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16 result(s) for "Keiichiro Nakajo"
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Comparison of Effective Imaging Modalities for Detecting Gastric Neoplasms: A Randomized 3-Arm Phase II Trial
INTRODUCTION:The early detection of gastric neoplasms (GNs) leads to favorable treatment outcomes. The latest endoscopic system, EVIS X1, includes third-generation narrow-band imaging (3G-NBI), texture and color enhancement imaging (TXI), and high-definition white-light imaging (WLI). Therefore, this randomized phase II trial aimed to identify the most promising imaging modality for GN detection using 3G-NBI and TXI.METHODS:Patients with scheduled surveillance endoscopy after a history of esophageal cancer or GN or preoperative endoscopy for known esophageal cancer or GN were randomly assigned to the 3G-NBI, TXI, or WLI groups. Endoscopic observations were performed to detect new GN lesions, and all suspected lesions were biopsied. The primary endpoint was the GN detection rate during primary observation. Secondary endpoints were the rate of missed GNs, early gastric cancer detection rate, and positive predictive value for a GN diagnosis. The decision rule had a higher GN detection rate between 3G-NBI and TXI, outperforming WLI by >1.0%.RESULTS:Finally, 901 patients were enrolled and assigned to the 3G-NBI, TXI, and WLI groups (300, 300, and 301 patients, respectively). GN detection rates in the 3G-NBI, TXI, and WLI groups were 7.3, 5.0, and 5.6%, respectively. The rates of missed GNs were 1.0, 0.7, and 1.0%, the detection rates of early gastric cancer were 5.7, 4.0, and 5.6%, and the positive predictive values for the diagnosis of GN were 36.5, 21.3, and 36.8% in the 3G-NBI, TXI, and WLI groups, respectively.DISCUSSION:Compared with TXI and WLI, 3G-NBI is a more promising modality for GN detection.
Impact of the Charlson Comorbidity Index on the treatment strategy and survival in elderly patients after non-curative endoscopic submucosal dissection for esophageal squamous cell carcinoma: a multicenter retrospective study
BackgroundIn elderly patients with superficial esophageal squamous cell carcinoma (ESCC), the optimal treatment strategy after non-curative endoscopic submucosal dissection (ESD) remains unclear. We aimed to evaluate the validity of additional treatments after non-curative ESD and post-ESD survival predictors in elderly patients with ESCC.MethodsElderly patients (age > 75 years) treated with ESD for ESCC between January 2010 and July 2014 at six tertiary referral hospitals in Japan were retrospectively investigated and stratified according to lymph node metastasis risk, based on histological findings (high-risk factors: positive lymphovascular invasion, submucosal invasion, and positive/indeterminate vertical margin) and post-ESD treatment strategy: group A (287 patients; low risk), group B (41 patients; high risk, without additional treatment), and group C (32 patients; high risk, with additional treatment). We evaluated 3- and 5-year overall survival and disease-specific survival, and prognostic factors for post-ESD survival.ResultsAt a median follow-up of 38, 40, and 49 months, respectively, there was 1 esophageal cancer-related death in group A, 1 in group B, and none in group C, whereas 22, 9, and 3 patients in groups A, B, and C died of other diseases. The groups differed significantly in overall survival (92.4%; 87.6%; 93.4%, p = 0.022), although not in disease-specific survival (99.4%; 96.3%; 100%, p = 0.217). On multivariate analysis, Charlson Comorbidity Index (CCI) ≥ 2 was the only independent risk factor for post-ESD death (hazard ratio 7.92; 95% confidence interval 3.42–18.3; p < 0.001).ConclusionsA follow-up strategy without additional treatment after ESD for ESCC may be acceptable in high-risk elderly patients, especially for CCI ≥ 2.
