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BACKGROUND: In familial adenomatous polyposis (FAP) patients, fundic gland polyps (FGPs) have been considered a risk factor for gastric neoplasms. We speculated that FGPs in FAP patients spread directionally from the greater to the lesser curvature of the gastric body and investigated the relationship between the distribution of FGPs and gastric neoplasm development. METHODS: We extracted 195 FAP patients from two institutions and reviewed their medical records. Gastric polyposis was classified based on the FGP distribution (P0, no FGPs; P1, localized in the fundus or greater curvature of the gastric body; P2, spreading to the anterior or posterior wall; P3, involving the proximal half of the lesser curvature; and P4, spreading from P3 to the anal side of the lesser curvature). RESULTS: The 195 eligible patients were divided into the neoplasm group (n = 54, 28%) and the non-neoplasm group (n = 141, 72%). Overall, 24% of the patients were Helicobacter pylori (H. pylori)-positive. In the FGP distribution, the rate of patients with gastric neoplasm tended to increase significantly with each step towards an increasingly wide distribution from P0 to P4 in H. pylori-negative patients, but not in H. pylori-positive ones. In addition, in H. pylori-negative patients, the likelihood of neoplasm increased consistently from P0 to P4, with the highest odds ratio (95% confidence interval) at P4 of 14.1 (2.5-154.4). Furthermore, multivariate analysis showed P4 and Spigelman stage ≥III were significantly associated with gastric neoplasm development. CONCLUSION: FGP distribution was correlated with gastric neoplasm development in FAP patients.
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Familial adenomatous polyposis (FAP) patients develop various life-threatening extracolonic comorbidities that appear individually or within a family. This diversity can be explained by the localization of the adenomatous polyposis coli (APC) variant, but few reports provide definitive findings about genotype-phenotype correlations. Therefore, we investigated FAP patients and the association between the severe phenotypes and APC variants. Of 247 FAP patients, 126 patients from 85 families identified to have APC germline variant sites were extracted. These sites were divided into six groups (Regions A to F), and the frequency of severe comorbidities was compared among the patient phenotypes. Of the 126 patients, the proportions of patients with desmoid tumor stage ≥III, number of FGPs ≥1000, multiple gastric neoplasms, gastric neoplasm with high-grade dysplasia, and Spigelman stage ≥III were 3%, 16%, 21%, 12%, and 41%, respectively, while the corresponding rates were 30%, 50%, 70%, 50%, and 80% in patients with Region E (codons 1398-1580) variants. These latter rates were significantly higher than those for patients with variants in other regions. Moreover, the proportion of patients with all three indicators (desmoid tumor stage ≥III, number of FGPs ≥1000, and Spigelman stage ≥III) was 20% for those with variants in Region E and 0% for those with variants in other regions. Variants in Region E indicate aggressive phenotypes, and more intensive management is required.
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Poliposis Adenomatosa del Colon , Fibromatosis Agresiva , Neoplasias Gástricas , Humanos , Genes APC , Fibromatosis Agresiva/genética , Genotipo , Poliposis Adenomatosa del Colon/genética , Poliposis Adenomatosa del Colon/patología , Fenotipo , Neoplasias Gástricas/genética , Neoplasias Gástricas/patología , Estudios de Asociación Genética , MutaciónRESUMEN
BACKGROUND: Patients with familial adenomatous polyposis (FAP) risk developing multiple duodenal adenomas (MDAs), leading to duodenal cancer and death. We investigated the efficacy and safety of intensive downstaging polypectomy (IDP) for MDAs integrated with new-generation procedures. METHODS: This prospective phase II study, conducted at a tertiary cancer center, enrolled patients with FAP who had MDAs. We performed IDP including cold snare/forceps polypectomy (CSP/CFP) and underwater endoscopic mucosal resection (UEMR). The primary end point was the downstaging of Spigelman stage at 1-year follow-up. RESULTS: 2424 duodenal polyps in 58 patients with FAP underwent IDP, including 2413 CSPs in 57 patients, seven CFPs in one patient, and four UEMRs in four patients. Only one major adverse event was observed (grade 3 hyperamylasemia) without clinical manifestations. We performed additional UEMR, CSP, and CFP for one, 12, and 22 patients, respectively, during initial follow-up.âOverall, 55 patients completed protocol examination; the Spigelman stage was significantly reduced at the 1-year follow-up endoscopy (Pâ<â0.001), with downstaging observed in 39 patients (71â%). Among the 26 patients with Spigelman stage IV at initial examination and protocol completion, 23 (88â%) showed downstaging. There was no major change in Spigelman stages from 1-year follow-up esophagogastroduodenoscopy to a median of 37 months (range 3-56). CONCLUSIONS: IDP, including new-generation procedures, showed significant downstaging with acceptable adverse events for MDA in patients with FAP, even those with advanced-stage disease. Lesion selection for different resection techniques may be important for suitable and sustainable management of MDA in patients with FAP.
