Publications by authors named "Masataka Taguri"

219 Publications

Safety and efficacy of water pressure endoscopic submucosal dissection for colorectal tumors with submucosal fibrosis (with video).

Gastrointest Endosc 2021 Mar 30. Epub 2021 Mar 30.

Department of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

Background And Aims: Colorectal neoplasms with submucosal fibrosis are the most challenging targets of endoscopic resection. Water pressure endoscopic submucosal dissection (WP-ESD) is a recently introduced procedure that has several advantages over conventional endoscopic submucosal dissection (C-ESD). This study aimed to assess the efficacy and safety of WP-ESD for fibrotic colorectal neoplasms.

Methods: This retrospective observational study investigated 133 colorectal neoplasms expected to have submucosal fibrosis, which were resected by WP-ESD or C-ESD between April 2012 and April 2020. Eighty-seven lesions after endoscopic or surgical treatment, 18 with biopsy scar with fold convergence, and 28 in patients with ulcerative colitis were included. The differences in treatment outcomes, including procedure time and adverse events proportions, between the WP-ESD and C-ESD groups were analyzed. Clinical courses after perforation using WP-ESD were also evaluated, including postprocedural multidetector computed tomography (MDCT) findings obtained immediately after WP-ESD.

Results: Severe submucosal fibrosis was observed in 96 lesions (72.2%). The median procedure time was significantly shorter in the WP-ESD than in the C-ESD group (43.5 minutes [Interquartile range (IQR) 32.8-73] vs 72 minutes [IQR 45-105]; P =.0041). The multivariate analysis revealed WP-ESD as an independent factor for a short procedure time (odds ratio 2.90; 95% confidence interval 1.28-6.55). The proportions of post-ESD electrocoagulation syndrome (PEECS) (11.6% vs 13.1%) and perforation (20.4% vs 22.8%) were similar between the groups. Four of 11 patients with perforation using WP-ESD showed fluid collection on postprocedural MDCT images.

Conclusions: WP-ESD can shorten procedure time for treating fibrotic colorectal neoplasms.
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http://dx.doi.org/10.1016/j.gie.2021.03.026DOI Listing
March 2021

Pathogenic variants associated with VEXAS syndrome in Japanese patients with relapsing polychondritis.

Ann Rheum Dis 2021 Mar 31. Epub 2021 Mar 31.

Department of Human Genetics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

Objectives: To determine clinical and genetic features of individuals with relapsing polychondritis (RP) likely caused by pathogenic somatic variants in ubiquitin-like modifier activating enzyme 1 ().

Methods: Fourteen patients with RP who met the Damiani and Levine criteria were recruited (12 men, 2 women; median onset age (IQR) 72.1 years (67.1-78.0)). Sanger sequencing of was performed using genomic DNA from peripheral blood leukocytes or bone marrow tissue. Droplet digital PCR (ddPCR) and peptide nucleic acid (PNA)-clamping PCR were used to detect low-prevalence somatic variants. Clinical features of the patients were investigated retrospectively.

Results: was examined in 13 of the 14 patients; 73% (8/11) of the male patients had somatic variants (c.121A>C, c.121A>G or c.122T>C resulting in p.Met41Leu, p.Met41Val or p.Met41Thr, respectively). All the variant-positive patients had systemic symptoms, including a significantly high prevalence of skin lesions. ddPCR detected low prevalence (0.14%) of somatic variant (c.121A>C) in one female patient, which was subsequently confirmed by PNA-clamping PCR.

Conclusions: Genetic screening for pathogenic variants should be considered in patients with RP, especially male patients with skin lesions. The somatic variant in in the female patient is the first to be reported.
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http://dx.doi.org/10.1136/annrheumdis-2021-220089DOI Listing
March 2021

Incidence and predictors of prosthesis-patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve.

Open Heart 2021 03;8(1)

Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.

Background: The balloon-expandable SAPIEN 3 (S3) is superior to the older-generation balloon-expandable SAPIEN XT (XT) in a lower incidence of paravalvular aortic regurgitation, lower complication rates and better survival in transcatheter aortic valve implantation (TAVI). However, prosthesis-patient mismatch (PPM) more frequently occurs in S3 than XT. Further, little information is available on PPM after TAVI using S3 in Asians. This study aims to determine the incidence and predictors of PPM in S3 by focusing on the difference between S3 and XT using data from a Japanese multicentre registry.

Methods: From the Optimised transCathEter vAlvular iNtervention-TAVI (OCEAN-TAVI) registry, 2134 patients undergoing TAVI using S3 or XT were included. PPM was defined as moderate if ≧0.65 but ≦0.85 cm/m or severe if <0.65 cm/m at the indexed effective orifice area by postprocedural echocardiography.

Results: The incidence of moderate and severe PPM in S3 was 13.3% and 1.3%, respectively. The 20 mm transcatheter heart valve (THV) was more frequently used in S3 than XT (7.4% vs 2.4%, p<0.0001). PPM was more frequently observed in S3 than XT (14.7% vs 8.8%, p<0.0001). Multivariate logistic regression analysis revealed S3 predicted PPM (OR 1.92 (95% CI 1.35 to 2.74), p=0.0003). The mutual predictors for PPM between S3 and XT were younger age, larger body surface area, smaller aortic valve area, no balloon postdilatation and the use of 20 mm and 23 mm THV. When comparing 23 mm, 26 mm and 29 mm S3, the ORs of 20 mm S3 were 5.67 (95% CI 2.88 to 11.12), 19.24 (95% CI 8.13 to 46.86) and 51.03 (95% CI 12.28 to 280.77), respectively.

Conclusions: The incidence of PPM after TAVI using S3 was 14.6% overall in this Asian population. PPM was more frequently observed in S3 than XT. A considerable number of patients were treated by the 20 mm S3 in an Asian cohort. The 20 mm THV was identified as a strong predictor for PPM.
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http://dx.doi.org/10.1136/openhrt-2020-001531DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7978259PMC
March 2021

Comparing the effects of tofogliflozin and pioglitazone in non-alcoholic fatty liver disease patients with type 2 diabetes mellitus (ToPiND study): a randomized prospective open-label controlled trial.

BMJ Open Diabetes Res Care 2021 Feb;9(1)

Department of Gastroenterology and Hepatology, Yokohama City University, Yokohama, Japan.

Introduction: The treatment of diabetes has a significant impact on the pathogenesis of non-alcoholic fatty liver disease (NAFLD). We compared the effectiveness of tofogliflozin, a selective sodium-glucose cotransporter 2 inhibitor, and pioglitazone for the treatment of NAFLD patients with type 2 diabetes mellitus.

Research Design And Methods: This open-label, prospective, single-center, randomized clinical trial recruited NAFLD patients with type 2 diabetes mellitus and a hepatic fat fraction of at least 10% as assessed based on the MRI-proton density fat fraction (MRI-PDFF). Eligible patients were stratified according to hemoglobin A1c (HbA1c), alanine transaminase, and MRI-PDFF levels and randomly assigned (1:1) to receive either 20 mg tofogliflozin or 15-30 mg pioglitazone, orally, once daily for 24 weeks. The primary endpoint was an absolute change in MRI-PDFF at 24 weeks. Efficacy and safety was assessed in all treated patients. This trial was registered in the Japan Registry of Clinical Trials.

