1.Effectiveness of a novel ex vivo training model for gastric endoscopic submucosal dissection training: a prospective observational study conducted at a single center in Japan
Takahito TOBA ; Tsuyoshi ISHII ; Nobuyuki SATO ; Akira NOGAMI ; Aya HOJO ; Ryo SHIMIZU ; Ai FUJIMOTO ; Takahisa MATSUDA
Clinical Endoscopy 2025;58(1):94-101
Background/Aims:
The efficacy of endoscopic submucosal dissection (ESD) for early-stage gastric cancer is well established. However, its acquisition is challenging owing to its complexity. In Japan, G-Master is a novel ex vivo gastric ESD training model. The effectiveness of training using G-Master is unknown. This study evaluated the efficacy of gastric ESD training using the G-Master to evaluate trainees’ learning curves and performance.
Methods:
Four trainees completed 30 ESD training sessions using the G-Master, and procedure time, resection area, resection completion, en-bloc resection requirement, and perforation occurrence were measured. Resection speed was the primary endpoint, and learning curves were evaluated using the Cumulative Sum (CUSUM) method.
Results:
All trainees completed the resection and en-bloc resection of the lesion without any intraoperative perforations. The learning curves covered three phases: initial growth, plateau, and late growth. The transition from phase 1 to phase 2 required a median of 10 sessions. Each trainee completed 30 training sessions in approximately 4 months.
Conclusions
Gastric ESD training using the G-Master is a simple, fast, and effective method for pre-ESD training in clinical practice. It is recommended that at least 10 training sessions be conducted.
2.Effectiveness of a novel ex vivo training model for gastric endoscopic submucosal dissection training: a prospective observational study conducted at a single center in Japan
Takahito TOBA ; Tsuyoshi ISHII ; Nobuyuki SATO ; Akira NOGAMI ; Aya HOJO ; Ryo SHIMIZU ; Ai FUJIMOTO ; Takahisa MATSUDA
Clinical Endoscopy 2025;58(1):94-101
Background/Aims:
The efficacy of endoscopic submucosal dissection (ESD) for early-stage gastric cancer is well established. However, its acquisition is challenging owing to its complexity. In Japan, G-Master is a novel ex vivo gastric ESD training model. The effectiveness of training using G-Master is unknown. This study evaluated the efficacy of gastric ESD training using the G-Master to evaluate trainees’ learning curves and performance.
Methods:
Four trainees completed 30 ESD training sessions using the G-Master, and procedure time, resection area, resection completion, en-bloc resection requirement, and perforation occurrence were measured. Resection speed was the primary endpoint, and learning curves were evaluated using the Cumulative Sum (CUSUM) method.
Results:
All trainees completed the resection and en-bloc resection of the lesion without any intraoperative perforations. The learning curves covered three phases: initial growth, plateau, and late growth. The transition from phase 1 to phase 2 required a median of 10 sessions. Each trainee completed 30 training sessions in approximately 4 months.
Conclusions
Gastric ESD training using the G-Master is a simple, fast, and effective method for pre-ESD training in clinical practice. It is recommended that at least 10 training sessions be conducted.
3.Effectiveness of a novel ex vivo training model for gastric endoscopic submucosal dissection training: a prospective observational study conducted at a single center in Japan
Takahito TOBA ; Tsuyoshi ISHII ; Nobuyuki SATO ; Akira NOGAMI ; Aya HOJO ; Ryo SHIMIZU ; Ai FUJIMOTO ; Takahisa MATSUDA
Clinical Endoscopy 2025;58(1):94-101
Background/Aims:
The efficacy of endoscopic submucosal dissection (ESD) for early-stage gastric cancer is well established. However, its acquisition is challenging owing to its complexity. In Japan, G-Master is a novel ex vivo gastric ESD training model. The effectiveness of training using G-Master is unknown. This study evaluated the efficacy of gastric ESD training using the G-Master to evaluate trainees’ learning curves and performance.
Methods:
Four trainees completed 30 ESD training sessions using the G-Master, and procedure time, resection area, resection completion, en-bloc resection requirement, and perforation occurrence were measured. Resection speed was the primary endpoint, and learning curves were evaluated using the Cumulative Sum (CUSUM) method.
Results:
All trainees completed the resection and en-bloc resection of the lesion without any intraoperative perforations. The learning curves covered three phases: initial growth, plateau, and late growth. The transition from phase 1 to phase 2 required a median of 10 sessions. Each trainee completed 30 training sessions in approximately 4 months.
Conclusions
Gastric ESD training using the G-Master is a simple, fast, and effective method for pre-ESD training in clinical practice. It is recommended that at least 10 training sessions be conducted.