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Poliposis Adenomatosa del Colon , Pólipos del Colon , Humanos , Estudios Prospectivos , Colonoscopía , Poliposis Adenomatosa del Colon/complicaciones , Poliposis Adenomatosa del Colon/cirugía , Poliposis Adenomatosa del Colon/patología , Endoscopía Gastrointestinal/métodosRESUMEN
BACKGROUND: Underwater endoscopic mucosal resection (UEMR) has been developed as an effective endoscopic intervention for colon, rectum, and duodenum neoplasms. However, there are no comprehensive reports regarding the stomach, and its safety and efficacy are unknown. We aimed to examine the feasibility of UEMR for gastric neoplasms in patients with familial adenomatous polyposis (FAP). METHODS: We retrospectively extracted data of patients with FAP who underwent endoscopic resection (ER) for gastric neoplasms at Osaka International Cancer Institute from February 2009 to December 2018. Elevated gastric neoplasms of ≤ 20 mm in diameter were extracted, and conventional endoscopic mucosal resection (CEMR) and UEMR were compared. Furthermore, outcomes after ER until March 2020 were examined. RESULTS: 91 endoscopically resected gastric neoplasms were extracted from 31 patients with 26 pedigrees, and 12 neoplasms underwent CEMR and 25 neoplasms underwent UEMR was compared. The procedure time was shorter for UEMR than for CEMR. There was no significant difference between en bloc resection and R0 resection rates by EMR methods. CEMR and UEMR showed postoperative hemorrhage rates of 8% and 0%, respectively. Residual/local recurrent neoplasms were identified in four lesions (4%), but additional endoscopic intervention (three UEMR and one cauterization) resulted in a local cure. CONCLUSION: UEMR was feasible in gastric neoplasms of FAP patients, especially in elevated lesions and those of ≤ 20 mm in diameter.
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Poliposis Adenomatosa del Colon , Resección Endoscópica de la Mucosa , Neoplasias Gástricas , Humanos , Colonoscopía/métodos , Resección Endoscópica de la Mucosa/métodos , Neoplasias Gástricas/cirugía , Estudios Retrospectivos , Estudios de Factibilidad , Poliposis Adenomatosa del Colon/cirugíaRESUMEN
BACKGROUND: Patients with familial adenomatous polyposis (FAP) have a lifetime risk of developing duodenal adenomas approaching 100%, and the relative risk for duodenal cancer compared with the general population is high. We conducted a retrospective study to investigate the progression of non-ampullary duodenal adenomas (NADAs) and risk factors for advanced lesions in patients with FAP. METHODS: Of 248 patients with 139 pedigrees at 2 institutes, we assessed 151 patients with 100 pedigrees with a pathogenic germline variant in the adenomatous polyposis coli gene, excluding mosaic variants. We evaluated the prevalence of NADAs in patients with FAP, the progression of these adenomas to advanced adenoma during the observation period, and the risk factors for the lifetime development of high-grade dysplasia (HGD), large (≥ 10 mm) duodenal adenomas, and Spiegelman stage IV. RESULTS: During the median observation period of 7 years, the incidences of patients with NADAs, with more than 20 polyps, with polyps ≥ 10 mm, with HGD, and with stage IV at the last esophagogastroduodenoscopy were increased 1.6-fold, 1.7-fold, 5-fold, 22-fold, and 9-fold, respectively. Intramucosal cancer occurred in three patients (2%), but no patients developed invasive cancer during the observation period because we performed endoscopic intervention for advanced adenomas. Stage progression was observed in 71% of 113 patients. Stage IV was more common in women, patients with a history of colectomy, and those with a 3' side mutation in their adenomatous polyposis coli gene. CONCLUSIONS: NADAs in patients with FAP frequently become exacerbated. Our findings suggest that patients with FAP who develop duodenal adenomas should be surveyed to prevent the development of duodenal cancer.