Results: Overall, 40 eligible patients were randomly assigned to receive tofogliflozin (n=21) or pioglitazone (n=19). Changes in hepatic steatosis after 24 weeks of treatment were evaluated by MRI-PDFF, which showed a significant decrease in both groups (-7.54% (p<0.0001) and -4.12% (p=0.0042) in the pioglitazone and tofogliflozin groups, respectively). Compared with baseline, the body weight decreased by 2.83±2.86 kg (-3.6%, p=0.0443) in the tofogliflozin group and increased by 1.39±2.62 kg (1.7%, p=0.0002) in the pioglitazone group after 24 weeks. No life-threatening events or treatment-related deaths occurred.

Conclusions: Tofogliflozin was well tolerated, and it reduced the MRI-PDFF levels in NAFLD patients with type 2 diabetes mellitus.

Trial Registration Number: jRCTs031180159.
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http://dx.doi.org/10.1136/bmjdrc-2020-001990DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7888333PMC
February 2021

Effectiveness of entecavir in preventing hepatocellular carcinoma development is genotype-dependent in hepatitis B virus-associated liver cirrhosis.

World J Hepatol 2021 Jan;13(1):144-150

Division of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan.

Background: The oral nucleos(t)ide analogue, entecavir (ETV) was demonstrated to reduce the rate of hepatocellular carcinoma (HCC) in patients with hepatitis B virus (HBV)-associated liver cirrhosis. However, the reduction of HCC differs in various regions of the world.

Aim: To investigate the reduction of HCC development due to ETV therapy by meta-analysis.

Methods: We surveyed the differences in HCC development following ETV treatment based on published articles using PubMed (2004-2019).

Results: The regions with the most marked reduction in HCC development due to ETV therapy were Spain (1.0%/year) and Canada (Southern part, 1.3%/year), and the most ineffective areas were South Korea (3.6%-3.8%/year), China (3.3%/year), Taiwan (2.4%-3.1%/year), and Hong Kong (2.8%/year). Following ETV administration, the incidence of HCC in genotype D regions (1.89% ± 0.28%/year, mean ± SE) was significantly lower than that in genotype C regions (2.91% ± 0.24%/year, < 0.01). With regard to the initial HBV-DNA level, in genotype C patients (average: 5.61 LogIU/mL) this was almost the same as that in genotype D patients (average: 5.46 LogIU/mL). Moreover, there was no association between the prevalence ratio of HBV and the incidence of HCC on ETV treatment.

Conclusion: The effectiveness of ETV in preventing HCC development in HBV-associated liver cirrhosis is genotype-dependent.
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http://dx.doi.org/10.4254/wjh.v13.i1.144DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856867PMC
January 2021

Short-Term Outcomes from a Randomized Screening Phase II Non-inferiority Trial Comparing Omentectomy and Omentum Preservation for Locally Advanced Gastric Cancer: the TOP-G Trial.

World J Surg 2021 Jun 10;45(6):1803-1811. Epub 2021 Feb 10.

Department of Surgery, Fujisawa Shonandai Hospital, Fujisawa, Japan.

Background: Omentectomy is considered an essential part of curative gastrectomy for locally advanced gastric cancer (GC), albeit without solid evidence. We conducted a randomized phase II trial (the TOP-G trial) comparing omentectomy and omentum preservation for gastric cancer. This report describes the short-term findings regarding the trial's secondary endpoints.

Methods: The trial protocol was submitted to the University Hospital Medical Information Network Clinical Trials Registry ( http://www.umin.ac.jp/ctr/ : UMIN000005421). The key eligibility criteria were histologically confirmed cT2-4a and N0-2 gastric adenocarcinoma. Short-term surgical outcomes, including morbidity and mortality, were compared between the omentectomy group (group A, control arm) and the omentum-preserving surgery group (group B, test arm). All procedures were performed via an open approach. Based on a non-inferiority margin of 7%, statistical power of 0.7, and type I error of 0.2, the sample size was set to 250 patients.

Results: A total of 251 patients were eligible and randomized (group A: 125 patients, group B: 126 patients) between April 2011 and October 2018. After excluding patients who had peritoneal metastasis or laparotomy history, safety outcomes were analyzed for 247 patients. Group A had a significantly longer median operation time (225 min vs. 204 min, p = 0.022) and tended to have greater median blood loss (260 mL vs. 210 mL p = 0.073). The incidences of morbidity were similar and < 10% in both groups (8% vs. 9%, p = 1.000). There was no mortality in either group.

Conclusions: Operative risk was generally similar between omentectomy and omentum-preserving surgery for locally advanced gastric cancer.
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http://dx.doi.org/10.1007/s00268-021-05988-7DOI Listing
June 2021

Biodistribution and radiation dosimetry of the positron emission tomography probe for AMPA receptor, [C]K-2, in healthy human subjects.

Sci Rep 2021 Jan 15;11(1):1598. Epub 2021 Jan 15.

Department of Physiology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

[C]K-2, a radiotracer exhibiting high affinity and selectivity for α-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptors (AMPARs), is suitable for the quantification of AMPARs in living human brains and potentially useful in the identification of epileptogenic foci in patients. This study aimed to estimate the radiation doses of [C]K-2 in various organs and calculate the effective dose after injection of [C]K-2 in healthy human subjects. Twelve healthy male subjects were registered and divided into two groups (370 or 555 MBq of [C]K-2), followed by 2 h whole-body scans. We estimated the radiation dose of each organ and then calculated the effective dose for each subject. The highest uptake of [C]K-2 was observed in the liver, while the brain also showed relatively high uptake. The urinary bladder exhibited the highest radiation dose. The kidneys and liver also showed high radiation doses after [C]K-2 injections. The effective dose of [C]K-2 ranged from 5.0 to 5.2 μSv/MBq. Our findings suggest that [C]K-2 is safe in terms of the radiation dose and adverse effects. The injection of 370-555 MBq (10 to 15 mCi) for PET studies using this radiotracer is applicable in healthy human subjects and enables serial PET scans in a single subject.
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http://dx.doi.org/10.1038/s41598-021-81002-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7810729PMC
January 2021

Randomized Phase II Study of Gemcitabine Monotherapy vs. Gemcitabine with an EPA-Enriched Oral Supplement in Advanced Pancreatic Cancer.

Nutr Cancer 2021 Jan 13:1-10. Epub 2021 Jan 13.

Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan.

Background: Pancreatic cancer is often associated with cachexia. It had been reported that eicosapentaenoic acid (EPA) improve cachexia. This study aimed to evaluate the efficacy and safety of gemcitabine with an EPA-enriched oral supplement in patients with advanced pancreatic cancer.

