At the 73rd Academic Conference of the Japan Society for Oriental Medicine held in June 2023, a report on an establishment of evidence for the coronavirus disease-2019 (COVID-19) was presented. As part of this project, we reported how we conducted the observational study and the clinical trial that evaluated the effectiveness of Kampo medicine on the acute symptoms of mild to moderate COVID-19 patients. In this article, we have summarized our experience in these studies from the viewpoint of a statistician, including important things to be considered when writing a research plan and selecting endpoints and statistical analysis methods.

Background/Aims: Hepatobiliary scintigraphy (HBS) is used to evaluate bile excretion. This study aimed to evaluate biliary excretion during endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) using HBS. Methods: We retrospectively evaluated 78 consecutive patients with malignant extrahepatic biliary obstruction, who underwent HBS after EUS-HGS between April 2015 and July 2022. The peak time and decay rate were scored with 0, 1, or 2 points based on thresholds of 20 and 35 minutes, and 10% and 50%, respectively. A total score of 4 or 3 was considered indicative of good bile excretion, whereas scores of 2, 1, or 0 indicated poor bile excretion. Results: The good and poor bile excretion groups included 40 and 38 cases, respectively. The group with good bile excretion had a significantly longer time to recurrent biliary obstruction compared to the poor bile excretion group (not reached vs. 124 days, p=0.026). Multivariate analysis identified the site of obstruction as a significant factor influencing good bile excretion (odds ratio, 3.39; 95% confidence interval, 1.01–11.4, p=0.049), with superior bile excretion observed in cases involving upper biliary obstruction compared to middle or lower biliary obstruction. Conclusions In patients with malignant biliary obstruction who underwent HGS, the site of obstruction is significantly associated with stent patency.

Background/Aims: Hepatobiliary scintigraphy (HBS) is used to evaluate bile excretion. This study aimed to evaluate biliary excretion during endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) using HBS. Methods: We retrospectively evaluated 78 consecutive patients with malignant extrahepatic biliary obstruction, who underwent HBS after EUS-HGS between April 2015 and July 2022. The peak time and decay rate were scored with 0, 1, or 2 points based on thresholds of 20 and 35 minutes, and 10% and 50%, respectively. A total score of 4 or 3 was considered indicative of good bile excretion, whereas scores of 2, 1, or 0 indicated poor bile excretion. Results: The good and poor bile excretion groups included 40 and 38 cases, respectively. The group with good bile excretion had a significantly longer time to recurrent biliary obstruction compared to the poor bile excretion group (not reached vs. 124 days, p=0.026). Multivariate analysis identified the site of obstruction as a significant factor influencing good bile excretion (odds ratio, 3.39; 95% confidence interval, 1.01–11.4, p=0.049), with superior bile excretion observed in cases involving upper biliary obstruction compared to middle or lower biliary obstruction. Conclusions In patients with malignant biliary obstruction who underwent HGS, the site of obstruction is significantly associated with stent patency.

Background/Aims: Hepatobiliary scintigraphy (HBS) is used to evaluate bile excretion. This study aimed to evaluate biliary excretion during endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) using HBS. Methods: We retrospectively evaluated 78 consecutive patients with malignant extrahepatic biliary obstruction, who underwent HBS after EUS-HGS between April 2015 and July 2022. The peak time and decay rate were scored with 0, 1, or 2 points based on thresholds of 20 and 35 minutes, and 10% and 50%, respectively. A total score of 4 or 3 was considered indicative of good bile excretion, whereas scores of 2, 1, or 0 indicated poor bile excretion. Results: The good and poor bile excretion groups included 40 and 38 cases, respectively. The group with good bile excretion had a significantly longer time to recurrent biliary obstruction compared to the poor bile excretion group (not reached vs. 124 days, p=0.026). Multivariate analysis identified the site of obstruction as a significant factor influencing good bile excretion (odds ratio, 3.39; 95% confidence interval, 1.01–11.4, p=0.049), with superior bile excretion observed in cases involving upper biliary obstruction compared to middle or lower biliary obstruction. Conclusions In patients with malignant biliary obstruction who underwent HGS, the site of obstruction is significantly associated with stent patency.