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BACKGROUND AND AIMS: Gastric neoplasms in patients with familial adenomatous polyposis (FAP) occur at a high rate and can cause death. The endoscopic findings of gastric neoplasms in these patients are characteristic but not well recognized. To identify the relevant characteristics to enable early detection, we retrospectively investigated endoscopic findings of gastric neoplasms in patients with FAP and then compared the clinical, histopathologic, and genetic features among subgroups. METHODS: Of 234 patients with 171 pedigrees at 2 institutes, 56 cases (24%, 133 gastric neoplasms) with 44 pedigrees were examined. Immunostaining was performed for histopathologic evaluation by 1 blinded pathologist. According to the endoscopic findings, gastric neoplasms were divided into 4 types based on location (L: antrum and pylorus, UM: the rest of the stomach) and color (W: white, T: translucent, R: reddish) and their clinicopathologic features examined. RESULTS: Of the cases, 93% could be classified into a single type. Among histologic phenotypes, high-grade dysplasia was present in 26% (type L), 41% (type UM-W), 0% (type UM-T), and 22% (type UM-R). The immunologic phenotype comprised the gastric type in 69% (93% in Type UM) and the intestinal phenotype, including the mixed type, in 31% (61% in type L). Moreover, 96% of patients had concurrent duodenal neoplasms. Adenomatous polyposis coli gene status was identified in 93% of patients; the pathogenic variant was detected in 98% but did not influence any endoscopic features. CONCLUSIONS: Gastric neoplasms in patients with FAP were stratified into 4 types according to their endoscopic findings. The endoscopic phenotype was related to the histopathologic phenotype but not to germline variants.
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Poliposis Adenomatosa del Colon , Neoplasias Duodenales , Neoplasias Gástricas , Poliposis Adenomatosa del Colon/complicaciones , Poliposis Adenomatosa del Colon/genética , Endoscopía , Humanos , Estudios RetrospectivosRESUMEN
BACKGROUND: Endoscopic ultrasonography (EUS) is reportedly the reliable modality to predict the depth of esophageal squamous cell carcinoma (ESCC), however, most previous studies are retrospective or single-centered. We aimed to evaluate the diagnostic ability of conventional endoscopy and EUS using the data from a multicenter prospective study of endoscopic resection (ER) followed by chemoradiotherapy for cSM1-2N0M0 ESCC (JCOG0508). METHODS: All lesions were evaluated as cSM cancer with both conventional endoscopy and EUS before enrollment and judged as cSM1 or cSM2 in real time. We compared the clinical and pathological diagnoses for tumor depth and assessed the positive predictive value (PPV) for pSM (pSM/cSM) as the primary endpoint. We also investigated the clinical factors affecting the pathological depth of SM. RESULTS: 175 lesions were examined, and clinical diagnosis was SM1 in 114 and SM2 in 61 lesions. The pathological diagnoses of the epithelium, lamina propria mucosa, muscularis mucosae, SM1, and SM2 were 3, 31, 55, 17, and 69. The PPV for pSM was 49.1% (86/175) in all lesions, 34.2% (39/114) in cSM1 lesions, and 77.0% (47/61) in cSM2 lesions. Multivariable analysis demonstrated that cSM2 (vs. cSM1, OR 6.79) was an independent clinical factor associated with pSM. CONCLUSIONS: While the accurate depth diagnosis in cSM ESCC was difficult to make, the clinical diagnosis of SM2 with both conventional endoscopy and EUS was significantly associated with pSM. Furthermore, diagnostic ER could be recommended to confirm the pathological diagnosis especially in cSM1 lesions with both conventional endoscopy and EUS.
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Neoplasias Esofágicas , Carcinoma de Células Escamosas de Esófago , Endoscopía Gastrointestinal , Endosonografía , Neoplasias Esofágicas/patología , Carcinoma de Células Escamosas de Esófago/cirugía , Humanos , Invasividad Neoplásica/patología , Estudios Prospectivos , Estudios RetrospectivosRESUMEN
BACKGROUND & AIMS: Esophagectomy is the standard treatment for stage I esophageal squamous cell carcinoma (ESCC). We conducted a single-arm prospective study to confirm the efficacy and safety of selective chemoradiotherapy (CRT) based on findings from endoscopic resection (ER). METHODS: We performed a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC from December 2006 through July 2012; 176 patients underwent ER. Based on the findings from ER, patients received the following: no additional treatment for patients with pT1a tumors with a negative resection margin and no lymphovascular invasion (group A); prophylactic CRT with 41.4 Gy delivered to locoregional lymph nodes for patients with pT1b tumors with a negative resection margin or pT1a tumors with lymphovascular invasion (group B); or definitive CRT (50.4 Gy) with a 9-Gy boost to the primary site for patients with a positive vertical resection margin (group C). Chemotherapy comprised 5-fluorouracil and cisplatin. The primary end point was 3-year overall survival in group B, and the key secondary end point was 3-year overall survival for all patients. If lower limits of 90% confidence intervals for the primary and key secondary end points exceeded the 80% threshold, the efficacy of combined ER and selective CRT was confirmed. RESULTS: Based on the results from pathology analysis, 74, 87, and 15 patients were categorized into groups A, B, and C, respectively. The 3-year overall survival rates were 90.7% for group B (90% confidence interval, 84.0%-94.7%) and 92.6% in all patients (90% confidence interval, 88.5%-95.2%). CONCLUSIONS: In a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC, we confirmed the efficacy of the combination of ER and selective CRT. Efficacy is comparable to that of surgery, and the combination of ER and selective CRT should be considered as a minimally invasive treatment option. UMIN-Clinical Trials Registry no.: UMIN000000553.