Methods: This open-label phase II study consisted of patients (pts) who were randomly categorized into the EPA group (1,000 mg/m gemcitabine was administered on day 1, 8, and 15, every 4 weeks while an EPA-enriched oral supplement (prosure®, EPA 1.056 mg per pack) was taken daily at the maximum of two packs or the gemcitabine monotherapy group with an allocation ratio of 2:1. The primary endpoint was the evaluation of the 1-year survival estimating 10% addition.

Results: Randomized 68 pts were examined (EPA: 45, gemcitabine: 23). The 1-year survival probability of the EPA group was 35% while the gemcitabine group was 19%. The median survival times were 8.2 and 9.7 mo, respectively. The hazard ratio for EPA group was 0.79 [95% CI 0.46-1.37]; ( = 0.40). The toxicities were mild and insignificant in both groups. More beneficial effects of EPA in survival were observed in men, pancreatic body-tail and low C-reactive protein patients.

Conclusion: An EPA-enriched oral supplement may be effective in advanced pancreatic cancer.
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http://dx.doi.org/10.1080/01635581.2020.1871495DOI Listing
January 2021

Long-term clinical effectiveness of a drug-coated balloon for in-stent restenosis in Femoropopliteal lesions.

CVIR Endovasc 2021 Jan 11;4(1):13. Epub 2021 Jan 11.

Department of Cardiovascular Medicine, Sendai Kousei Hospital, 4-15 Hirose-cho, Aoba-ku, Sendai, Miyagi, 980-0873, Japan.

Background: The short-term efficacy of paclitaxel-coated balloons (PCBs) has been established in femoropopliteal in-stent restenosis (ISR) lesions. The aim of this study was to compare 5-year clinical outcomes of patients with femoropopliteal ISR lesions undergoing percutaneous transluminal angioplasty (PTA) with and without PCB.

Methods: After 1:1 propensity score matching, we extracted 50 patients with femoropopliteal ISR lesions undergoing PTA with (n = 25) and without (n = 25) IN.PACT PCB (Medtronic, Minneapolis, MN) from 106 consecutive ISR patients treated in our hospital between 2009 and 2015. We compared the 5-year outcomes between PCB and non-PCB groups. The primary endpoint was the cumulative 5-year incidence of recurrent restenosis. All-cause mortality, target lesion revascularization (TLR) and unplanned major amputation were also assessed.

Results: The primary patency after PCB treatment at 5 years was significantly higher than the patency after non-PCB treatment (65.7% vs. 18.7%; hazard ratio [HR]: 6.11; 95% confidence intervals [CI]: 2.57-16.82; p < 0.001), as well as freedom from TLR (77.6% vs. 53.8%; HR: 3.55; 95% CI: 1.21-12.83; p = 0.020). All-cause mortality and unplanned major amputation rates did not significantly differ between the two groups. The Cox proportional hazard multivariate analysis showed that PCB was independently associated with preventing recurrent restenosis (HR: 0.17; 95% CI: 0.06-0.41; p < 0.001).

Conclusions: At 5 years, patients with femoropopliteal ISR lesions undergoing PCB treatment showed significantly lower recurrent restenosis than those that underwent non-PCB treatment.

Evidence-based Medicine: Level of Evidence: Level 2b, Non-randomized controlled cohort/follow-up study.
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http://dx.doi.org/10.1186/s42155-021-00205-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801575PMC
January 2021

Appropriate endoscopic treatment selection and surveillance for superficial non-ampullary duodenal epithelial tumors.

Scand J Gastroenterol 2021 Mar 31;56(3):342-350. Epub 2020 Dec 31.

Department of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

Objectives: Superficial nonampullary duodenal epithelial tumors (SNADETs) have become frequently detected and referred for endoscopic resection (ER). However, optimal treatment methods and long-term outcomes after ER of SNADETs have not been fully elucidated. We aimed to clarify them by analyzing our large cohort of patients with SNADETs.

Materials And Methods: We enrolled 190 consecutive tumors from 189 patients undergoing ER between January 2004 and September 2019. Cases were stratified into endoscopic submucosal dissection (ESD), conventional endoscopic mucosal resection, (CEMR) and underwater endoscopic mucosal resection (UEMR). Baseline characteristics and short-term outcomes were compared between the groups. Long-term outcomes were also investigated with a median follow-up of 36 months.

Results: ESD significantly exceeded CEMR (96.4% vs. 52.9%;  = .0026) and UEMR (96.4% vs. 50.0%;  = .0008) in complete resection rates for 11- to 20-mm lesions; the differences were not significant for lesions ≤10 mm. Local recurrence only occurred in patients with an incomplete resection. Only patients with submucosal invasion died from the primary neoplasms. The 3- and 5-year disease-free survivals were 91.3% and 83.5%.

Conclusions: While tumors ≤10 mm seem to be good indications for endoscopic mucosal resection, ESD should be considered for larger tumors to better achieve complete resection. Patients with submucosal invasive carcinomas have a great risk of cancer death. Therefore, a close follow-up and an additional treatment are desirable.
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http://dx.doi.org/10.1080/00365521.2020.1867896DOI Listing
March 2021

Relationship between Programmed Cell Death Protein Ligand 1 Expression and Immune-related Adverse Events in Non-small-cell Lung Cancer Patients Treated with Pembrolizumab.

JMA J 2020 Jan 8;3(1):58-66. Epub 2019 Nov 8.

Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.

Introduction: Immune checkpoint inhibitors (ICIs) can lead to immune-related adverse events (irAEs). A correlation between the development of irAEs and efficacy has been suggested; however, it is unclear whether there is a relationship between programmed death ligand 1 (PD-L1) expression and the development of these events.

Methods: We performed a retrospective study of advanced or metastatic non-small cell lung cancer (NSCLC) patients who were treated with pembrolizumab monotherapy at our institution between May 2015 and April 2018 (n = 44). Patients were categorized into two groups, specifically those with irAEs (irAE group) or without (non-irAE group), and we evaluated the objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Predictors of irAEs were examined by multivariate analysis.

Results: irAEs of any grade occurred in 31 (70.5%) patients. The median PFS was 10.9 months in the irAE group versus 3.7 months in the non-irAE group ( < 0.001). ORR and DCR were also higher in the irAE group than in the non-irAE group. Furthermore, high PD-L1 expression (≥50%) was a predictive factor of irAE based on logistic regression ( = 0.004).

Conclusions: In patients with advanced NSCLC treated with pembrolizumab monotherapy, ORR, DCR, and PFS were significantly better in the irAE group than in the non-irAE group. High PD-L1 expression, at the time of pretreatment, was identified as an independent predictor of irAE development. We believe that more careful management of irAEs for individuals with high PD-L1 expression is needed to improve clinical benefits. Further, PD-L1 expression might be useful for ICI risk management.
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http://dx.doi.org/10.31662/jmaj.2019-0005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7733761PMC
January 2020

Patients' characteristics and mortality in urgent/emergent/salvage transcatheter aortic valve replacement: insight from the OCEAN-TAVI registry.