Clinical Practice of Photodynamic Therapy Using Talaporfin Sodium for Esophageal Cancer
Photodynamic therapy (PDT) using a conventional photosensitizer was approved for esophageal cancer in the early 1990s; however, it was replaced by other conventional treatment modalities in clinical practice because of the high frequency of cutaneous phototoxicity and esophageal stricture after the procedure. The second-generation photosensitizer, talaporfin sodium, which features more rapid clearance from the body, was developed to reduce skin phototoxicity, and talaporfin sodium can be excited at longer-wavelength lights comparing with a conventional photosensitizer. Endoscopic PDT using talaporfin sodium was initially developed for the curative treatment of central-type early lung cancer in Japan, and was approved in the early 2000s. After preclinical experiments, PDT using talaporfin sodium was investigated for patients with local failure after chemoradiotherapy, which was the most serious unmet need in the practice of esophageal cancer. According to the favorable results of a multi-institutional clinical trial, PDT using talaporfin sodium was approved as an endoscopic salvage treatment for patients with local failure after chemoradiotherapy for esophageal cancer. While PDT using talaporfin sodium is gradually spreading in clinical practice, further evaluation at the point of clinical benefit is necessary to determine the importance of PDT in the treatment of esophageal cancer.
Computer-aided demarcation of early gastric cancer: a pilot comparative study with endoscopists
BackgroundPrecise area diagnosis of early gastric cancer (EGC) is critical for reliable endoscopic resection. Computer-aided diagnosis (CAD) shows strong potential for detecting EGC and reducing cancer-care disparities caused by differences in endoscopists’ skills. To be used in clinical practice, CAD should enable both the detection and the demarcation of lesions. This study proposes a scheme for the detection and delineation of EGC under white-light endoscopy and validates its performance using 1-year consecutive cases.MethodsOnly 300 endoscopic images randomly selected from 68 consecutive cases were used for training a convolutional neural network. All cases were treated with endoscopic submucosal dissection, enabling the accumulation of a training dataset in which the extent of lesions was precisely determined. For validation, 462 cancer images and 396 normal images from 137 consecutive cases were used. From the validation results, 38 randomly selected images were compared with those delineated by six endoscopists.ResultsSuccessful detections of EGC in 387 cancer images (83.8%) and the absence of lesions in 307 normal images (77.5%) were achieved. Positive and negative predictive values were 81.3% and 80.4%, respectively. Successful detection was achieved in 130 cases (94.9%). We achieved precise demarcation of EGC with a mean intersection over union of 66.5%, showing the extent of lesions with a smooth boundary; the results were comparable to those achieved by specialists.ConclusionsOur scheme, validated using 1-year consecutive cases, shows potential for demarcating EGC. Its performance matched that of specialists; it might therefore be suitable for clinical use in the future.
Factors of technical difficulty in conventional and traction-assisted esophageal endoscopic submucosal dissection
Background The traction assisted (TA) method has reduced the technical difficulty associated with esophageal endoscopic submucosal dissection (ESD). However, it is unclear which factors associated with difficulty have been improved by the TA-ESD method. We aimed to evaluate and compare difficulty factors between conventional and TA-ESD. Methods We retrospectively enrolled patients treated by ESD from Apr 2010 to Jun 2014 for the conventional ESD cohort and from Jan 2016 to Dec 2019 for the TA-ESD cohort. Difficult cases were defined as; (1)  ≥ 120 min ESD procedure time, (2) intraoperative perforation, or (3) piecemeal resection. We explored and compared the factors associated with technical difficulty in each cohort. Results The conventional and TA-ESD cohorts included 285 (299 lesions) and 387 (421 lesions) patients, respectively. For difficult cases, the conventional and TA-ESD cohorts had 91 (30%) and 71 (17%) lesions, respectively. Multivariate logistic regression showed that ≥ 30 mm lesion length (odds ratio (OR) 6.85, 95% confidence interval (CI) 3.47–13.50), lower esophagus (OR 2.37, 95% Cl 1.34–4.21), > 1/2 circumference (OR 2.26, 95% CI 1.28–3.99), and left wall (OR 2.72, 95% CI 1.42–5.20) in the conventional ESD cohort, and ≥ 30 mm lesion length (21.30, 95% CI 4.75–95.30), lower esophagus (OR 3.05, 95% CI 1.52–6.13), and > 1/2 circumference (OR 6.40, 95% CI 3.06–13.40) in the TA-ESD cohort, were independently associated with technical difficulty. Conclusions TA-ESD can reduce the difficulty in cases including lesions in the left wall; however, cases in the lower esophagus and large lesions were still difficult to simplify.