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Neoplasias Esofágicas/terapia , Carcinoma de Células Escamosas de Esófago/terapia , Esofagectomía/métodos , Esofagoscopía/métodos , Adulto , Anciano , Quimioradioterapia Adyuvante , Neoplasias Esofágicas/mortalidad , Neoplasias Esofágicas/patología , Carcinoma de Células Escamosas de Esófago/mortalidad , Carcinoma de Células Escamosas de Esófago/patología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Estudios Prospectivos , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
Mesalazine is the gold standard drug for treatment of ulcerative colitis (UC). Here, we describe 4 cases of familial adenomatous polyposis (FAP) patients with UC that showed reduction of intestinal polyp diameter by mesalazine treatment. Of note, the effects of mesalazine on the development of intestinal polyps in FAP patients have not been reported, and we further investigated whether the short-term use of high-dose mesalazine (4 g/day) has harmful effects on FAP patients or not. The authors found that the treatment showed slightly adverse events in FAP patients. However, mesalazine tended to reduce the number of colon polyps in male subjects with FAP. This report provides basic information for planning a double-blind, randomized, clinical trial that aims to show mesalazine's potential to suppress intestinal polyp development in FAP.
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Poliposis Adenomatosa del Colon/tratamiento farmacológico , Antiinflamatorios no Esteroideos/administración & dosificación , Colitis Ulcerosa/tratamiento farmacológico , Mesalamina/administración & dosificación , Poliposis Adenomatosa del Colon/complicaciones , Poliposis Adenomatosa del Colon/patología , Administración Oral , Adulto , Antiinflamatorios no Esteroideos/efectos adversos , Colitis Ulcerosa/complicaciones , Colitis Ulcerosa/patología , Colon/diagnóstico por imagen , Colon/efectos de los fármacos , Colon/patología , Colonoscopía , Relación Dosis-Respuesta a Droga , Estudios de Seguimiento , Humanos , Mucosa Intestinal/diagnóstico por imagen , Mucosa Intestinal/efectos de los fármacos , Mucosa Intestinal/patología , Masculino , Mesalamina/efectos adversos , Proyectos Piloto , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Cold snare polypectomy (CSP) to remove multiple duodenal adenomas (MDAs) in patients with familial adenomatous polyposis (FAP) could be an effective and less invasive method than more extensive surgery. The aim of the present study was to determine the safety of this procedure. METHODS: This prospective exploratory study included 10 consecutive patients with FAP and MDAs who underwent CSP for as many as 50 duodenal adenomas. The primary outcome was the incidence of severe adverse events. RESULTS: 10 patients were enrolled and underwent 332 CSPs from June 2016 to January 2017.âThe median procedure time was 33 minutes (range 25â-â53), and the median number of polyps removed during a single session was 35 (range 10â-â50). Most of the removed polyps wereâ≤â10âmm. None of the 10 patients experienced a severe adverse event. One patient developed arterial bleeding during the procedure, but it was easily managed using hemoclips. CONCLUSIONS: CSP for MDAs in patients with FAP was safe. The long-term efficacy of this procedure should be investigated.
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Adenoma/cirugía , Poliposis Adenomatosa del Colon/cirugía , Criocirugía/instrumentación , Neoplasias Duodenales/cirugía , Endoscopía/instrumentación , Complicaciones Posoperatorias/epidemiología , Adenoma/patología , Poliposis Adenomatosa del Colon/patología , Adulto , Criocirugía/efectos adversos , Neoplasias Duodenales/patología , Endoscopía/efectos adversos , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Tempo Operativo , Estudios Prospectivos , Resultado del TratamientoRESUMEN
Endoscopic treatments, including endoscopic mucosal resection or endoscopic submucosal dissection, are well accepted as standard treatments for early gastric cancers. However, there are few studies evaluating the safety and efficacy of this approach for early gastric cancers in patients aged over 80 years, and the post-treatment prognosis remains unclear. Here, we retrospectively analyzed the medical records and evaluated the safety and efficacy of endoscopic treatment for early gastric cancers in patients aged over 80 years (group A) compared with non-elderly patients aged 65-79 years (group B) and under 65 years (group C). In this study, we enrolled 53 patients (mean age, 82 years) in group A, 217 patients (mean age, 73 years) in group B, and 89 patients (mean age, 60 years) in group C who received endoscopic treatment at Kyoto University Hospital between 2001 and 2010. The incidence of treatment-related complications including aspiration pneumonia, bleeding, and perforation was 19% (10/53) in group A, 9.7% (21/217) in group B, and 6.7% (6/89) in group C, respectively. In particular, only the incidence of aspiration pneumonia was significantly higher in group A [11% (6/53) ] than in the other two groups [1.8% (4/217) in group B and 1.1% (1/89) in group C]. There was no significant difference in the curative resection rate and recurrence rate including metachronous lesions among the three groups. In group A, the median survival calculated using the Kaplan-Meier method was 8.0 years, and the 5-year survival rate was 73%. No gastric cancer-related deaths were observed in all groups. In conclusion, endoscopic treatment for early gastric cancers may contribute to an improvement in life expectancy, even among patients aged over 80 years, provided an experienced gastroenterologist selects the appropriate patients based on not only the endoscopic findings for the lesion but also the severity of any comorbidities. However, it is noteworthy that our elderly group aged over 80 years had a high risk of developing aspiration pneumonia.