Open Heart 2020 12;7(2)

Cardiology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.

Objectives: Patients' backgrounds and clinical outcomes in urgent/emergent/salvage transcatheter aortic valve replacement (Em-TAVR) remain unclear. We investigated patient characteristics and the mortality in Em-TAVR and the predictors for the need for Em-TAVR.

Methods: We consecutively enrolled 1613 patients undergoing TAVR for severe aortic stenosis between October 2013 and July 2016 from the Optimised transCathEter vAlvular interventioN (OCEAN)-transcatheter aortic valve implantation (TAVI) registry. The urgency was based on the European System for Cardiac Operative Risk Evaluation II. Urgent, emergent or salvage were included with the Em-TAVR group and elective with the El-TAVR group.

Results: Em-TAVR was observed in 87 (5.4%) patients. A higher Clinical Frailty Scale (CFS), peripheral artery disease (PAD), hypoalbuminaemia, reduced left ventricular ejection fraction (LVEF) and preoperative at least moderate mitral regurgitation (MR) predicted the need for the Em-TAVR by the multivariate logistic regression analysis. The Em-TAVR group had the higher Society of Thoracic Surgeons Score (13.7 (IQR 8.2-21.0) vs 6.5 (IQR 4.6-9.2); p<0.001) and higher 30-day mortality (9.2% vs 1.3%; p<0.001) than the El-TAVR group. Accordingly, Kaplan-Meier analysis showed that the cumulative mortality was higher in the Em-TAVR group than that in the El-TAVR group (log-rank; p<0.001). However, Em-TAVR did not predict mortality in the multivariate Cox regression analysis.

Conclusions: Em-TAVR was performed in 5.4% of patients. Higher CFS, PAD, hypoalbuminaemia, reduced LVEF and preprocedural MR predicted the need for Em-TAVR. Em-TAVR was not a predictor for mortality in the multivariate analysis, suggesting that it is a reasonable treatment option.
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http://dx.doi.org/10.1136/openhrt-2020-001467DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737081PMC
December 2020

Real impact of tumor marker AFP and PIVKA-II in detecting very small hepatocellular carcinoma (≤ 2 cm, Barcelona stage 0) - assessment with large number of cases.

World J Hepatol 2020 Nov;12(11):1046-1054

Department of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan.

Background: In hepatocellular carcinoma (HCC), detection and treatment prior to growth beyond 2 cm are relevant as a larger tumor size is more frequently associated with microvascular invasion and/or satellites.

Aim: To examine the impact of the tumor marker alpha-fetoprotein (AFP) or PIVKA-II in detecting very small HCC nodules (≤ 2 cm in maximum diameter, Barcelona stage 0) in the large number of very small HCC. The difference in the behavior of these tumor markers in HCC development was also examined.

Methods: A total of 933 patients with single-nodule HCC were examined. They were subdivided into 394 patients with HCC nodules ≤ 2 cm in maximum diameter and 539 patients whose nodules were > 2 cm. The rates of patients whose AFP and PIVKA-II showed normal values were examined.

Results: The positive ratio of the marker PIVKA-II was significantly different ( < 0.0001) between patients with nodules ≤ 2 cm in diameter and those with nodules > 2 cm, but there was no significant difference in AFP ( = 0.4254). In the patients whose tumor was ≤ 2 cm, 50.5% showed normal levels in AFP and 68.8% showed normal levels in PIVKA-II. In 36.4% of those patients, both AFP and PIVKA-II showed normal levels. The PIVKA-II-positive ratio was markedly increased with an increase in the tumor size. In contrast, the positivity in AFP was increased gradually and slowly.

Conclusion: In the surveillance of very small HCC nodules (≤ 2 cm in diameter, Barcelona clinical stage 0) the tumor markers AFP and PIVKA-II are not so useful.
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http://dx.doi.org/10.4254/wjh.v12.i11.1046DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7701964PMC
November 2020

Third-look endoscopy prevents delayed bleeding after endoscopic submucosal dissection under antithrombotic therapy.

World J Gastroenterol 2020 Nov;26(41):6475-6487

Division of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan.

Background: Postoperative delayed bleeding (PDB) after gastric endoscopic submucosal dissection (ESD) is the most common adverse event in patients receiving antithrombotics even with second-look endoscopy. Moreover, with the increasing prevalence of cardiovascular and cerebrovascular diseases in an aging population with associated lifestyle-related diseases, an increasing number of patients receive antithrombotics. Several attempts have been made to prevent PDB in aging population; however, a consensus has yet to be reached.

Aim: To examine the efficacy of third-look endoscopy (TLE) for PDB prevention.

Methods: One hundred patients with early gastric neoplasms receiving antithrombotics were prospectively enrolled and subjected to ESD with TLE between February 2017 and July 2019. The primary endpoint was PDB rate, which was compared with our preset threshold. Furthermore, we divided the bleeding period into early-and late-onset PDB (E-PDB and L-PDB, respectively) and analyzed its rate. As a secondary analysis, we compared PDB rates with those of a historical control group, using propensity score matching, and calculated the PDB rates per antithrombotic agent use in each group.

Results: In total, 96 patients and 114 specimens were finally evaluated. The overall PDB rate was 7.9% (9/114) [90%CI: 4.7-13.1, = 0.005], while the late-and early-onset PDB rates (L-PDB and E-PDB) were 5.3% [90%CI: 2.7-9.9, < 0.0001] and 2.6% [90%CI: 1.1-6.4, = 0.51], respectively. Propensity score matching generated 58 matched pairs for TLE and control groups. No differences were found in overall PDB incidence (10.3% 20.7%, = 0.12), whereas L-PDB occurrence significantly differed (5.2% 17.2%, = 0.04) between groups. Considering antithrombotics' use, the overall PDB rate was higher for direct oral anticoagulants and multiple antithrombotics in the control group, while L-PDB incidence was lower in the TLE group for these agents (8.7% 23.1% and 5.0% 29.4%, respectively).

Conclusion: TLE for gastric ESD reduces overall PDB, and especially L-PDB incidence, among patients receiving antithrombotics.
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http://dx.doi.org/10.3748/wjg.v26.i41.6475DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7656207PMC
November 2020

Erratum to "Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices".

J Interv Cardiol 2020 22;2020:1303764. Epub 2020 Oct 22.

Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.

[This corrects the article DOI: 10.1155/2020/8216831.].
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http://dx.doi.org/10.1155/2020/1303764DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7603606PMC
October 2020

Serum surfactant protein A as a surrogate biomarker of a negative heart sign among patients with interstitial lung disease.

Nagoya J Med Sci 2020 Aug;82(3):499-508

Division of Infectious Diseases and Respiratory Medicine, Department of Internal Medicine, National Defense Medical College, Saitama, Japan.

