Background/Aims: The incidence of perianal lesions (PL) in children with Crohn’s disease (CD) is higher in East Asia than in Western countries. Early intervention for PL is essential to prevent sphincter dysfunction and ostomy placement. In this study, we aimed to investigate the clinical features, treatment, and consequences of pediatric CD with PL. Methods: We retrospectively reviewed a cohort of children diagnosed with CD from 2010 to 2020 at a Japanese children’s hospital. Demographics, treatments, and outcomes were evaluated and compared among subgroups. Results: Among 112 pediatric patients with CD, 36 (32.1%) had experienced PL during the observational period. The median ages at diagnosis and follow-up periods were 131 and 70 months, respectively. Six (85.7%) patients in the very early-onset (VEO) group (CD diagnosed before 6 years old) and 24 (82.8%) in the older age group had PL upon diagnosis of CD (P= 0.851). Biologics were given to 94.4% of patients: infliximab (67.7%), adalimumab (58.8%), ustekinumab (44.1%), risankizumab (11.8%), and vedolizumab (5.9%). Biologics were introduced within 1 year in 89.5% and 40.0% of patients diagnosed in 2016–2020 and 2010–2016, respectively (P= 0.002). Seton was frequently used in the older age group (87.5 vs. 42.9%, P= 0.190). Ostomy was frequently required in the VEO group (42.9% vs. 0.0%, P= 0.006). Conclusions Patients with VEO-CD and PL had a notably high risk of ostomy placement. The earlier introduction of biologics and surgical interventions reduced corticosteroids use and ostomy placement in pediatric CD patients with PL.

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.

Objective: To implement early rehabilitation interventions by physical therapists is recommended. However, the effectiveness of early rehabilitation for severe coronavirus disease 2019 (COVID-19) patients in the prevention of post-intensive care syndrome (PICS) is unclear. We analyzed a multicenter prospective observational study (Post-Intensive Care outcomeS in patients with COronaVIrus Disease 2019) to examine the association between early rehabilitation interventions and PICS physical impairment. Methods: An analysis was performed on COVID-19 patients who were admitted to intensive care units (ICUs) between March 2020 and March 2021, and required mechanical ventilation. The primary outcome was the incidence of PICS physical impairment (Barthel Index≤90) after one year. Multivariate logistic regression analysis was used to estimate the association between early rehabilitation interventions and PICS physical impairment by adjusting ICU mobility scale (IMS) during seven-day following ICU admission, and clinically relevant risk factors. Results: The analysis included 259 patients, 54 of whom developed PICS physical impairment one year later. In 81 patients, physical therapists intervened within seven days of ICU admission. There was no significant difference in mean IMS by day seven of admission between the early and non-early rehabilitation patients (0.70 and 0.61, respectively). Multivariate logistic regression analysis showed that early rehabilitation interventions were significantly associated with a low incidence of PICS physical impairment (odds ratio, 0.294; 95% confidence interval, 0.123–0.706; p=0.006). Conclusion Early rehabilitation interventions by physical therapists were an independent factor associated with the decreased development of PICS physical impairment at one year, even though early rehabilitation had no significant effect on IMS.

Objective: To implement early rehabilitation interventions by physical therapists is recommended. However, the effectiveness of early rehabilitation for severe coronavirus disease 2019 (COVID-19) patients in the prevention of post-intensive care syndrome (PICS) is unclear. We analyzed a multicenter prospective observational study (Post-Intensive Care outcomeS in patients with COronaVIrus Disease 2019) to examine the association between early rehabilitation interventions and PICS physical impairment. Methods: An analysis was performed on COVID-19 patients who were admitted to intensive care units (ICUs) between March 2020 and March 2021, and required mechanical ventilation. The primary outcome was the incidence of PICS physical impairment (Barthel Index≤90) after one year. Multivariate logistic regression analysis was used to estimate the association between early rehabilitation interventions and PICS physical impairment by adjusting ICU mobility scale (IMS) during seven-day following ICU admission, and clinically relevant risk factors. Results: The analysis included 259 patients, 54 of whom developed PICS physical impairment one year later. In 81 patients, physical therapists intervened within seven days of ICU admission. There was no significant difference in mean IMS by day seven of admission between the early and non-early rehabilitation patients (0.70 and 0.61, respectively). Multivariate logistic regression analysis showed that early rehabilitation interventions were significantly associated with a low incidence of PICS physical impairment (odds ratio, 0.294; 95% confidence interval, 0.123–0.706; p=0.006). Conclusion Early rehabilitation interventions by physical therapists were an independent factor associated with the decreased development of PICS physical impairment at one year, even though early rehabilitation had no significant effect on IMS.

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.

