1.A multicenter comparative study of endoscopic ultrasound-guided fine-needle biopsy using a Franseen needle versus conventional endoscopic ultrasound-guided fine-needle aspiration to evaluate microsatellite instability in patients with unresectable pancreatic cancer
Tadayuki TAKAGI ; Mitsuru SUGIMOTO ; Hidemichi IMAMURA ; Yosuke TAKAHATA ; Yuki NAKAJIMA ; Rei SUZUKI ; Naoki KONNO ; Hiroyuki ASAMA ; Yuki SATO ; Hiroki IRIE ; Jun NAKAMURA ; Mika TAKASUMI ; Minami HASHIMOTO ; Tsunetaka KATO ; Ryoichiro KOBASHI ; Yuko HASHIMOTO ; Goro SHIBUKAWA ; Shigeru MARUBASHI ; Takuto HIKICHI ; Hiromasa OHIRA
Clinical Endoscopy 2023;56(1):107-113
Background/Aims:
Immune checkpoint blockade has recently been reported to be effective in treating microsatellite instability (MSI)-high tumors. Therefore, sufficient sampling of histological specimens is necessary in cases of unresectable pancreatic cancer (UR-PC). This multicenter study investigated the efficacy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) using a Franseen needle for MSI evaluation in patients with UR-PC.
Methods:
A total of 89 patients with UR-PC who underwent endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or EUS-FNB using 22-G needles at three hospitals in Japan (2018–2021) were enrolled. Fifty-six of these patients (FNB 23 and FNA 33) were followed up or evaluated for MSI. Patient characteristics, UR-PC data, and procedural outcomes were compared between patients who underwent EUS-FNB and those who underwent EUS-FNA.
Results:
No significant difference in terms of sufficient tissue acquisition for histology was observed between patients who underwent EUS-FNB and those who underwent EUS-FNA. MSI evaluation was possible significantly more with tissue samples obtained using EUS-FNB than with tissue samples obtained using EUS-FNA (82.6% [19/23] vs. 45.5% [15/33], respectively; p<0.01). In the multivariate analysis, EUS-FNB was the only significant factor influencing the possibility of MSI evaluation.
Conclusions
EUS-FNB using a Franseen needle is desirable for ensuring sufficient tissue acquisition for MSI evaluation.
2.Autologous Blood Donation for Patients With Low-Lying Placenta
Heisuke HIROWATARI ; Shigeru TODA ; Mai FUJIKURA ; Keita KURODA ; Mayuko BANDO ; Komei KATAYAMA ; Maya HANATANI ; Takuto NAKAMURA ; Aya SOBAJIMA ; Hiromi FUJIKI ; Akiko FUKATSU ; Takayasu SUGANUMA ; Takahiro SUZUKI
Journal of the Japanese Association of Rural Medicine 2021;70(4):354-359
This study was undertaken to elucidate the usefulness and problems of autologous blooddonation for the patients with low-lying placenta. Seventy-eight women with low-lying placentawho gave birth in our institution were retrospectively analyzed. Autologous blood donation wasperformed in 58 patients (74%). The median volume of donated blood was 300 mL. Patients withor without autologous blood donation showed no significant difference in the distance betweenthe edge of the placenta and the internal os of the uterus. Median blood loss due to intrapartumhemorrhage was 1183 mL. All 7 patients with blood loss of more than 2000 mL had donatedautologous blood. The donated blood was transfused in 9 of the 58 patients (16%) who underwentautologous blood donation. No patients underwent allogenic blood transfusion. Althoughautologous blood donation was expected to be useful for avoiding allogenic blood transfusion inthese patients with low-lying placenta, the high discard rate suggests the need for a strategy toselect those patients at high risk for blood loss requiring transfusion.
