1.Evaluation of the mechanical properties of current biliary self-expandable metallic stents: axial and radial force, and axial force zero border
Wataru YAMAGATA ; Toshio FUJISAWA ; Takashi SASAKI ; Rei ISHIBASHI ; Tomotaka SAITO ; Shuntaro YOSHIDA ; Shizuka NO ; Kouta INOUE ; Yousuke NAKAI ; Naoki SASAHIRA ; Hiroyuki ISAYAMA
Clinical Endoscopy 2023;56(5):633-649
Background/Aims:
Mechanical properties (MPs) and axial and radial force (AF and RF) may influence the efficacy and complications of self-expandable metallic stent (SEMS) placement. We measured the MPs of various SEMSs and examined their influence on the SEMS clinical ability.
Methods:
We evaluated the MPs of 29 types of 10-mm SEMSs. RF was measured using a conventional measurement device. AF was measured using the conventional and new methods, and the correlation between the methods was evaluated.
Results:
A high correlation in AFs was observed, as measured by the new and conventional manual methods. AF and RF scatterplots divided the SEMSs into three subgroups according to structure: hook-and-cross-type (low AF and RF), cross-type (high AF and low RF), and laser-cut-type (intermediate AF and high RF). The hook-and-cross-type had the largest axial force zero border (>20°), followed by the laser-cut and cross types.
Conclusions
MPs were related to stent structure. Hook-and-cross-type SEMSs had a low AF and high axial force zero border and were considered safest because they caused minimal stress on the biliary wall. However, the increase in RF must be overcome.
2.Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer
Naoya MURAKAMI ; Miho WATANABE ; Takashi UNO ; Shuhei SEKII ; Kayoko TSUJINO ; Takahiro KASAMATSU ; Yumiko MACHITORI ; Tomomi AOSHIKA ; Shingo KATO ; Hisako HIROWATARI ; Yuko KANEYASU ; Tomio NAKAGAWA ; Hitoshi IKUSHIMA ; Ken ANDO ; Masumi MURATA ; Ken YOSHIDA ; Hiroto YOSHIOKA ; Kazutoshi MURATA ; Tatsuya OHNO ; Noriyuki OKONOGI ; Anneyuko I. SAITO ; Mayumi ICHIKAWA ; Takahito OKUDA ; Keisuke TSUCHIDA ; Hideyuki SAKURAI ; Ryoichi YOSHIMURA ; Yasuo YOSHIOKA ; Atsunori YOROZU ; Naonobu KUNITAKE ; Hiroyuki OKAMOTO ; Koji INABA ; Tomoyasu KATO ; Hiroshi IGAKI ; Jun ITAMI
Journal of Gynecologic Oncology 2023;34(3):e24-
Objective:
The purposes of this trial were to demonstrate the feasibility and effectiveness of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced cervical cancer patients in the phase I/II prospective clinical trial.
Methods:
Patients with FIGO stage IB2-IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by magnetic resonance imaging were eligible for this clinical trial. The protocol therapy included 30–30.6 Gy in 15–17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of HBT and pelvic radiotherapy with a central shield up to 50–50.4 Gy in 25–28 fractions. The primary endpoint of phase II part was 2-year pelvic progression-free survival (PPFS) rate higher than historical control of 64%.
Results:
Between October 2015 and October 2019, 73 patients were enrolled in the initial registration and 52 patients proceeded to the secondary registration. With the median follow-up period of 37.3 months (range, 13.9–52.9 months), the 2- PPFS was 80.7% (90% confidence interval [CI]=69.7%–88%). Because the lower range of 90% CI of 2-year PPFS was 69.7%, which was higher than the historical control ICBT data of 64%, therefore, the primary endpoint of this study was met.
Conclusion
The effectiveness of HBT were demonstrated by a prospective clinical study. Because the dose goal determined in the protocol was lower than 85 Gy, there is room in improvement for local control. A higher dose might have been needed for tumors with poor responses.
3.Current Treatment Strategy for Superficial Nonampullary Duodenal Epithelial Tumors
Tetsuya SUWA ; Kohei TAKIZAWA ; Noboru KAWATA ; Masao YOSHIDA ; Yohei YABUUCHI ; Yoichi YAMAMOTO ; Hiroyuki ONO
Clinical Endoscopy 2022;55(1):15-21
Endoscopic submucosal dissection (ESD) is the standard treatment method for esophageal, gastric, and colorectal cancers. However, it has not been standardized for duodenal lesions because of its high complication rates. Recently, minimally invasive and simple methods such as cold snare polypectomy and underwater endoscopic mucosal resection have been utilized more for superficial nonampullary duodenal epithelial tumors (SNADETs). Although the rate of complications associated with duodenal ESD has been gradually decreasing because of technical advancements, performing ESD for all SNADETs is unnecessary. As such, the appropriate treatment plan for SNADETs should be chosen according to the lesion type, patient condition, and endoscopist’s skill.