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Resección Endoscópica de la Mucosa , Neoplasias Gástricas/terapia , Anciano , Anciano de 80 o más Años , Detección Precoz del Cáncer , Mucosa Gástrica , Gastroscopía , Humanos , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Estudios Retrospectivos , Neoplasias Gástricas/diagnóstico , Resultado del TratamientoRESUMEN
BACKGROUND AND STUDY AIMS: Colectomy protects against colorectal cancer in familial adenomatous polyposis (FAP); however, some patients with FAP refuse surgery. The aim of this study was to evaluate the feasibility and safety of endoscopic management of these patients. PATIENTS AND METHODS: A retrospective review of medical records was performed to identify adult patients with FAP who refused colectomy and were managed by repeated colonoscopies to remove numerous polyps between 2001 and 2012.âPolyps were removed by hot snare polypectomy or endoscopic mucosal resection. Polyps of <â10âmm in size and without endoscopic features suggesting cancer were discarded without histological examination; the remaining polyps were examined histologically. RESULTS: Of the 95 eligible patients, five (5.3â%) were excluded. The remaining 90 patients (median age at first visit 29 years [range 16â-â68 years]; 46 males) were followed for a median of 5.1 years (interquartile range [IQR] 3.3â-â7.3 years). During this period, a total of 55â701 polyps were resected without adverse events such as bleeding or perforation. The median numbers of endoscopic treatment sessions and polyps removed per patient were 8 (IQR 6â-â11) and 475 (IQR 211â-â945), respectively. Five patients had noninvasive carcinoma (Category 4.2 according to the revised Vienna classification), detected within 10 months from the start of the follow-up period. All of these patients were treated endoscopically, without signs of recurrence during a median follow-up of 4.3 years (IQR 2.0â-â7.1 years). No invasive colorectal cancer was recorded during the study period. Two patients (2.2â%) underwent colectomy because the polyposis phenotype had changed to dense polyposis. CONCLUSION: Endoscopic management of FAP is feasible and safe in the medium term.
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Poliposis Adenomatosa del Colon/cirugía , Colectomía , Colonoscopía , Adolescente , Adulto , Anciano , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Adulto JovenRESUMEN
BACKGROUND: The multidiameter balloon catheter is used widely for severe esophageal stricture dilation. However, the relationships between inflation pressure, balloon size, and radial dilation force at the stricture site have not been examined fully. METHODS: We performed an experiment using phantom models to investigate the relationships between inflation pressure, balloon size, and radial dilation force. The balloon dilation procedure was performed for each stricture model using three sizes of balloon: 10-11-12, 12-13.5-15, and 15-16.5-18 mm. RESULTS: A positive association between inflation pressure and dilation force was observed for each balloon size. In balloons inflated by targeting the same diameter, the dilation force was higher for smaller balloons than for larger balloons. An inverse association between stricture size and dilation force was observed in the 12-13.5-15 mm balloon (3 vs 5 mm, P = .002; 5 vs 7 mm, P < .001). CONCLUSIONS: We found relationships between inflation pressure, balloon size, severity of strictures, and dilation force. To perform safe and effective esophageal balloon dilation, the inflation pressure and balloon size should be selected after considering the stricture size and target diameter.