3.The acute effect of stretching on eccentrically-damaged muscle: analysis of differences between Hold relax stretching and modified PNF stretching
Kaoru YAHATA ; Shigeru SATO ; Ryosuke KIYONO ; Kazuki INABA ; Shigeki SUTOH ; Kakeru HIRAIZUMI ; Masatoshi NAKAMURA
Japanese Journal of Physical Fitness and Sports Medicine 2020;69(1):157-164
It is well known that eccentric exercise induces muscle damage that is characterized by a prolonged decrease in muscle strength and range of motion, development of delayed onset muscle soreness. The previous studies showed that hold-relax stretching (HRS) was effective for improving the decreases in range of motion and muscle soreness. In addition, modified proprioceptive neuromuscular facilitation stretching (mPNF) was an equally effective for HRS. However, it was unclear whether there are differences between acute effects of HRS and mPNF on muscle strength and muscle soreness in eccentrically damaged muscle. Therefore, the present study aimed to compare the acute effects of HRS with those of mPNF on muscle strength and soreness in eccentrically damaged muscle. The participants comprised 40 volunteers randomly assigned to either the HRS group (N = 20) or the mPNF group (N = 20). Initially, the participants of both groups performed 60 maximal eccentric contractions of the knee extensors. Two days after this exercise, each group performed either HRS or mPNF for 60 s at a time and repeated them six times for a total of 360 s. Muscle strength and soreness during stretching and contraction were measured before and immediately after HRS and mPNF. The results showed that the muscle soreness observed after eccentric contraction significantly decreased immediately after both HRS and mPNF. In addition, there were no significant changes in muscle strength immediately after both HRS and mPNF. These results suggest that while both HRS and mPNF can effectively decrease muscle soreness without reducing performance.
4.Checklist and Guidance of Scientific Approach to Developing Pharmacovigilance Plan (PVP) in Japan: A Report from a Task Force of JSPE
Kiyoshi KUBOTA ; Kotonari AOKI ; Hisashi URUSHIHARA ; Tatsuo KAGIMURA ; Shigeru KAGEYAMA ; Daisuke KOIDE ; Akira KOKAN ; Tsugumichi SATO ; Toshiaki NAKAMURA ; Ken NAKAJIMA ; Naoya HATANAKA ; Takeshi HIRAKAWA ; Kou MIYAKAWA ; Mayumi MOCHIZUKI
Japanese Journal of Pharmacoepidemiology 2014;19(1):57-74
A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.
1.Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities
2.How to select Safety Specification (SS) and describe its characteristics
・Selection of SS
・Characterization of SS
・Association with Research Questions (RQ)
3.How to define and describe RQ
・What is RQ ?
・RQ interpretation in other relevant guidelines
・Methodology to develop RQ for PVP with examples
・Best approach to integrating PVP for whole aspects of safety concern
4.How to optimize PVP for specific RQ
・Routine PVP or additional PVP ?
・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)
・Checklist to help develop PVP
5.Epilogue:
・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.
・Significance of background incidence rate and needs for comparator group
・Infrastructure for the future PVP activities
6.Appendix: Checklist to help develop PVP activities in RMP
The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.
5.Near-infrared spectroscopic assessment of human hemoglobin dynamics associated with pressure stimulation applied by protrusion-lined innerware
Tatsuzo NAKAMURA ; Shigeru KAWAMURA ; Hirosi KITAKOJI ; Atsuko KAWAMURA ; Kenji IMAI ; Hideaki MATSUKUMA
Journal of the Japan Society of Acupuncture and Moxibustion 2010;60(2):234-243
(Object) We, in collaboration with Wacoal Corp., assessed the effects of human hemoglobin dynamics associated with pressure stimulus applied by half-ovoid protrusions lined on brassiere straps, which were developed with an intended use by females to safely alleviate shoulder stiffness and associated pain in a convenient manner, and compared them to those of conventional flat and round magnets (5 mm in diameter, 800 Gauss).