The mechanisms underlying interstitial lung disease (ILD) are characterized by variable inflammation or fibrosis of the pulmonary interstitium. A negative heart sign (NHS) on Ga scintigrams of patients with ILD is due to considerably increased inflammatory activity in the lungs. We retrospectively analyzed relationships between NHS and established biomarkers of disease severity in patients with ILD. Among 81 consecutive non-smoking patients with ILD (mean age, 63 years) who had been hospitalized between April 2009 and October 2011, we selected 52 who had been assessed by Ga scintigraphy. We then evaluated relationships between NHS and blood biomarkers, pulmonary function and high-resolution computed tomography (HRCT). Among these 52 patients, 10 showed idiopathic pulmonary fibrosis and 42 had other ILD. Multivariate analysis with stepwise variable selection, serum surfactant protein (SP)-A (OR (odds ratio), 1.026; 95%CI (confidence interval), 1.003-1.050; P = 0.024) and inflammation index calculated from HRCT findings (OR, 1.358; 95%CI, 1.079-1.709; P = 0.009) were significant predictors of an NHS. Serum SP-A offered 85% sensitivity and 75% specificity for predicting NHS at an optimal cut-off of 45.8 ng/mL. Serum SP-A concentrations correlated positively with inflammation index (r = 0.344, P = 0.015). In conclusion, serum SP-A might serve as a surrogate biomarker for predicting an NHS in patients with ILD.
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http://dx.doi.org/10.18999/nagjms.82.3.499DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7548256PMC
August 2020

De novo variants in CELF2 that disrupt the nuclear localization signal cause developmental and epileptic encephalopathy.

Hum Mutat 2021 Jan 10;42(1):66-76. Epub 2020 Nov 10.

Department of Biochemistry, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.

We report heterozygous CELF2 (NM_006561.3) variants in five unrelated individuals: Individuals 1-4 exhibited developmental and epileptic encephalopathy (DEE) and Individual 5 had intellectual disability and autistic features. CELF2 encodes a nucleocytoplasmic shuttling RNA-binding protein that has multiple roles in RNA processing and is involved in the embryonic development of the central nervous system and heart. Whole-exome sequencing identified the following CELF2 variants: two missense variants [c.1558C>T:p.(Pro520Ser) in unrelated Individuals 1 and 2, and c.1516C>G:p.(Arg506Gly) in Individual 3], one frameshift variant in Individual 4 that removed the last amino acid of CELF2 c.1562dup:p.(Tyr521Ter), possibly resulting in escape from nonsense-mediated mRNA decay (NMD), and one canonical splice site variant, c.272-1G>C in Individual 5, also probably leading to NMD. The identified variants in Individuals 1, 2, 4, and 5 were de novo, while the variant in Individual 3 was inherited from her mosaic mother. Notably, all identified variants, except for c.272-1G>C, were clustered within 20 amino acid residues of the C-terminus, which might be a nuclear localization signal. We demonstrated the extranuclear mislocalization of mutant CELF2 protein in cells transfected with mutant CELF2 complementary DNA plasmids. Our findings indicate that CELF2 variants that disrupt its nuclear localization are associated with DEE.
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http://dx.doi.org/10.1002/humu.24130DOI Listing
January 2021

Histopathological validation of magnifying endoscopy for diagnosis of mixed-histological-type early gastric cancer.

World J Gastroenterol 2020 Sep;26(36):5450-5462

Department of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan.

Background: The undifferentiated-type (UDT) component profoundly affects the clinical course of early gastric cancers (EGCs). However, an accurate preoperative diagnosis of the histological types is unsatisfactory. To date, few studies have investigated whether the UDT component within mixed-histological-type (MT) EGCs can be recognized preoperatively.

Aim: To clarify the histopathological characteristics of the endoscopically-resected MT EGCs for investigating whether the UDT component could be recognized preoperatively.

Methods: This was a single-center retrospective study. First, we attempted to clarify the histopathological characteristics of the endoscopically-resected MT EGCs with emphasis on the UDT component. Histopathological examination investigated each lesion's UDT component: (1) Whole mucosal layer occupation of the UDT component; (2) UDT component exposure to the surface of the mucosa; and (3) existence of a clear border between the differentiated-type and UDT components. Then, preoperative endoscopic images with magnifying endoscopy with narrow-band imaging (ME-NBI) were examined to identify whether the endoscopic UDT component finding was recognizable within the area where it was present in the histopathological examination. The preoperative biopsy results and comparative relationships between endoscopic and histopathological findings were also examined.

Results: In the histopathological examination, the whole mucosal layer occupation of the UDT component and exposure of the UDT component to the mucosal surface were observed in 67.3% (33/49) and 79.6% (39/49) of samples, respectively. A clear distinction of the border between the differentiated-type and UDT components could not be drawn in 65.3% (32/49) of MT lesions. In the endoscopic examination, the preoperative endoscopic images showed that only 24.5% (12/49) of MT EGCs revealed the UDT component within the area where it was present histopathologically. Histopathological UDT predominance was the single significant factor associated with the presence of the endoscopic UDT component finding (61.5% 11.1%, = 0.0009). Only 26.5% (13/49) of the lesions were diagnosed from the pretreatment biopsy as having a UDT component. Combined results of the pretreatment biopsy and ME-NBI showed the preoperative presence of the UDT component in 40.8% (20/49) of MT EGCs.

Conclusion: Recognition of a UDT component within MT EGCs is difficult even when pretreatment biopsy and ME-NBI are combined. Endoscopic resection plays a significant role in both treatment and diagnosis.
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http://dx.doi.org/10.3748/wjg.v26.i36.5450DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520603PMC
September 2020

Factors influencing interruption of colorectal endoscopic submucosal dissection.

Surg Endosc 2020 Oct 1. Epub 2020 Oct 1.

Department of Gastroenterology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.

Background And Aims: Although colorectal endoscopic submucosal dissection (ESD) has become a standardized procedure worldwide, the difficulty of the procedure is well known. However, there have been no studies assessing the causes of treatment interruption. The present study aimed to evaluate the factors involved in the interruption of colorectal ESD.

Methods: We retrospectively analyzed 1116 consecutive superficial colorectal neoplasms of 1012 patients who were treated with ESD between August 2008 and September 2018. The clinicopathological characteristics and treatment outcomes were analyzed.

Results: Interrupted ESD was reported in 14 lesions (1.3%) of the total study population. Univariate analysis of clinical characteristics indicated that age, 0-I macroscopic-type tumor, and tumor location on the left side colon were risk factors for interruption. Multivariate analysis revealed that 0-I macroscopic-type tumor was the sole preoperative independent risk factor for interruption. Univariate analysis revealed that the presence of muscle-retracting sign (MRS), deep submucosal tumor invasion, and intermediate invasive growth pattern represented the etiology of interruption. Multivariate analysis indicated that MRS can be a sole key sign for the interruption. Additionally, the resectability and curability of 0-I type tumors were significantly inferior to those of predominantly lateral spreading tumors. Observations of 0-I macroscopic-type tumors, MRS, and submucosal deep invasion were significantly more frequent in interrupted cases. Conventional endoscopic images without magnification endoscopy were more associated with interruption than irregular surfaces or Vi pit patterns in cases with 0-I type tumors.