4.Urinary N-terminal pro-B-type natriuretic peptide as a biomarker for cardiovascular events in a general Japanese population: the Hisayama Study.
Keisuke YAMASAKI ; Jun HATA ; Tomomi IDE ; Takuya NAGATA ; Satoko SAKATA ; Daigo YOSHIDA ; Takanori HONDA ; Yoichiro HIRAKAWA ; Toshiaki NAKANO ; Takanari KITAZONO ; Hiroyuki TSUTSUI ; Toshiharu NINOMIYA
Environmental Health and Preventive Medicine 2021;26(1):47-47
BACKGROUND:
Epidemiological evidence has shown that serum N-terminal pro-brain natriuretic peptide (NT-proBNP) concentrations, a diagnostic biomarker for heart failure, are positively associated with cardiovascular risk. Since NT-proBNP in serum is excreted in urine, it is hypothesized that urinary NT-proBNP concentrations are correlated with serum concentrations and linked with cardiovascular risk in the general population.
METHODS:
A total of 3060 community-dwelling residents aged ≥ 40 years without history of cardiovascular disease (CVD) were followed up for a median of 8.3 years (2007-2015). Serum and urinary concentrations of NT-proBNP at baseline were compared. The hazard ratios (HRs) and their 95% confidence intervals (CIs) for the association between NT-proBNP concentrations and the risk of developing CVD were computed using the Cox proportional hazards model.
RESULTS:
The median values (interquartile ranges) of serum and urinary NT-proBNP concentrations at baseline were 56 (32-104) pg/mL and 20 (18-25) pg/mL, respectively. There was a strong quadratic correlation between the serum and urinary concentrations of NT-proBNP (coefficient of determination [R
CONCLUSIONS
The present study demonstrated that urinary NT-proBNP concentrations were well-correlated with serum concentrations and were positively associated with cardiovascular risk. Given that urine sampling is noninvasive and does not require specially trained personnel, urinary NT-proBNP concentrations have the potential to be an easy and useful biomarker for detecting people at higher cardiovascular risk.
Adult
;
Aged
;
Aged, 80 and over
;
Biomarkers/urine*
;
Cardiovascular Diseases/urine*
;
Female
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Heart Failure/diagnosis*
;
Humans
;
Incidence
;
Japan/epidemiology*
;
Male
;
Middle Aged
;
Natriuretic Peptide, Brain/urine*
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Peptide Fragments/urine*
;
Prospective Studies
;
Risk Assessment
5.Clinical practice guidelines for the management of biliary tract cancers 2019: the 3rd English edition
Masato NAGINO ; Satoshi HIRANO ; Hideyuki YOSHITOMI ; Taku AOKI ; Katsuhiko UESAKA ; Michiaki UNNO ; Tomoki EBATA ; Masaru KONISHI ; Keiji SANO ; Kazuaki SHIMADA ; Hiroaki SHIMIZU ; Ryota HIGUCHI ; Toshifumi WAKAI ; Hiroyuki ISAYAMA ; Takuji OKUSAKA ; Toshio TSUYUGUCHI ; Yoshiki HIROOKA ; Junji FURUSE ; Hiroyuki MAGUCHI ; Kojiro SUZUKI ; Hideya YAMAZAKI ; Hiroshi KIJIMA ; Akio YANAGISAWA ; Masahiro YOSHIDA ; Yukihiro YOKOYAMA ; Takashi MIZUNO ; Itaru ENDO
Chinese Journal of Digestive Surgery 2021;20(4):359-375
The Japanese Society of Hepato-Biliary-Pancreatic Surgery launched the clinical practice guidelines for the management of biliary tract cancers (cholangiocarcinoma, gallbladder cancer, and ampullary cancer) in 2007, then published the 2nd version in 2014. In this 3rd version, clinical questions (CQs) were proposed on six topics. The recommendation, grade for recommendation, and statement for each CQ were discussed and finalized by an evidence-based approach. Recommendations were graded as grade 1 (strong) or grade 2 (weak) according to the concepts of the grading of recommendations assessment, development, and evaluation system. The 31 CQs covered the six topics: (1) prophylactic treatment, (2) diagnosis, (3) biliary drainage, (4) surgical treatment, (5) chemotherapy, and (6) radiation therapy. In the 31 CQs, 14 recommendations were rated strong and 14 recommendations weak. The remaining three CQs had no recommendation. Each CQ includes a statement of how the recommendations were graded. This latest guideline provides recommendations for important clinical aspects based on evidence. Future collaboration with the cancer registry will be key for assessing the guidelines and establishing new evidence.