4.Real World Data Use in Pharmaceutical Companies in Japan: Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association
Ryo KOTO ; Shinichi ASABE ; Akira ITO ; Kasumi DAIDOJI ; Manabu ISHII ; Kanae TOGO ; Hiroshi MATSUZAWA
Japanese Journal of Pharmacoepidemiology 2024;29(1):15-28
Objective:To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design:Web based-questionnaire surveyMethods:This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results:[Background] Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5%) have “experienced in utilization of RWD”, and 12 (11.8%) have “experienced in considering utilization of RWD”. [Utilization by RWD Type] By data source, hospital-based claim data was the most frequently used (65 cases, 63.7%), followed by insurance-based claim data (61 cases, 59.8%), surveys (38 cases, 37.3%), and EMR (36 cases, 35.3%) in experienced RWD utilization. Conclusion:This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.
5.Real World Data Use in Pharmaceutical Companies in Japan: Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association
Ryo KOTO ; Shinichi ASABE ; Akira ITO ; Kasumi DAIDOJI ; Manabu ISHII ; Kanae TOGO ; Hiroshi MATSUZAWA
Japanese Journal of Pharmacoepidemiology 2024;():29.e2-
Objective:To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design:Web based-questionnaire surveyMethods:This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results:[Background] Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5%) have “experienced in utilization of RWD”, and 12 (11.8%) have “experienced in considering utilization of RWD”. [Utilization by RWD Type] By data source, hospital-based claim data was the most frequently used (65 cases, 63.7%), followed by insurance-based claim data (61 cases, 59.8%), surveys (38 cases, 37.3%), and EMR (36 cases, 35.3%) in experienced RWD utilization. Conclusion:This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.
6.The Details of Inpatient Cancer Rehabilitation Provided by Designated Cancer Hospitals in Japan
Takuya FUKUSHIMA ; Tetsuya TSUJI ; Jiro NAKANO ; Shun ISHII ; Shinsuke SUGIHARA ; Hiroshi SATO ; Juichi KAWAKAMI ; Hitoshi KAGAYA ; Akira TANUMA ; Ryuichi SEKINE ; Keita MORI ; Sadamoto ZENDA ; Akira KAWAI
Palliative Care Research 2023;18(2):143-152
Objective: This study aimed to clarify the details of inpatient cancer rehabilitation interventions provided by designated cancer hospitals in Japan. Methods: This questionnaire-based survey asked specialists regarding the outline of their facilities’ inpatient cancer rehabilitation, Dietz classification, disease, and intervention details. Results: Restorative interventions were the most common, and the most common cancer was lung cancer followed by colorectal cancer; hematologic malignancy; gastric cancer; and liver, gallbladder, and pancreatic cancer. Intervention proportions for colorectal and gastric cancer were significantly higher in general hospitals than in university hospitals and cancer centers; in contrast, those for hematological malignancy were significantly higher in university hospitals than in general hospitals. For bone and soft tissue sarcomas, intervention proportions in cancer centers were significantly higher than those in university and general hospitals; and for oral, pharyngeal, and laryngeal cancers, they were significantly higher in university hospitals and cancer centers than in general hospitals. The most common intervention was walking training, followed by resistance training, basic motor training, activities of daily living training, and respiratory rehabilitation. Respiratory rehabilitation was performed significantly more frequently in university and general hospitals than in cancer centers.Conclusion: The diseases had differed according to the characteristics of the facilities, and the interventions were considered accordingly. In future, it will be necessary to verify the effectiveness of inpatient cancer rehabilitation according to facility characteristics and to disseminate information on inpatient cancer rehabilitation.
7.Postoperative Loss of Lumbar Lordosis Affects Clinical Outcomes in Patients with Pseudoarthrosis after Posterior Lumbar Interbody Fusion Using Cortical Bone Trajectory Screw Fixation
Akira YAMAGISHI ; Hironobu SAKAURA ; Masayoshi ISHII ; Atsunori OHNISHI ; Tetsuo OHWADA
Asian Spine Journal 2021;15(3):294-300
Retrospective cohort study. This study aimed to investigate relationships between clinical outcomes and radiographic parameters in patients with pseudoarthrosis after posterior lumbar interbody fusion (PLIF). In some patients with pseudoarthrosis after PLIF, clinical symptoms improve following surgery, although pseudoarthrosis can often be one of the complications. However, there are no previous reports describing differences between patients with pseudoarthrosis after PLIF who have obtained better clinical outcomes and those who have not. Twenty-seven patients who were diagnosed with pseudoarthrosis after single-level PLIF with cortical bone trajectory screw fixation (CBT-PLIF) were enrolled in this study. They were divided into two groups based on mean improvement of 22 points on the Oswestry Disability Index (ODI) at the 2-year follow-up. Group G consisted of 15 patients who showed improvement on the ODI of ≥22 points, and group P consisted of the residual 12 patients. Radiographic parameters, percentage of slip, lumbar lordosis (LL), segmental lordosis, segmental range of motion, screw loosening, and subsidence were compared between the two groups. There were no significant differences between the two groups on radiographic parameters except for postoperative changes in LL. Although surgery-induced changes in LL showed no significant difference between the two groups, changes in LL from before surgery to 2-year follow-up and during postoperative 2-year follow-up were significantly better in group G (mean change of LL: +3.5° and +5.1°, respectively) compared to group P (mean change of LL: −4.6° and −0.5°, respectively) ( Patients with greater improvement in ODI gained LL over the 2-year follow-up, whereas patients with less improvement in ODI lost LL during the 2-year follow-up. These results indicate that there is a significant correlation between clinical outcomes and LL even in patients with pseudoarthrosis after single-level CBT-PLIF.