Conclusion: ESD of 0-I type tumors is highly disruptive, and undiagnosable submucosal infiltration can reduce the curability.
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http://dx.doi.org/10.1007/s00464-020-08042-0DOI Listing
October 2020

Lack of a bridge between screening and medical management for hypertension: health screening cohort in Japan.

BMC Public Health 2020 Sep 17;20(1):1419. Epub 2020 Sep 17.

Department of Data Science, Yokohama City University School of Data Science, Yokohama, Japan.

Background: Patient journeys for hypertensive individuals after detection at screening have not been well examined in a general population. Thus, we aimed to assess the medical treatment status and subsequent longitudinal changes in blood pressure in a middle-aged Japanese population.

Methods: We conducted a cohort study using a nationwide Japanese health screening cohort, from April 2014 to March 2019. Among health screening participants aged 40-74 years who had not previously received treatment for hypertension, hypertensive patients were newly identified based on screening results, and their medical treatment status for hypertension during the year following their initial screening was assessed. The main outcomes were longitudinal changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 4 years after initial screening.

Results: Of the 153,523 screening participants (mean age = 49.7 years), 16,720 (10.9%) and 4150 (2.7%) were newly detected as having hypertension, with baseline SBP of 140-159 mmHg (grade 1) and ≥ 160 mmHg (grade 2-3), respectively. Among them, 15.9% of the grade 1 hypertensive participants and 36.3% of the grade 2-3 hypertensive participants started receiving medical treatment during the year following initial screening. A linear generalised estimating equation with propensity score matching showed that receiving medical treatment was associated with 5.77 mmHg lower SBP (95% CI - 6.64 to - 4.90) and 3.82 mmHg lower DBP (95% CI - 4.47 to - 3.16) in the grade 1 hypertensive group, and 14.69 mmHg lower SBP (95% CI - 16.35 to - 13.04) and 8.42 mmHg lower DBP (95% CI - 9.49 to - 7.34) in the grade 2-3 hypertensive group.

Conclusions: Health screenings detected hypertension in a substantial percentage of the middle-aged population in this study. However, detection was often followed by insufficient medical treatment and inappropriate blood pressure management. These findings indicate an inadequate link between health screenings and medical treatments in patients with hypertension.
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http://dx.doi.org/10.1186/s12889-020-09532-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499996PMC
September 2020

Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices.

J Interv Cardiol 2020 14;2020:8216831. Epub 2020 Aug 14.

Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.

A Glidesheath slender (Terumo, Tokyo, Japan) and a sheathless Eaucath guiding catheter (Asahi Intecc, Nagoya, Japan) are two major slender devices utilized in percutaneous coronary intervention (PCI). This study aimed to investigate the differences in access-site complications between these devices in PCI for acute coronary syndrome (ACS). A total of 1108 consecutive patients who underwent transradial PCI for ACS were enrolled. Transradial PCI was performed using either a 7-Fr Glidesheath slender/7-Fr guiding catheter combination (Glidesheath group) or a 7.5-Fr sheathless guiding catheter (Sheathless group); 1 : 1 propensity score matching was performed, and 728 patients (364 in each group) were included in the propensity-matched population. In the matched patients, univariate analysis revealed that the Glidesheath group had less radial artery occlusion (RAO) at 30 days (Glidesheath: 1.4% vs. Sheathless: 4.1%, odds ratio (OR) = 0.33, 95% confidence interval (CI) =  0.12-0.91, =0.039), whereas no significant between-group differences were observed in severe radial spasm (Glidesheath: 1.4% vs. Sheathless: 1.9%, OR = 0.71, 95% CI = 0.23-2.22, =0.58) or access-site major bleeding (Glidesheath: 1.4% vs. Sheathless: 1.6%, OR = 0.83, 95% CI = 0.26-2.71, =1.00). Multivariate analysis revealed that the choice for Glidesheath was significantly associated with less RAO (OR = 0.32, 95% CI = 0.11-0.93, =0.036). In conclusion, 7-Fr Glidesheath slender/7-Fr guiding catheter combination is obviously more advantageous than 7.5-Fr sheathless guiding catheters for decreased risk of RAO. The potential low risk of RAO in our findings supports the adoption of the 7-Fr Glidesheath slender sheath/7-Fr guiding catheter combination in transradial PCI for ACS.
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http://dx.doi.org/10.1155/2020/8216831DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443233PMC
January 2021

Lubiprostone in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled, phase 2a trial.

Lancet Gastroenterol Hepatol 2020 11 15;5(11):996-1007. Epub 2020 Aug 15.

Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. Electronic address:

Background: The laxative drug lubiprostone improves intestinal permeability in healthy volunteers. We aimed to assess efficacy and safety of lubiprostone in patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability.

Methods: This randomised, double-blind, placebo-controlled, phase 2a study in Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT) at least 40 U/L, liver stiffness (≤6·7 kPa), and hepatic fat fraction at least 5·2% when assessed by MRI-proton density fat fraction. Eligible patients were randomly assigned (11:10:9) by a computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo, orally, once per day for 12 weeks. The primary endpoint was the absolute changes in ALT at 12 weeks. Efficacy analysis was done by intention to treat. Safety was assessed in all treated patients. This trial was registered with University Hospital Medical Information Network Clinical Trials Registry (UMIN000026635).

Findings: Between March 24, 2017, and April 3, 2018, we screened 288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients were assigned to receive 24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo. A greater decrease in the absolute ALT levels from baseline to 12 weeks was seen in the 24 μg lubiprostone group (mean -13 U/L [SD 19]) than in the placebo group (1 U/L [24]; mean difference -15 U/L [95% CI -23 to -6], p=0·0007) and in the 12 μg lubiprostone group (-12 U/L [21]) than in the placebo group (mean difference -13 U/L [-22 to -5], p=0·0023). 18 (33%) of 55 patients in the 24 μg group had at least one adverse event, as did three (6%) of 47 patients in the 12 μg group and three (7%) of 43 in the placebo group. The most common adverse event was diarrhoea (17 [31%] of patients in the 24 μg group, three [6%] in the 12 μg group, none in the placebo group). No life-threatening events or treatment-related deaths occurred.

Interpretation: Lubiprostone was well tolerated and reduced the levels of liver enzymes in patients with NAFLD and constipation. Further studies are necessary to better define the efficacy and tolerability of lubiprostone in patients with NAFLD without constipation.

Funding: Mylan EPD G.K.
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http://dx.doi.org/10.1016/S2468-1253(20)30216-8DOI Listing
November 2020

Mixed histology poses a greater risk for noncurative endoscopic resection in early gastric cancers regardless of the predominant histologic types.

Eur J Gastroenterol Hepatol 2021 Feb;32(2):186-193

Department of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

Objectives: Clinicopathologic characteristics and treatment outcomes of mixed-histological-type (MT) early gastric cancers (EGCs) treated with endoscopic submucosal dissection (ESD) have not been sufficiently elucidated. We aimed to clarify them in comparison with pure-histological-type EGCs.