6.Saikokaryukotsuboreito Could be Effective Even if Shakanzoto is Ineffective for Paroxysmal Atrial Fibrillation with Strong Palpitation after Cardiac Surgery
Koji KAWAGO ; Yukiyo YOSHIDA ; Satoru SHIRAIWA ; Yoshihiro HONDA ; Kenji SAKAKIBARA ; Shigeaki KAGA ; Hiroyuki NAKAJIMA
Kampo Medicine 2021;72(1):27-33
Paroxysmal atrial fibrillation (pAf) is an arrhythmia that often occurs in the elderly. The quality of life often declines due to severe palpitations caused by pAf. We present a case of recurrent pAf that occurred on postoperative day 2 of coronary artery bypass grafting and pulmonary vein isolation for unstable angina pectoris and pAf. The patient was a 62-year-old man who complained of palpitations, which was consistent with pAf on the monitor ECG. During hospitalization, the patient was constantly wearing an ECG monitor. During pAf, the heart rate was around 120 bpm, and pAf could continue for up to and beyond 24 hours. Paroxysmal atrial fibrillation with strong palpitations was observed every day, even after starting beta-blockers and anticoagulants. After discharge, a Japanese Kampo medicine called shakanzoto was taken for a month, but there was no improvement. After that, it was changed to another Japanese Kampo medicine called saikokaryukotsuboreito, because abdominal examination revealed kyokyokuman (hypochondriac discomfort and distension (resistance)) and saiboki (brisk pulsation in the para-umbilical region). Palpitations quickly improved dramatically. It was speculated that not only palpitations but also pAf had been improved.
7.Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial
Keiichi FUJIWARA ; Hiroyuki FUJIWARA ; Hiroyuki YOSHIDA ; Toyomi SATOH ; Kan YONEMORI ; Shoji NAGAO ; Takashi MATSUMOTO ; Hiroaki KOBAYASHI ; Hughes BOURGEOIS ; Philipp HARTER ; Anna Maria MOSCONI ; Isabel Palacio VAZQUEZ ; Alexander REINTHALLER ; Tomoko FUJITA ; Philip ROWE ; Eric PUJADE-LAURAINE ; Isabelle RAY-COQUARD
Journal of Gynecologic Oncology 2021;32(5):e82-
Objective:
The addition of maintenance olaparib to bevacizumab demonstrated a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1/ENGOT-ov25 trial (NCT02477644). We evaluated maintenance olaparib plus bevacizumab in the Japan subset of PAOLA-1.
Methods:
PAOLA-1 was a randomized, double-blind, phase III trial. Patients received maintenance olaparib tablets 300 mg twice daily or placebo twice daily for up to 24 months, plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total. This prespecified subgroup analysis evaluated investigator-assessed PFS (primary endpoint).
Results:
Of 24 randomized Japanese patients, 15 were assigned to olaparib and 9 to placebo. After a median follow-up for PFS of 27.7 months for olaparib plus bevacizumab and 24.0 months for placebo plus bevacizumab, median PFS was 27.4 versus 19.4 months, respectively (hazard ratio [HR]=0.34; 95% confidence interval [CI]=0.11–1.00). In patients with tumors positive for homologous recombination deficiency, the HR for PFS was 0.57 (95% CI=0.16–2.09). Adverse events in the Japan subset were generally consistent with those of the PAOLA-1 overall population and with the established safety and tolerability profiles of olaparib and bevacizumab.
Conclusion:
Results
in the Japan subset of PAOLA-1 support the overall conclusion of the PAOLA-1 trial demonstrating that the addition of maintenance olaparib to bevacizumab provides a PFS benefit in patients with newly diagnosed, advanced ovarian cancer.
8.A Case of Fungal Mycotic Abdominal Aortic Aneurysm with Candida albicans Sepsis
Yoshihiro HONDA ; Yukiyo YOSHIDA ; Koji KAWAGO ; Satoru SHIRAIWA ; Kenji SAKAKIBARA ; Shigeaki KAGA ; Hiroyuki NAKAJIMA
Japanese Journal of Cardiovascular Surgery 2020;49(6):375-379
Background : Fungal mycotic aneurysm is rare ; however, special care and treatment are required for the deep fungal infection itself. Case : The patient was a 69-year-old man with a history of sepsis due to Candida albicans. He suffered from back pain and moderate fever. CT revealed saccular-form aneurysm at the infrarenal abdominal aorta. After emergent in situ bifurcated graft replacement of the infected aneurysm, antifungal treatment was attempted in reference to the antifungal drug sensitivity of C. albicans from intraoperative cultures and findings of fungal endophthalmitis in an ophthalmic examination. After an uneventful acute course, follow up CT images after 12 months postoperatively revealed pseudoaneurysm formation proximal to the site of graft anastomosis. Reoperation was planned with a trans-thoracic and transabdominal approach because of concerns about thoracoabdominal aortic infection. However, the reoperation displayed only inflammatory tissue around the graft and aortic tissue. Removal of the previous graft and reconstruction of the bilateral renal artery, and the pararenal abdominal aorta to the bilateral common iliac artery was performed. Intraoperative tissue cultures revealed no evidence of microorganisms. He returned home with oral antifungal treatment and is doing well at 8 months after the reoperation. Conclusions : Management of fungal mycotic aneurysms requires both surgical treatment and antifungal treatment. Antifungal agents should be selected based on the results of a susceptibility test and after examinations for metastatic comorbidities.