The usefulness of a double-balloon endolumenal interventional platform for colorectal endoscopic submucosal dissection by non-expert endoscopists in a porcine model (with video)
BackgroundEndoscopic submucosal dissection (ESD) is an optimal treatment for colorectal tumors; however, it is technically difficult, especially for non-experts. Therefore, a device that helps non-experts perform colorectal ESD would be beneficial. A double-balloon endolumenal interventional platform (DEIP) was recently developed to assist colorectal ESD through endoscope stabilization and traction. This study assessed the usefulness of colorectal ESD using the DEIP (DEIP-ESD) by endoscopists, including non-experts, in a living porcine model.MethodsTwo pigs were used to perform eight DEIP-ESD and eight conventional cap-assisted ESD (C-ESD) procedures. Three experts and five non-experts each resected one lesion using DEIP-ESD and one using C-ESD. We evaluated the treatment outcomes and performed stratified analyses between the experts and non-experts.ResultsDissection speed was significantly faster in DEIP-ESD than in C-ESD (13.3 mm2/min vs 28.5 mm2/min, P = 0.002). However, the total procedure time did not differ significantly between DEIP-ESD and C-ESD. In the stratified analyses, the dissection speed of non-experts was significantly faster in DEIP-ESD than in C-ESD (10.9 mm2/min vs 25.1 mm2/min, P = 0.016), while that of experts increased in DEIP-ESD but to a lesser extent (19.1 mm2/min vs 28.8 mm2/min, P = 0.1). The total procedure time did not differ between DEIP-ESD and C-ESD for both experts and non-experts. The self-completion rate of non-experts also increased in DEIP-ESD. Moreover, the number of muscularis propria injuries induced by non-experts was fewer in DEIP-ESD than in C-ESD.ConclusionsDEIP could facilitate colorectal ESD by improving dissection efficiency without increasing adverse events, especially when performed by non-experts.
Long-term clinical outcomes of patients diagnosed with pT1a-muscularis mucosae with lymphovascular invasion or pT1b after endoscopic resection for cT1N0M0 esophageal squamous cell carcinoma
Background Endoscopic resection (ER) is performed for early esophageal squamous cell carcinoma (ESCC) cases. Additional esophagectomy or chemoradiotherapy is recommended for non-curative resection (NCR) even with pathologically negative vertical margins (pVM0); however, their clinical outcomes remain unknown. We examined the long-term clinical outcomes of NCR for ESCCs according to additional treatments. Methods We retrospectively analyzed the data of patients who underwent ER for cT1N0M0 ESCC between 2009 and 2017 judged to have NCR, which defined when pathologically diagnosed as invading the submucosa (SM) or muscularis mucosae (MM) involving lymphovascular invasion (LVI), pVM0, and endoscopically judged as negative horizontal margin. Additional esophagectomy (involving three-field lymphadenectomy), chemoradiotherapy [mainly cisplatin and 5-fluorouracil with concurrent radiotherapy (41.4 Gy)], or observation was undertaken. Thereafter, computed tomography was performed every 6–12 months. The cumulative recurrence (CRR) and recurrence-free survival (RFS) rates were evaluated. Results Eighty-nine patients were included. Among them, 14 had pathologically diagnosed pMM with LVI; 9 and 6, and 32 and 28 patients had pSM1 and pSM2 without and with LVI. Twenty-one patients underwent observation, whereas 18 and 50 underwent esophagectomy and chemoradiotherapy. During the 60.6-month median follow-up period, nine patients had recurrence; among them, six patients had occurrence at > 4 years after ER. The 5-year CRR/RFS rates were 35.7%/48.1%, 13.4%/80.4%, and 0.0%/98.0% in the observation, esophagectomy, and chemoradiotherapy groups, respectively (observation vs. chemoradiotherapy; P  < 0.001). Conclusions Additional treatments showed better long-term outcomes than observation for patients with NCR. As recurrence may occur at > 4 years after ER, careful long-term follow-up examinations are needed.