Methods: We used 3022 consecutive EGCs in 2281 patients treated with ESD from our prospectively maintained database. Cases were stratified into four groups according to the final diagnosis of the resected specimen are as follows: 2780 pure differentiated-type (DT), 127 DT-predominant MT (D-MT), 87 pure undifferentiated-type (UDT), and 28 UDT-predominant MT (U-MT). Clinicopathologic characteristics and treatment outcome were compared between pure DT and D-MT, and between pure UDT and U-MT separately. Risk factors for deep submucosal invasion, lymphovascular invasion, and a final diagnosis of MT were identified using multivariate analysis.

Results: Both D-MT (41.7 vs. 92.0%; P < 0.0001) and U-MT (35.7 vs. 75.9%; P = 0.0002) showed a significantly lower curative resection rate than their pure histologic counterparts. Multivariate analysis revealed that MT was an independent risk factor for deep submucosal (OR 6.55; 95% CI, 4.18-10.14) and lymphovascular (OR 4.74; 95% CI, 2.72-8.29) invasion. Preoperative biopsy results that did not show well-differentiated tubular adenocarcinoma (OR 28.2; 95% CI, 18.9-42.9) were an independent risk factor for a final diagnosis of MT.

Conclusions: MT poses a greater risk for noncurative resection regardless of the predominant histologic types, reflecting more aggressive malignant potential. Although a biopsy examination rarely shows MT, clinicians should consider the possibility of MT when a biopsy examination does not show well-differentiated tubular adenocarcinoma.
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http://dx.doi.org/10.1097/MEG.0000000000001894DOI Listing
February 2021

Predictors of the need for supportive femoral approach during transvenous extraction of pacemaker and defibrillator leads in Japanese patients.

J Arrhythm 2020 Aug 3;36(4):746-754. Epub 2020 Jul 3.

Department of Data Science Yokohama City University School of Data Science Yokohama Japan.

Background: Studies on femoral approach during transvenous lead extraction (TLE) are limited.

Methods: We retrospectively evaluated 75 patients undergoing TLE from September 2014 through November 2019 via supportive femoral approach (Femoral/Superior group; n = 22) and superior approach alone (Superior group; n = 53).

Results: No significant between-group differences were observed regarding patients' baseline characteristics except for a higher incidence of access vein occlusion in the Femoral/Superior group (59.1% vs. 31.4%;  = .037). The Femoral/Superior group exhibited significantly longer dwell times of the oldest extracted lead (median: 13.4 years; interquartile range [IQR]: 8.8-21.2 years vs. median, 7.2 years; IQR: 3.7-10.8 years;  < .001) and a higher incidence of passive fixation ventricular pacemaker lead (81.8% vs. 39.6%;  = .001). Multivariate logistic analysis showed that access vein occlusion (odds ratio [OR]: 4.07, 95% confidence interval [CI]: 1.08-15.3;  < .001) and dwell time of the oldest extracted lead (per year) (OR: 1.22, 95% CI: 1.09-1.37;  = .038) were predictors of the need for supportive femoral approach. Receiver operating characteristic curve analysis revealed that 11.8 years from implant was the cutoff for the need for supportive femoral approach (sensitivity 68.2%, specificity of 81.1%, area under the curve 0.81).

Conclusions: Access vein occlusion and long dwell time of the oldest extracted lead predict a high probability of the need for supportive femoral approach. Supportive femoral approach may be necessary in patients with leads that are implanted for >11.8 years and whose access veins are occluded.
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http://dx.doi.org/10.1002/joa3.12395DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7411205PMC
August 2020

Prenatal clinical manifestations in individuals with variants.

J Med Genet 2020 Jul 30. Epub 2020 Jul 30.

Department of Pediatric Neurology, Bobath Memorial Hospital, Osaka, Osaka, Japan.

Background: Variants in the type IV collagen gene () cause early-onset cerebrovascular diseases. Most individuals are diagnosed postnatally, and the prenatal features of individuals with variants remain unclear.

Methods: We examined in 218 individuals with suspected /2-related brain defects. Among those arising from variants, we focused on individuals showing prenatal abnormal ultrasound findings and validated their prenatal and postnatal clinical features in detail.

Results: Pathogenic variants were detected in 56 individuals (n=56/218, 25.7%) showing porencephaly (n=29), schizencephaly (n=12) and others (n=15). Thirty-four variants occurred de novo (n=34/56, 60.7%). Foetal information was available in 47 of 56 individuals, 32 of whom (n=32/47, 68.1%) had one or more foetal abnormalities. The median gestational age at the detection of initial prenatal abnormal features was 31 weeks of gestation. Only 14 individuals had specific prenatal findings that were strongly suggestive of features associated with variants. Foetal ventriculomegaly was the most common initial feature (n=20/32, 62.5%). Posterior fossa abnormalities, including Dandy-Walker malformation, were observed prenatally in four individuals. Regarding extrabrain features, foetal growth restriction was present in 16 individuals, including eight individuals with comorbid ventriculomegaly.

Conclusions: Prenatal observation of ventriculomegaly with comorbid foetal growth restriction should prompt a thorough ultrasound examination and gene testing should be considered when pathogenic variants are strongly suspected.
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http://dx.doi.org/10.1136/jmedgenet-2020-106896DOI Listing
July 2020

Preoperative predictors of lymph node metastasis in clinical T1 adenocarcinoma.

J Thorac Dis 2020 May;12(5):2352-2360

Department of Data Science, Yokohama City University, School of Data Science, Yokohama, Japan.

Background: The subcategory "solid component of tumor" is a new criterion of tumor categories in the updated eighth edition of the TNM classification. Nevertheless, the predictors of lymph node metastasis among patients with clinical T1 adenocarcinoma, based on the TNM classification 8 edition, remain unclear. This study aimed to identify the preoperative predictors of lymph node metastasis in clinical T1 adenocarcinoma by comparing clinicopathological characteristics between the groups with and without lymph node metastasis.

Methods: We performed a retrospective observational single-center study at the Sendai Kousei Hospital. From January 2012 to September 2019, we included 515 patients who underwent curative lobectomy or segmentectomy and mediastinal lymph node dissection among those with clinical T1 adenocarcinoma according to the UICC-TNM staging 8 edition. They were divided into two groups: those with lymph node metastasis (positive group) and those without (negative group). The clinicopathological factors were retrospectively analyzed and compared between the groups.

Results: In univariate analysis, carcinoembryonic antigen (>5.0 ng/mL) (P=0.0007), maximum standardized uptake (>3.5) (P<0.0001), clinical T factor (T1c) (P<0.0001), and consolidation tumor ratio (>0.85) (P<0.0001) were significant predictors of lymph node metastasis. Multivariate analysis revealed that maximum standardized uptake SUVmax (>3.5) (odds ratio =10.4, P<0.0001) was independently associated with lymph node metastasis. In univariate analysis, carcinoembryonic antigen (>5.0) (P=0.048) was the only predictor of lymph node metastasis among patients of cT1b, while no parameters were identified as significant predictors among patients of cT1c.