(Method) Six healthy females volunteered for each of the four experiments. The participants'thoracic circumference or band size was 70 cm (B70) for experiments one and two, and 80 cm (B80) for three and four. For experiments one and three, we obtained the control hemoglobin (Hb) values, by near-infrared spectroscopy, 20 minutes after participants had worn brassieres with the newly developed straps turned inside out;and were compared to the values obtained after the straps were worn with protrusions pressing down on the skin (Protrusion-lined Strap Group, PST). For experiments two and four, the control Hb values were obtained after the participants had worn generic brassiere straps, and were compared to Hb values obtained after the magnet-lined straps were worn (Magnet-lined Strap Group, MSG).
(Result) In the PSG (B70 &B80), both Oxy-Hb and Total-Hb values increased by stimulation with a 5%significant difference;however, no significant increase was observed in the MSG (B70 &B80). There was no significant difference depending on the band size.
(Discussion) In the present study, the post-stimulation increase of Hb values showed significant differences in PSG as a result of stimulation by protrusions. Stimulation by flat magnets demonstrated no such significance on Hb values, presumably due to the lower pressure to the skin. Stimulation by magnets showed no significant changes in total Hb values despite prior reports of it accelerating the blood flow. The shape with which pressure is applied against the skin may have relevance to the effect of stimulation.
Protrusions left post-stimulation depression marks and flare on the skin surface, suggesting the possible involvement of mechanothermal polymodal receptors.
(Conclusion) Stimulation with the protrusions we developed increased Hb values, showing a regional concentration of hemoglobin. This suggests that it is effective in alleviating shoulder stiffness and associated pain, and lining brassiere straps with the protrusions provides a means for females to self-apply such stimulation safely and conveniently.
6.Angiographic follow-up of 293 patients receiving placement of long coronary stents with different diameters.
Zheng HUANG ; Nakamura SHIGERU ; Katoh OSAMU
Journal of Southern Medical University 2008;28(8):1419-1421
OBJECTIVETo assess the acute and long-term angiographic outcome of placement of long stents with different diameters for treatment of long diffuse coronary lesions.
METHODSAcute and long-term (3-and 6-month follow-up) quantitative coronary angiographic (QCA) data were obtained from 293 consecutive patients (65.9-/+8.2 years old, including 232 male patients) with long stent placement. The patients were divided into 4 groups according to the diameter of the stent implanted: group A (diameter> or =4.0 mm, n=68), Group B (3.5 mm< or =diameter < 4.0 mm, n=113), Group C (3.0 mm < or = diameter <3.5 mm, n=90) and Group D (2.5 mm< or =diameter<3.0 mm, n=22). The baseline demographic, angiographic and procedural details were similar in these 4 groups.
RESULTSThe procedural success rate was 100%. In groups A, B, C and D, the mean lesion length (LL) before the procedure was 20.92-/+10.96 mm, 20.01-/+10.07 mm, 20.13-/+11.08 mm and 23.08-/+6.51 mm (P=NS), with average total stent length for each lesion of 28.40-/+5.10 mm, 29.85-/+8.47 mm, 30.20-/+7.13 mm and 26.42-/+4.85 mm, respectively (P=NS). At 3- and 6-month angiographic follow-up, the angiographic binary lesion restenosis rate was significantly higher in the smaller-stent group (8.8%, 15.0%, 33.3% and 72.7% at 3-month, and 17.6%, 25.7%, 41.1% and 72.7% at 6-month follow-up, respectively, P<0.001 between each 2 groups). Group A had reduced target vessel revascularization rate compared with groups B, C and D (19.1% vs 30.1%, 54.4% and 72.7% at 3-month; 30.9% vs 44.2%, 66.7% and 81.8% at 6-month follow-up, P<0.001) at follow-up. These differences appeared to result from a lesser acute gain and a lesser net gain in smaller-stent group.
CONCLUSIONLong stents of larger diameters result in a significant reduction of angiographic restenosis rate and target vessel revascularization rate for the management of long diffuse lesion.