Usefulness of endoscopic ultrasound in predicting treatment efficacy of salvage endoscopic therapy for local failure after chemoradiotherapy for esophageal squamous cell carcinoma
BackgroundSalvage endoscopic therapy, including endoscopic resection (ER) and photodynamic therapy (PDT), is effective for esophageal squamous cell carcinoma (ESCC) in local failure after chemoradiotherapy (CRT). Resection with pathologically vertical margin-negative (VM0) for ER and local complete response (L-CR) for PDT are important surrogate prognostic markers for each therapy’s efficacy. We aimed to evaluate the usefulness of endoscopic ultrasound (EUS) in predicting the efficacy of salvage endoscopic therapy in local failure after CRT for ESCC.MethodsWe included patients who underwent EUS followed by ER or PDT for local failure after CRT or radiotherapy for ESCC from 2006 to 2020. We evaluated EUS findings associated with VM0 resection for ER and L-CR for PDT, which included the status of the outermost part of the submucosal layer, tumor thickness, and tumor invasion length into the muscularis propria (MP) layer.ResultsThirty and 47 patients were enrolled into the ER and PDT groups, respectively. The VM0 resection rate in the ER group was 87% (26/30). The EUS findings associated with VM0 resection were tumor thickness < 2.3 mm (p = 0.01) and preserved hyperechoic line of the outermost part of the submucosa layer (p < 0.01). The L-CR rate in the PDT group was 69% (32/47). The EUS findings associated with L-CR were tumor thickness < 5.0 mm (p < 0.01) and tumor invasion length into the MP layer < 1.6 mm (p = 0.03).ConclusionsEUS can be useful in predicting the efficacy of salvage endoscopic treatment for local failure after CRT for ESCC.
Impact of advanced endoscopy training on colonoscopy quality and efficiency
Objectives Few reports have detailed improvements in the quality of colonoscopies with continuous training post‐fellowship completion. We examined the changes in colonoscopy performance among trainees during our advanced endoscopy training program. Methods Screening or surveillance colonoscopies performed by 11 trainees who participated in our 3‐year advanced endoscopy training program between April 2015 and March 2020 were retrospectively analyzed. Quality and efficiency metrics of colonoscopies were evaluated annually. Results Altogether, 297, 385, and 438 colonoscopies were enrolled in the first, second, and third training years, respectively. The mean insertion times were 8.6, 7.6, and 6.9 min in the first, second, and third training years, respectively, with significant improvement from the first to second year (p = 0.03) and from the first to third year (p < 0.01). The adenoma detection rate, proximal adenoma detection rate, and mean number of adenomas per patient exhibited a tendency to improve annually; however, the difference was not significant. Polypectomy efficiency was 10.5%, 11.2%, and 13.0%, with significant improvements from the first to third year (p < 0.01) and from the second to third year (p = 0.02). Insertion time and polypectomy efficiency showed significant improvements, especially among trainees experienced with <500 colonoscopies. Conclusions Through our advanced endoscopy training program, there has been an improvement in the quality and efficiency of colonoscopy for trainees who have completed their fellowships, particularly those with <500 colonoscopies.
Definitive chemoradiotherapy has comparable survival outcomes to esophagectomy in patients with clinical T1N0M0 esophageal squamous cell carcinoma: real-world data
BackgroundRecently, the JCOG0502 has shown a comparable efficacy of chemoradiotherapy and esophagectomy in patients with clinical T1N0M0 esophageal squamous cell carcinoma. However, few studies have compared the clinical outcomes of these treatments in esophageal squamous cell carcinoma patients (including elderly patients) based on real-world data.MethodsThis retrospective study determined real-world outcomes in patients who underwent chemoradiotherapy or esophagectomy, including those with clinical T1N0M0 esophageal squamous cell carcinoma, between 2009 and 2017 at the National Cancer Center Hospital East.ResultsAmong a total of 156 patients, 120 and 36 patients underwent esophagectomy and chemoradiotherapy, respectively; 138, 12 and 6 patients had Eastern Cooperative Oncology Group performance status 0, 1, and 2, respectively; and 33 and 123 patients had clinical tumor depth MM-SM1 and SM2-SM3, respectively. In a median follow-up of 72 months, 5-year progression-free survival and overall survival were respectively 77.0% and 81.5% in the esophagectomy group and 74.4% and 82.6% in the chemoradiotherapy group (P = 0.48 and, P = 0.89). Moreover, no treatment-related death was detected in both groups. In elderly patients (75 years or older), 5-year progression-free survival and overall survival were not significantly different between esophagectomy and chemoradiotherapy groups (5-year progression-free survival: 72.3% vs. 81.8%, P = 0.38; 5-year overall survival: 76.9% vs. 81.8%, P = 0.59).ConclusionsThis real-world study confirms the results of a previous clinical trial, and the present findings support chemoradiotherapy as one of the standard treatment options in patients of all ages with clinical T1N0M0 esophageal squamous cell carcinoma.