471-0.609; p < 0.001). Meanwhile, urgent CT remained significantly higher in weekend admissions (OR 1.466, 95% CI 1.295-1.660; p < 0.001). CONCLUSION: Weekend admissions decrease early colonoscopy and increase urgent CT but do not affect mortality or other outcomes except transfusion.


Asunto(s)
Hemorragia Gastrointestinal , Admisión del Paciente , Humanos , Japón/epidemiología , Estudios Retrospectivos , Mortalidad Hospitalaria , Factores de Tiempo , Tiempo de Internación , Hemorragia Gastrointestinal/terapia , Enfermedad Aguda
18.
J Gastroenterol Hepatol ; 38(5): 752-760, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-36565225

RESUMEN

BACKGROUND AND AIM: Cold snare polypectomy (CSP) is a standard treatment for small colorectal polyps. This study examined the effect of different snare wire diameters on complete histological resection rate, resection depth, and CSP safety. METHODS: This randomized controlled trial was conducted at two institutions between June 2019 and March 2021. Eligible colorectal polyps (≤10 mm) were randomly assigned in a 1:1 ratio to receive either CSP with a conventional snare made of normal-diameter wire (0.40 mm) or CSP with a dedicated snare made of thin wire (0.23 mm). The primary endpoint was the complete resection rate determined on histological assessment of the resected specimen. RESULTS: In total, 254 lesions in 152 patients were included, with 128 and 126 lesions assigned to the normal-diameter wire snare group and the thin-wire snare group, respectively. No significant differences were observed in patient characteristics between the two groups. The histological complete resection rate was significantly higher in the thin-wire snare group than in the normal-diameter wire snare group (70.0% vs 81.0%, P = 0.04). The normal-diameter wire snare group had significantly more cases of unclear horizontal margin evaluation than the thin-wire snare group (28.1% vs 15.9%, P = 0.02). No significant differences were observed between the two groups in the muscularis mucosa and submucosa of the resected specimens or the thickness of the submucosa in the resected specimens. CONCLUSIONS: CSP with a dedicated thin-wire snare provides more specimens that can be evaluated at the horizontal end and increases the histological complete resection rate.


Asunto(s)
Pólipos del Colon , Neoplasias Colorrectales , Humanos , Pólipos del Colon/cirugía , Pólipos del Colon/patología , Colonoscopía , Neoplasias Colorrectales/cirugía , Neoplasias Colorrectales/patología , Proyectos de Investigación
19.
Colorectal Dis ; 25(11): 2206-2216, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37787161

RESUMEN

AIM: No studies have compared the clinical outcomes of early and delayed feeding in patients with acute lower gastrointestinal bleeding (ALGIB). This study aimed to evaluate the benefits and risks of early feeding in a nationwide cohort of patients with ALGIB in whom haemostasis was achieved. METHODS: We reviewed data for 5910 patients with ALGIB in whom haemostasis was achieved and feeding was resumed within 3 days after colonoscopy at 49 hospitals across Japan (CODE BLUE-J Study). Patients were divided into an early feeding group (≤1 day, n = 3324) and a delayed feeding group (2-3 days, n = 2586). Clinical outcomes were compared between the groups by propensity matching analysis of 1508 pairs. RESULTS: There was no significant difference between the early and delayed feeding groups in the rebleeding rate within 7 days after colonoscopy (9.4% vs. 8.0%; p = 0.196) or in the rebleeding rate within 30 days (11.4% vs. 11.5%; p = 0.909). There was also no significant between-group difference in the need for interventional radiology or surgery or in mortality. However, the median length of hospital stay after colonoscopy was significantly shorter in the early feeding group (5 vs. 7 days; p < 0.001). These results were unchanged when subgroups of presumptive and definitive colonic diverticular bleeding were compared. CONCLUSION: The findings of this nationwide study suggest that early feeding after haemostasis can shorten the hospital stay in patients with ALGIB without increasing the risk of rebleeding.


Asunto(s)
Colonoscopía , Hemorragia Gastrointestinal , Humanos , Tiempo de Internación , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/terapia , Colonoscopía/métodos , Enfermedad Aguda , Estudios de Cohortes , Estudios Retrospectivos , Estudios Multicéntricos como Asunto
20.
Digestion ; 104(3): 165-173, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36423597

RESUMEN

INTRODUCTION: The purpose of this study was to optimize the surveillance frequency and period for efficient detection of early gastric cancer (EGC) after Helicobacter pylori (HP) eradication. METHODS: Data from patients with eradicated HP infection were extracted from the endoscopy databases of two institutions from January 2016 to March 2021. The patients were divided into a close follow-up group with frequent surveillance after eradication and an open follow-up group with an intermittent surveillance method, and the cases of post-eradication EGC found in the two groups were analyzed. RESULTS: Thirty-six out of 9,322 patients (0.39%) in the close follow-up group and 20 out of 11,436 patients (0.17%) in the open follow-up group were found to have EGC. The cumulative incidence of EGC after eradication was significantly higher in the close follow-up group (p = 0.004). The duration between eradication and EGC detection was significantly shorter in the close follow-up group (51.7 vs. 90.5 months, p = 0.002). A logistic regression model revealed that duration after eradication was an independent predictor for detecting EGC in the close follow-up group (p = 0.045). A Cox proportional hazards model revealed that the close follow-up strategy was effective in patients with an eradication duration of less than 65 months to identify EGC (p = 0.015), but there was no difference between the two strategies in patients with an eradication duration of more than 65 months (p = 0.624). DISCUSSION/CONCLUSIONS: Frequent surveillance after HP eradication is efficient for the early detection of EGC during the first 65 months.


Asunto(s)
Infecciones por Helicobacter , Helicobacter pylori , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/epidemiología , Neoplasias Gástricas/prevención & control , Estudios de Seguimiento , Endoscopía , Infecciones por Helicobacter/diagnóstico , Infecciones por Helicobacter/tratamiento farmacológico
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