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Cateterismo/instrumentación , Dilatación/métodos , Estenosis Esofágica/terapia , Modelos Biológicos , Dilatación/instrumentación , Diseño de Equipo , Humanos , Fenómenos Mecánicos , PresiónRESUMEN
BACKGROUND AND PURPOSE: Distant metastasis (DM) after definitive chemoradiotherapy has not been a focus of research in esophageal carcinoma. At present, local-regional control is improving following advances in salvage treatments after definitive chemoradiotherapy. There is a need to focus on suppressing the development of DM. The aim of this study was to identify pre-treatment factors associated with DM after definitive chemoradiotherapy. MATERIALS AND METHODS: This study included 144 patients with thoracic esophageal squamous cell carcinoma (Stage I/II/III/IV; 35/17/69/23) (TNM 7th) who underwent definitive chemoradiotherapy; >50 Gy was prescribed to all gross tumors with concurrent administration of 5-fluorouracil ± platinum. Pre-treatment factors included age, gender, performance status, tumor location, T/N/M status, tumor length, size of metastatic lymph nodes (LN size), and the presence of intramural metastasis or multiple primary tumors. The effects of pre-treatment factors on overall survival (OS) and DM were evaluated. RESULTS: The median follow-up period was 48 months. DM occurred as an initial progression in 21 % of patients, and LN size correlated with DM development (hazard ratio [HR] = 5.12; p = 0.0013) and poor OS (HR = 2.20; p = 0.0076) in univariate and multivariate analyses. CONCLUSIONS: LN size is a quantitative pre-treatment prognostic factor that should be assessed prior to definitive chemoradiotherapy. Patients with large metastatic lymph nodes are at high risk of DM and should be monitored.
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Carcinoma de Células Escamosas/secundario , Carcinoma de Células Escamosas/terapia , Neoplasias Esofágicas/patología , Neoplasias Esofágicas/terapia , Ganglios Linfáticos/patología , Adulto , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioradioterapia , Femenino , Fluorouracilo/administración & dosificación , Estudios de Seguimiento , Humanos , Metástasis Linfática , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Tamaño de los Órganos , Compuestos de Platino/administración & dosificación , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia , Carga TumoralRESUMEN
BACKGROUND: Despite rising healthcare costs, generic drugs are less frequently dispensed in Japan compared with other developed countries. This study aimed to describe changes in dispensing of branded and generic drugs and to explore possible factors that promote the use of generic drugs. METHODS: We conducted a retrospective cohort study using a Japanese medical and pharmacy claims database. All proton pump inhibitors (PPIs) and histamine H2-receptor antagonists (H2RAs) with indications for gastroesophageal reflux disease (GERD) described on Japanese labels were included. Patterns of dispensing branded and generic drugs for the treatment of GERD between 2006 and 2011 were analyzed. Multivariate logistic regression was applied to investigate factors associated with receiving generic drugs. RESULTS: The study cohort included 14,590 patients (male: 50.2%, mean age: 43.1 years). Branded drugs for GERD were still frequently dispensed despite an increase in the share of generic drugs. Only 4.3% of patients who initially received branded drugs switched to generic drugs. The percentage of patients who received only generic drugs increased over time (6.5% to 22.1%). The frequency of generic drug dispensing was the highest in the setting where both prescription and dispensing were implemented in clinics (43.3%), while the lowest in the setting where both prescription and dispensing were implemented in hospitals (11.5%). Factors associated with receiving generic drugs included year of dispensing (adjusted OR 2.22, 95% CI 1.94 to 2.55 for 2009-11 v 2006-8), prescription and dispensing setting (OR 1.81, 95% CI 1.44 to 2.26 for prescription in hospitals and dispensing in community pharmacies; OR 2.21, 95% CI 1.80 to 2.72 for prescription in clinics and dispensing in community pharmacies; and OR 4.55, 95% CI 3.68 to 5.62 for prescription and dispensing in clinics v prescription and dispensing in hospitals) and H2RAs (OR 1.64, 95% CI 1.49 to 1.81 compared to PPIs). CONCLUSIONS: The share of generic drugs for the treatment of GERD increased over time although branded drugs for GERD were still dispensed frequently. The use of generic drugs for GERD was influenced not only by government policies but also by changes in treatment approach and the setting of prescription and dispensing.