Conclusions: SUVmax and CEA are useful preoperative predictors of lymph node metastases in patients with clinical T1 adenocarcinoma, stratified to T1b and T1c, based on the 8 TNM classification.
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http://dx.doi.org/10.21037/jtd.2020.03.74DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7330315PMC
May 2020

Effect of liraglutide on lipids in patients with type 2 diabetes: a pilot study.

Endocr J 2020 Sep 16;67(9):957-962. Epub 2020 Jun 16.

Department of Endocrinology and Metabolism, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

The mechanism for the cholesterol-lowering effect of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) remains unknown in patients with type 2 diabetes. We evaluated the effect of liraglutide on serum lipid profiles, including cholesterol synthesis and absorption markers, during daily clinical practice in Japanese patients with type 2 diabetes. We enrolled 38 patients with type 2 diabetes mellitus who were not treated with a GLP-1 RA (≥20 years of age, HbA1c ≥6.5%). Liraglutide, a GLP-1 RA, was administered subcutaneously once a day for three months to these patients. Blood samples and body weights were collected at 0, 1, and 3 months. Total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) at 1 month, and non-high-density lipoprotein cholesterol (non-HDL-C) and calculated TC at 1 and 3 months, were decreased, while the cholesterol synthesis and cholesterol absorption markers were unchanged by this treatment. In patients with LDL-C levels over 100 mg/dL, LDL-C, non-HDL-C, TC, and calculated TC levels were decreased significantly by the treatment at 1 and 3 months, and the cholesterol absorption marker, campesterol, was decreased at 3 months. The administration of liraglutide for 3 months decreased non-HDL-C and calculated TC significantly, while the cholesterol synthesis and absorption markers were not changed by this treatment.
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http://dx.doi.org/10.1507/endocrj.EJ19-0464DOI Listing
September 2020

Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study.

Trials 2020 Jun 1;21(1):453. Epub 2020 Jun 1.

Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.

Background: Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC.

Methods: This proof-of-concept, prospective, randomized controlled trial commenced in Japan in March 2018. Initially, a questionnaire-based survey will be conducted targeting adult patients with cancer who concomitantly commenced opioid treatment and OIC prevention treatment. Patients will then be randomly allocated to a magnesium oxide group (500 mg thrice daily) or a naldemedine group (0.2 mg once daily). Each drug will be orally administered for 12 weeks. The primary endpoint is defined as any improvement in scores on the Japanese version of Patient Assessment of Constipation Quality of Life questionnaire (JPAC-QOL) from baseline to 2 weeks of treatment.

Discussion: The primary endpoint is change in JPAC-QOL score from baseline to 2 weeks of intervention. The key secondary endpoint will be change in spontaneous bowel movements at 2 and 12 weeks of intervention. This study will determine whether magnesium oxide or naldemedine is more effective for the prevention of OIC.

Trial Registration: University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000031891. Registered March 25, 2018.
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http://dx.doi.org/10.1186/s13063-020-04385-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7268242PMC
June 2020

In-Hospital Mortality in Acute Myocardial Infarction According to Population Density and Primary Angioplasty Procedures Volume.

Circ J 2020 06 27;84(7):1140-1146. Epub 2020 May 27.

Division of Cardiology, Yokohama City University Medical Center.

Background: Low population density may be associated with high mortality in acute myocardial infarction (AMI) patients. The purpose of this study was to investigate the effect of population density and hospital primary percutaneous coronary intervention (PCI) volume on AMI in-hospital mortality in Japan.Methods and Results:This is a retrospective study of 64,414 AMI patients transported to hospital by ambulances. The main outcome measure was in-hospital mortality. The median population density was 1,147 (interquartile range, 342-5,210) persons/km. There was a significant negative relationship between population density and in-hospital mortality (OR for a quartile down in population density 1.086, 95% CI 1.042-1.132, P<0.001). Patients in less densely populated areas were more often transported to hospitals with a lower primary PCI volume, and they had a longer distance to travel. By using multivariable analysis, primary PCI volume was found to be significantly associated with in-hospital mortality, but distance to hospital was not. When divided into the low- and high-volume hospitals, using the cut-off value of 115 annual primary PCI procedures, the increase in in-hospital mortality associated with low population density was observed only in patients hospitalized in the low-volume hospitals.

Conclusions: Increased in-hospital mortality related to low population density was observed only in AMI patients who were transported to the low primary PCI volume hospitals, but not in those who were transported to high-volume hospitals.
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http://dx.doi.org/10.1253/circj.CJ-19-0869DOI Listing
June 2020

Does screening for prostate cancer improve cancer-specific mortality in Asian men? Real-world data in Yokosuka City 15 years after introducing PSA-based population screening.

Prostate 2020 08 20;80(11):824-830. Epub 2020 May 20.

Department of Urology, Yokosuka Kyosai Hospital, Yokosuka, Japan.

Background: Studies of prostate-specific antigen (PSA)-based population screening have been conducted in western countries, but there is little data in Asian populations. The objective of this study was to determine the efficacy of PSA screening in Asian men using real-world data over a period of 15 years after introducing population screening in Yokosuka City, Japan.

Methods: We investigated patients with pathologically diagnosed prostate cancer at four hospitals and two clinics across the Yokosuka area (Miura peninsula) between April 2001 and March 2015. Patients were divided into two groups; the S group consisted of those diagnosed by PSA-based population screening in Yokosuka City and the NS group consisted of those diagnosed by methods other than screening. Cancer-specific survival (CSS) and overall survival (OS) rates were calculated using the Kaplan-Meier method with the log-rank test to compare survival between the two groups. Clinical and pathological factors for cancer-specific mortality were assessed with Cox regression analyses to calculate the hazard ratio (HR) and 95% confidence interval (CI).

Results: A total of 3094 patients had been diagnosed with prostate cancer over the 15-year period. The median follow-up period was 77 months. The S group and the NS group consisted of 977 and 2117 patients, respectively. Patients in the S group were younger (age: 71 years vs 73 years, P < .001) and had a lower Charlson comorbidity index (CCI) with favorable oncological factors, such as lower initial PSA, Gleason score (GS), and risk category. Kaplan-Meier curves for OS and CSS revealed significant differences between the two groups (OS: P < .001, CSS: P < .001). Analysis with Cox proportional hazards model indicated the NS group (HR: 1.584, 95% CI, 1.065-2.356, P = .023), a CCI > 4 (HR: 1.552, 95% CI, 1.136-2.120, P = .006), a GS ≥ 8 (HR: 4.869, 95% CI, 2.631-9.001, P < .001), and nonlocalized cancer (locally advanced; HR: 2.632, 95% CI, 1.676-4.133, P < .001, advanced; HR: 9.468, 95% CI, 6.279-14.278, P < .001) as independent risk factors for cancer-specific mortality.

Conclusions: PSA-based population screening of prostate cancer might be useful in the Japanese population.
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http://dx.doi.org/10.1002/pros.23997DOI Listing
August 2020