Objective: To implement early rehabilitation interventions by physical therapists is recommended. However, the effectiveness of early rehabilitation for severe coronavirus disease 2019 (COVID-19) patients in the prevention of post-intensive care syndrome (PICS) is unclear. We analyzed a multicenter prospective observational study (Post-Intensive Care outcomeS in patients with COronaVIrus Disease 2019) to examine the association between early rehabilitation interventions and PICS physical impairment. Methods: An analysis was performed on COVID-19 patients who were admitted to intensive care units (ICUs) between March 2020 and March 2021, and required mechanical ventilation. The primary outcome was the incidence of PICS physical impairment (Barthel Index≤90) after one year. Multivariate logistic regression analysis was used to estimate the association between early rehabilitation interventions and PICS physical impairment by adjusting ICU mobility scale (IMS) during seven-day following ICU admission, and clinically relevant risk factors. Results: The analysis included 259 patients, 54 of whom developed PICS physical impairment one year later. In 81 patients, physical therapists intervened within seven days of ICU admission. There was no significant difference in mean IMS by day seven of admission between the early and non-early rehabilitation patients (0.70 and 0.61, respectively). Multivariate logistic regression analysis showed that early rehabilitation interventions were significantly associated with a low incidence of PICS physical impairment (odds ratio, 0.294; 95% confidence interval, 0.123–0.706; p=0.006). Conclusion Early rehabilitation interventions by physical therapists were an independent factor associated with the decreased development of PICS physical impairment at one year, even though early rehabilitation had no significant effect on IMS.

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.

To improve the quality of palliative care in the Kyoto region, we thought that closely connecting hospice and palliative care units (PCU) is necessary. Subsequently, we established the Kyoto PCU Liaison Committee in September 2017. This committee was created as a place to casually discuss the problems that individual PCU facilities have, deliberate on their worries together, grow and develop, and support newly launched facilities. Furthermore, discussions were held on current topics (emergency hospitalization, blood transfusion, smoking, bereaved family meetings, etc.) at the liaison meetings. While meetings were adjourned in 2020 due to the COVID-19 pandemic, we continued to exchange opinions on infection control, PCU management, etc., using the email network at first. Later, these meetings resumed via web conference systems. Thus, by having face-to-face relationships on a daily basis, we were able to maintain cooperation between PCUs even during the pandemic, and collaborate with cancer treatment hospitals. Overall, by forming a team of PCUs in Kyoto Prefecture, we aim to enable patients and their families to live with peace of mind wherever they are.

BACKGROUND/AIMS: Although daclatasvir with asunaprevir was approved in Japan for interferon ineligible or intolerant patients, patients aged ≥75 years were excluded in the phase III trial. The present study aimed to evaluate the safety and efficacy of this therapy for elderly patients aged ≥75 years and to clarify whether an extremely high sustained virological response (SVR) rate can be achieved, even in a real-world setting when patients with resistance-associated substitutions (RASs) to nonstructural protein 5A (NS5A) inhibitors or prior simeprevir failure are excluded. METHODS: Daclatasvir (60 mg) and asunaprevir (100 mg) were orally administered daily for 24 weeks. Patients without pre-existing NS5A RASs and simeprevir failure were enrolled in this study. RESULTS: Overall, 110 patients were treated. The median age was 73 years old. The SVR rates of total patients, those aged ≥75 years, and those aged < 75 years were 97% (107/110), 98% (46/47), and 97% (61/63), respectively. The treatment of two patients (2%) was discontinued because of adverse events. CONCLUSIONS: Daclatasvir with asunaprevir was a safe treatment, even in patients aged ≥75 years. When patients without pre-existing NS5A RASs and prior simeprevir failure were selected, an extremely high SVR rate could be achieved irrespective of age.
Aged ; Hepacivirus ; Humans ; Interferons ; Japan ; Simeprevir

BACKGROUND/AIMS: The present study aimed to evaluate the safety and efficacy of simeprevir-based triple therapy with reduced doses of pegylated interferon (PEG-IFN) and ribavirin for interferon (IFN) ineligible patients, such as elderly and/or cirrhotic patients, and to elucidate the factors contributing to a sustained virologic response (SVR). METHODS: One hundred IFN ineligible patients infected with genotype 1b hepatitis C virus (HCV) were treated. Simeprevir (100 mg) was given orally together with reduced doses of PEG-IFN-α 2a (90 μg), and ribavirin (200 mg less than the recommended dose). RESULTS: The patients’ median age was 70 years, and 70 patients were cirrhotic. Three patients (3%) discontinued treatment due to adverse events. The SVR rate was 64%. Factors that significantly contributed to the SVR included the γ-glutamyl transferase and α-fetoprotein levels, interleukin-28B (IL28B) polymorphism status, and the level and reduction of HCV RNA at weeks 2 and 4. The multivariate analysis showed that the IL28B polymorphism status was the only independent factor that predicted the SVR, with a positive predictive value of 77%. CONCLUSIONS: Simeprevir-based triple therapy with reduced doses of PEG-IFN and ribavirin was safe and effective for IFN ineligible patients infected with genotype 1b HCV. IL28B polymorphism status was a useful predictor of the SVR.
Aged ; Genotype* ; Hepacivirus* ; Hepatitis C* ; Hepatitis* ; Humans ; Interferons* ; Multivariate Analysis ; Ribavirin* ; RNA ; Simeprevir ; Transferases