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Prescripciones de Medicamentos/estadística & datos numéricos , Sustitución de Medicamentos/estadística & datos numéricos , Medicamentos Genéricos/uso terapéutico , Reflujo Gastroesofágico/tratamiento farmacológico , Costos de la Atención en Salud/estadística & datos numéricos , Antagonistas de los Receptores H2 de la Histamina/uso terapéutico , Inhibidores de la Bomba de Protones/uso terapéutico , Adolescente , Adulto , Anciano , Estudios de Cohortes , Países Desarrollados/estadística & datos numéricos , Femenino , Humanos , Japón , Masculino , Persona de Mediana Edad , Análisis Multivariante , Inhibidores de la Bomba de Protones/economía , Estudios Retrospectivos , Adulto JovenRESUMEN
BACKGROUND: We previously reported that magnifying narrow-band imaging (M-NBI) is a high-performance diagnostic tool for small, depressed gastric cancer. However, an efficient diagnostic strategy using endoscopic findings has not been fully elucidated. OBJECTIVE: To identify the endoscopic findings that contribute to accurate diagnosis of small, depressed gastric cancer and to propose the ideal diagnostic approach to such lesions. DESIGN: Post-hoc analysis of a prospective, randomized, controlled trial. SETTING: Nine hospitals. PATIENTS: Three hundred fifty-three patients with small, depressed gastric lesions. INTERVENTIONS: In the M-NBI group (n = 177), cancer diagnosis was made with diagnostic criteria including a demarcation line (DL) and an irregular microvascular pattern (IMVP). In the conventional white-light imaging (C-WLI) group (n = 176), diagnostic criteria were both an irregular margin and a spiny depressed area. In the C-WLI group, M-NBI was performed after C-WLI diagnosis. MAIN OUTCOME MEASUREMENTS: The diagnostic performance of each criterion in M-NBI alone, C-WLI, and M-NBI after C-WLI was investigated. RESULTS: M-NBI after C-WLI ultimately showed the best diagnostic performance in each diagnostic criterion. In M-NBI after C-WLI, evaluation of DL is technically easier than that of IMVP, and DL alone had a high sensitivity (95%) and negative predictive value (99%). The IMVP in M-NBI after C-WLI had a high sensitivity and specificity (95% and 96%, respectively) for diagnosis of cancer. LIMITATIONS: Lesions were limited to the small, depressed type. CONCLUSIONS: For a diagnosis using M-NBI after C-WLI, identification of DL is the first step, and subsequent inspection of IMVP diagnosed by DL is an efficient strategy.
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Gastroscopía/métodos , Imagen de Banda Estrecha , Neoplasias Gástricas/diagnóstico , Anciano , Femenino , Humanos , Masculino , Imagen de Banda Estrecha/métodos , Valor Predictivo de las Pruebas , Estudios Prospectivos , Neoplasias Gástricas/patologíaRESUMEN
Endoscopy is essential for the diagnosis and treatment of cancers derived from the gastrointestinal tract. However, a conventional white-light image has technical limitations in detecting small or superficial lesions. Narrow-band imaging, especially with magnification, allows visualization of microstructure patterns and microvascular patterns on the mucosal surface. These technical breakthroughs enable endoscopists to easily detect small pre-neoplastic and neoplastic lesions and to make a differential diagnosis of these lesions. Appropriate diagnosis with narrow-band imaging contributes to minimally invasive endoscopic resection.
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Endoscopía Gastrointestinal , Neoplasias Gastrointestinales/diagnóstico , Neoplasias de Cabeza y Cuello/diagnóstico , Imagen de Banda Estrecha , Tracto Gastrointestinal Superior/patología , Adenocarcinoma/diagnóstico , Esófago de Barrett/diagnóstico , Carcinoma de Células Escamosas/diagnóstico , Diagnóstico Diferencial , Neoplasias Duodenales/diagnóstico , Detección Precoz del Cáncer , Endoscopía Gastrointestinal/instrumentación , Endoscopía Gastrointestinal/métodos , Neoplasias Esofágicas/diagnóstico , Reflujo Gastroesofágico/diagnóstico , Neoplasias Gastrointestinales/patología , Neoplasias de Cabeza y Cuello/patología , Humanos , Neoplasias Gástricas/diagnósticoRESUMEN
BACKGROUND & AIMS: It is difficult to accurately diagnose patients with depressed gastric mucosal cancer based on conventional white-light imaging (C-WLI) endoscopy. We compared the real-time diagnostic yield of C-WLI for small, depressed gastric mucosal cancers with that of magnifying narrow-band imaging (M-NBI). METHODS: We performed a multicenter, prospective, randomized, controlled trial of patients with undiagnosed depressed lesions ≤10 mm in diameter identified by esophagogastroduodenoscopy. Patients were randomly assigned to groups that were analyzed by C-WLI (n = 176) or M-NBI (n = 177) immediately after detection; the C-WLI group received M-NBI after C-WLI. We compared the diagnostic accuracy, sensitivity, and specificity between C-WLI and M-NBI and assessed the diagnostic yield of M-NBI conducted in conjunction with C-WLI. RESULTS: Overall, 40 gastric cancers (20 in each group) were identified. The median diagnostic values for M-NBI and C-WLI were as follows: accuracy, 90.4% and 64.8%; sensitivity, 60.0% and 40.0%; and specificity, 94.3% and 67.9%, respectively. The accuracy and specificity of M-NBI were greater than those of C-WLI (P < .001); the difference in sensitivity was not significant (P = .34). The combination of M-NBI with C-WLI significantly enhanced performance compared with C-WLI alone; accuracy increased from (median) 64.8% to 96.6% (P < .001), sensitivity increased from 40.0% to 95.0% (P < .001), and specificity increased from 67.9% to 96.8% (P < .001). CONCLUSIONS: M-NBI, in conjunction with C-WLI, identifies small, depressed gastric mucosal cancers with 96.6% accuracy, 95.0% sensitivity, and 96.8% specificity. These values are better than for C-WLI or M-NBI alone.