Aged ; Angioplasty, Balloon, Coronary ; methods ; Coronary Angiography ; Coronary Artery Disease ; diagnostic imaging ; therapy ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Stents
7.Evaluation of long stent implantation in diffuse coronary lesions for octogenarians
Zheng HUANG ; Hongwu CHEN ; Osamu KATOH ; Shigeru NAKAMURA
Journal of Geriatric Cardiology 2005;2(1):29-35
Objective To evaluate angiographic and clinical outcomes of ≥ 20mm long stents or overlapped stent implantation in diffuse coronary lesions for octogenarians, in comparison with patients under sixty. Methods Two groups (Group O: 47 lesions in 44 octogenarians, aged 81± 3 years; Group Y: 64 lesions in 58 patients under sixty, aged 54 ± 4 years) were compared with a 6-month follow-up. Results Success rate of the procedures was 100%. None had in-hospital major adverse cardiac events (MACE). There was no significant difference in angiographic restenosis between the groups at follow-up (Group O vs Group Y, 29.8 % vs 26.6 %, P = NS). The revascularization of target vessel and MACE was less in Group Y, but these showed no statistical significance (15.6% vs 23.4% and 20.7% vs 25.0%, respectively). Conclusions Long stent implantation for diffuse coronary lesions in octogenarians appears safe and feasible, with high procedural success and favorable long-term outcomes.
8.Angiographic and clinical follow-up of long stent implantation for diffuse coronary lesions in octogenarians
Zheng HUANG ; Hongwu CHEN ; Osamu KATOH ; Shigeru NAKAMURA
Chinese Journal of Geriatrics 2003;0(10):-
0.05). Conclusions Long stent implantation for diffuse lesions in octogenarians appears safe and feasible, with high procedural success and favorable long-term outcomes.
9.Objectification of Diagnosis in Acupuncture and Moxibustion; Increased Fluctuation of Meridian Functions Measured by AMI after Acupuncture Treatment According to the Low of the Five Elements.
Munenori MINAGAWA ; Tatsuyo ISHIGAMI ; Shigeru HORI ; Hironori NAKAMURA ; Ko YAMADA ; Yoshiyuki KAWASE ; Teruo HATTORI ; Akira KINUTA ; Yoshihiro KARINO ; Yoshimi MARUYAMA ; Yasuzo KURONO
Journal of the Japan Society of Acupuncture and Moxibustion 2001;51(2):165-169
Research on pulse diagnosis conducted so far by Kurono et al. includes a study on pulse diagnosis and six basic pulses and a study on the application of AMI (an apparatus for measuring the function of the meridian and corresponding internal organs) to pulse diagnosis.
In this study, fluctuation of the meridian functions with or without acupuncture treatment according to the law of the five elements were examined objectively using BP values measured by AMI. When BP values were measured for 10 times without acupuncture treatment, the values for the respective meridiansfluctuated in a stable manner, averaging 4% or less. As a result of testing 6 subjects using this meridian treatment according to the law of the five elements, fluctuation of the meridian functions increased in the oriental medical diagnosis of all the subjects.
Thus, the results of this study showed the feasibility of using AMI for objectively evaluating the fluctuation of meridian functions. The authors intend to continue to examine the relationship between diagnosis and acupuncture using AMI.
10.Effectiveness of the Zusanli (ST36) Point for Hypertension in acupuncture. Controlled clinical trials using the Envelope Method.
Yoshiyuki KAWASE ; Tatsuyo ISHIGAMI ; Shigeru HORI ; Hironori NAKAMURA ; Teruo HATTORI ; Norikazu TANAKA ; Akira KINUTA ; Hideyuki HIRAMATSU ; Munenori MINAGAWA ; Yasuzo KURONO
Journal of the Japan Society of Acupuncture and Moxibustion 2000;50(2):185-189
With the aim of investigating the effect of drop in blood pressure of the Zusanli (ST36), a multi-center randomized controlled trial was conducted with the envelope method. Patients showing the high blood pressure condition were divided into 2 of the group treated with use of the Zusanli point and the group with non-use of Zusanli point.Changes in blood pressure were then measured.The present results show no significant difference was seen between the 2 groups, thus did not find the Zusanli point to be effective.


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