8.Postoperative Loss of Lumbar Lordosis Affects Clinical Outcomes in Patients with Pseudoarthrosis after Posterior Lumbar Interbody Fusion Using Cortical Bone Trajectory Screw Fixation
Akira YAMAGISHI ; Hironobu SAKAURA ; Masayoshi ISHII ; Atsunori OHNISHI ; Tetsuo OHWADA
Asian Spine Journal 2021;15(3):294-300
Retrospective cohort study. This study aimed to investigate relationships between clinical outcomes and radiographic parameters in patients with pseudoarthrosis after posterior lumbar interbody fusion (PLIF). In some patients with pseudoarthrosis after PLIF, clinical symptoms improve following surgery, although pseudoarthrosis can often be one of the complications. However, there are no previous reports describing differences between patients with pseudoarthrosis after PLIF who have obtained better clinical outcomes and those who have not. Twenty-seven patients who were diagnosed with pseudoarthrosis after single-level PLIF with cortical bone trajectory screw fixation (CBT-PLIF) were enrolled in this study. They were divided into two groups based on mean improvement of 22 points on the Oswestry Disability Index (ODI) at the 2-year follow-up. Group G consisted of 15 patients who showed improvement on the ODI of ≥22 points, and group P consisted of the residual 12 patients. Radiographic parameters, percentage of slip, lumbar lordosis (LL), segmental lordosis, segmental range of motion, screw loosening, and subsidence were compared between the two groups. There were no significant differences between the two groups on radiographic parameters except for postoperative changes in LL. Although surgery-induced changes in LL showed no significant difference between the two groups, changes in LL from before surgery to 2-year follow-up and during postoperative 2-year follow-up were significantly better in group G (mean change of LL: +3.5° and +5.1°, respectively) compared to group P (mean change of LL: −4.6° and −0.5°, respectively) ( Patients with greater improvement in ODI gained LL over the 2-year follow-up, whereas patients with less improvement in ODI lost LL during the 2-year follow-up. These results indicate that there is a significant correlation between clinical outcomes and LL even in patients with pseudoarthrosis after single-level CBT-PLIF.
9.A Workshop for Care Workers, Nurses and Pharmacists to Identify Problems Related to Cooperation and Propose Solutions to Ensure Appropriate Medication Assistance for NursingHome Residents
Hayato KIZAKI ; Akira SHIRAISHI ; Yuji TORII ; Takayuki ISHII ; Hideyuki MAKI ; Akiko MIKI ; Hiroki SATOH ; Daisuke YAMAMOTO ; Yukari KONISHI ; Kenichi FUNAHASHI ; Yoshinobu USUI ; Satoko HORI ; Yasufumi SAWADA
Japanese Journal of Drug Informatics 2020;22(1):44-52
Objective: In order to ensure the safety of nursing home residents, it is very important to implement appropriate assistance to ensure compliance with necessary medication. The purpose of this study is to identify issues and to plan solutions for medication assistance.Design: We conducted a workshop involving care workers (CWs), nurses and pharmacists together.Methods: Using the KJ method, participants extracted problems related to medication assistance and planned solutions in a mixed group of CWs, nurses and pharmacists. Questionnaire surveys were conducted for the participants before, immediately after, and 3 months after the workshop.Results: A number of important and urgent issues related to medication assistance were identified. There were differences in the recognition patterns of the importance and urgency of the issues among the three categories of participants. In addition, many possible solutions were proposed. Among these solutions, 25% had been implemented by at least two participants. More than 75 % of participants felt that their awareness of the value of cooperation in medication assistance had been improved by participating in the workshop.Conclusion: These results suggest that a workshop with a group of CWs, nurses and pharmacists in one place is a useful approach for extracting problems and planning effective solutions related to cooperation in medication assistance.
10.Improvement of diagnosis of malaria using an innovated LED Light box and microscopy in VanuatuA case report of the field trial and problems
Makoto OWHASHI ; Masato KAWABATA ; Akira ISHII ; George TALEO
Journal of International Health 2010;25(1):41-45
Malaria is a parasitic disease of major health significance that arrests the development of the tropical countries.We assembled an innovated LED light box for diagnosis of malaria, and examined for availability of the LED light box in the clinics of malaria endemic area in Solomon islands in the previous study. In the present study, we tried to use the LED light box for the practical use in the clinics with diagnostic service of malaria in Vanuatu (next country of Solomon Islands) for 1 year, and verified the availability and problems of the continual use of the LED light box.We identified the advantage of the use of LED light box in the diagnosis of malaria using microscopy. On the other hand, additional training of basic electricity is needed for microscopists who have little experience for electronics in the course of training of mictroscopists for the practical use of the LED light box.


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