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Adenocarcinoma/diagnóstico , Diagnóstico por Imagen/métodos , Endoscopía Gastrointestinal , Mucosa Gástrica/patología , Neoplasias Gástricas/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Diagnóstico Precoz , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Reproducibilidad de los Resultados , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: There is no effective treatment for gastroesophageal anastomotic strictures that are refractory to repeated endoscopic balloon dilation (EBD). However, EBD is still selected worldwide to manage such refractory strictures. To relieve the symptoms of dysphagia and keep a wide lumen, we developed a new incisional treatment, radial incision and cutting (RIC). OBJECTIVE: To evaluate the efficacy and safety of the RIC method for the treatment of refractory anastomotic strictures. DESIGN: Retrospective cohort study. SETTING: National Cancer Center and University Hospital. PATIENTS: This study involved 54 consecutive patients with refractory anastomotic stricture after esophagogastric surgery. INTERVENTION: RIC. MAIN OUTCOME MEASUREMENTS: The safety and clinical success of RIC and the long-term patency after RIC compared with those of continued EBD. RESULTS: The median procedure time of RIC was 14 minutes (range, 4-40 minutes). No serious adverse events associated with RIC were observed. Immediately after RIC, 81.3% (26/32) of patients were able to eat solid food without symptoms of dysphagia. As a short-term effect, the dysphagia improved after RIC in 93.8% (30/32) of the patients. As a long-term effect, 63% (17/27) and 62% (13/21) of patients were able to eat solid food 6 and 12 months after RIC, respectively. The 6-month and 12-month patency rates were significantly different between the RIC group and the continued EBD group (65.3% vs 19.8%, P < .005; 61.5% vs 19.8%, P < .005). LIMITATIONS: Nonrandomized retrospective study. CONCLUSIONS: RIC is an effective and safe method. The demonstration of the validity of this method may place RIC as a new medical treatment for patients with refractory stricture after surgical resection for esophagogastric diseases.
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Cateterismo , Trastornos de Deglución/cirugía , Estenosis Esofágica/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Distribución de Chi-Cuadrado , Trastornos de Deglución/etiología , Trastornos de Deglución/terapia , Ingestión de Alimentos , Estenosis Esofágica/complicaciones , Estenosis Esofágica/terapia , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias , Recurrencia , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Estadísticas no Paramétricas , Factores de Tiempo , Insuficiencia del TratamientoRESUMEN
Background and Aims: Multiple developments of squamous dysplasia and squamous cell carcinoma (SCC) in the upper aerodigestive tract have been explained by field cancerization phenomenon and were associated with alcohol and cigarette use. Second primary SCC development after curative treatment impairs patients' quality of life and survival; however, how these consumption and cessation affect field cancerization is still unknown. Methods: This is a multicenter cohort study including 331 patients with superficial esophageal SCC (ESCC) treated endoscopically and pooled data from 1022 healthy subjects for comparison. Physiological condition in the background esophageal mucosa was classified into 3 groups based on the number of Lugol-voiding lesions (LVLs) per endoscopic view: grade A, 0; grade B, 1-9; or grade C, ≥10 LVLs. Lifestyle surveys were conducted using a self-administered questionnaire. Patients were counseled on the need for alcohol and smoking cessation by physicians and were endoscopically surveyed every 6 months. Results: LVL grades were positively associated with alcohol drinking intensity, flushing reactions, smoking, and high-temperature food and were negatively associated with eating green and yellow vegetables and fruit. Second primary ESCC and head/neck SCC were significantly more prevalent in the grade C LVL (cumulative 5-y incidences 47.1%, 95% confidence interval [CI] = 38.0-57.2 and 13.3%, 95% CI = 8.1-21.5, respectively). Alcohol and smoking cessation significantly reduced the development of second primary ESCC (adjusted hazard ratios 0.47, 95% = CI 0.26-0.85 and 0.49, 95% CI = 0.26-0.91, respectively). Conclusion: Alcohol drinking, smoking, flushing reaction, and high-temperature food were closely associated with field cancerization, and cessation of alcohol and smoking significantly reduced the risk of development of second primary cancer. UMIN Clinical Trials Registry ID:UMIN000001676.