9.Present Status of Endoscopic Submucosal Dissection for Non-Ampullary Duodenal Epithelial Tumors
Naomi KAKUSHIMA ; Masao YOSHIDA ; Yohei YABUUCHI ; Noboru KAWATA ; Kohei TAKIZAWA ; Yoshihiro KISHIDA ; Sayo ITO ; Kenichiro IMAI ; Kinichi HOTTA ; Hirotoshi ISHIWATARI ; Hiroyuki MATSUBAYASHI ; Hiroyuki ONO
Clinical Endoscopy 2020;53(6):652-658
Prediction of histology by endoscopic examination is important in the clinical management of non-ampullary duodenal epithelial tumors (NADETs), including adenoma and adenocarcinoma. The use of a simple scoring system based on the findings of white-light endoscopy or magnified endoscopy with narrow-band imaging is useful to differentiate between Vienna category 3 (C3) and C4/5 lesions. Less invasive endoscopic resection procedures, such as cold snare polypectomy, are quick to perform and convenient for small (<10 mm) C3 lesions. Neoplasms with higher grade histology, such as C4/5 lesions, should be treated by endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), or surgery. Although EMR often requires piecemeal resection, the complication rate is acceptable. Excellent complete resection rates could be achieved by ESD; however, it remains a challenging method considering the high risk of complications. Shielding or closure of the ulcer after ESD is effective at decreasing the risk of delayed bleeding and perforation. Laparoscopic endoscopic cooperative surgery is an ideal treatment with a high rate of en bloc resection and a low rate of complications, although it is limited to high-volume centers. Patients with NADETs could benefit from a multidisciplinary approach to stratify the optimal treatment based on endoscopic diagnoses.
10.Comparison of the Diagnostic Yield of the Standard 22-Gauge Needle and the New 20-Gauge Forward-Bevel Core Biopsy Needle for Endoscopic Ultrasound-Guided Tissue Acquisition from Pancreatic Lesions
Shinya FUJIE ; Hirotoshi ISHIWATARI ; Keiko SASAKI ; Junya SATO ; Hiroyuki MATSUBAYASHI ; Masao YOSHIDA ; Sayo ITO ; Noboru KAWATA ; Kenichiro IMAI ; Naomi KAKUSHIMA ; Kohei TAKIZAWA ; Kinichi HOTTA ; Hiroyuki ONO
Gut and Liver 2019;13(3):349-355
BACKGROUND/AIMS: To compare the diagnostic yield of 20-gauge forward-bevel core biopsy needle (CBN) and 22-gauge needle for endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) of solid pancreatic masses. METHODS: The use of 20-gauge CBN was prospectively evaluated for 50 patients who underwent EUS-FNA from June 2016 to December 2016. Data were compared with those obtained by a retrospective study of 50 consecutive patients who underwent EUS-FNA using standard 22-gauge needles between December 2016 and April 2017. At least two punctures were performed for each patient; the sample from the first pass was used for cytology with or without histology and that from the second pass was used for histology. Sample quantity was evaluated using the sample obtained from the second pass. RESULTS: There was no significant difference in the diagnostic accuracy rate between the first and second passes (20-gauge CBN: 96% [48/50]; standard 22-gauge needle: 88% [44/50]). Samples >10× power fields in length were obtained from 90% (43/48) and 60% (30/50) of patients using the 20-gauge CBN and standard 22-gauge needle, respectively (p=0.01). Technical failure occurred for two patients with the 20-gauge CBN. CONCLUSIONS: Diagnostic accuracy of the 20-gauge CBN was comparable to that of the 22-gauge needle. However, two passes with the 20-gauge CBN yielded a correct diagnosis for 100% of patients when technically feasible. Moreover, the 20-gauge CBN yielded core tissue for 90% patients, which was a performance superior to that of the 22-gauge needle.
Biopsy
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Biopsy, Fine-Needle
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Diagnosis
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Endoscopic Ultrasound-Guided Fine Needle Aspiration
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Humans
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Needles
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Pancreas
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Prospective Studies
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Punctures
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Retrospective Studies
;
Ultrasonography


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