Methods: Radiological parameters were extracted from the whole lateral radiographs. Patients were divided into two groups: the ASD group (segmental kyphosis of ≥10º, and/or a ≥50% loss of disc height, and/or ≥3 mm of anteroposterior translation) and the non-ASD group. Results: All 112 included patients underwent PLIF for lumbar degenerative diseases. The minimum follow-up period was 2 years, with an average follow-up time of 63.6 months. Fifty-two patients (46.4%) were classified into the ASD group and of these, 13 required reoperation due to failure of conservative treatment. Patients with ASD exhibited significantly more caudal and posterior inflection vertebrae (IV), while the lumbar apical vertebra was significantly more caudal immediately after surgery. The IV position was identified as a significant risk factor for ASD, and the ASD incidence was significantly higher in the group where IV ≤5 (L1 vertebral body) than in the group where IV ≥5.5 (T12–L1 disc) (69.0% vs. 38.6%). Conclusions The IV position is a significant risk factor for ASD development. Although it is difficult to control intraoperative IV levels, we note a high risk of ASD in patients with IV lower than T12–L1.

Background/Aims: Endoscopic ultrasound (EUS)-guided hepaticogastrostomy (EUS-HGS) performed at the intrahepatic bile duct segment 3 (B3) is widely used for biliary drainage. Although performing post-puncture procedures is easier in the intrahepatic bile duct segment 2 (B2) when using a conventional oblique-viewing (OV) EUS scope, this method may cause transesophageal puncture and severe adverse events. We evaluated the safety and efficacy of B2 puncture using a novel OV-EUS scope. Methods: In this single-center retrospective study, we prospectively enrolled and collected data from 45 patients who consecutively underwent EUS-HGS procedures with a novel OV-EUS scope between September 2021 and December 2022 at our cancer center. Results: The technical success rates of B2-EUS-HGS and EUS-HGS were 93.3% (42/45) and 97.8% (44/45), respectively. The early adverse event rate was 8.9% (4/45) with no cases of scope changes or transesophageal punctures. The median procedure time was 13 minutes (range, 5–30). Conclusions B2-EUS-HGS can be performed safely with the novel EG-740UT (Fujifilm) OV-scope without transesophageal puncture and with a high success rate. B2-EUS-HGS using this novel OV scope may be the preferred strategy for EUS-HGS.

Background/Aims: Endoscopic ultrasound (EUS)-guided hepaticogastrostomy (EUS-HGS) is useful for patients with biliary cannulation failure or inaccessible papillae. However, it can lead to serious complications such as bile peritonitis in patients with ascites; therefore, development of a safe method to perform EUS-HGS is important. Herein, we evaluated the safety of EUS-HGS with continuous ascitic fluid drainage in patients with ascites. Methods: Patients with moderate or severe ascites who underwent continuous ascites drainage, which was initiated before EUS-HGS and terminated after the procedure at our institution between April 2015 and December 2022, were included in the study. We evaluated the technical and clinical success rates, EUS-HGS-related complications, and feasibility of re-intervention. Results: Ten patients underwent continuous ascites drainage, which was initiated before EUS-HGS and terminated after completion of the procedure. Median duration of ascites drainage before and after EUS-HGS was 2 and 4 days, respectively. Technical success with EUS-HGS was achieved in all 10 patients (100%). Clinical success with EUS-HGS was achieved in 9 of the 10 patients (90 %). No endoscopic complications such as bile peritonitis were observed. Conclusions In patients with ascites, continuous ascites drainage, which is initiated before EUS-HGS and terminated after completion of the procedure, may prevent complications and allow safe performance of EUS-HGS.

Background/Aims: Endoscopic ultrasound-guided tissue acquisition (EUS-TA) is a standard diagnostic method for biliary tract cancer (BTC), and samples obtained in this manner may be used for comprehensive genomic profiling (CGP). This study evaluated the utility of EUS-TA for CGP in a clinical setting and determined the factors associated with the adequacy of CGP in patients with BTC. Methods: CGP was attempted for 105 samples from 94 patients with BTC at the Aichi Cancer Center, Japan, from October 2019 to April 2022. Results: Overall, 77.1% (81/105) of the samples were adequate for CGP. For 22-G or 19-G fine-needle biopsy (FNB), the sample adequacy was 85.7% (36/42), which was similar to that of surgical specimens (94%, p=0.45). Univariate analysis revealed that 22-G or larger FNB needle usage (86%, p=0.003), the target primary lesions (88%, p=0.015), a target size ≥30 mm (100%, p=0.0013), and number of punctures (90%, p=0.016) were significantly positively associated with CGP sample adequacy. Conclusions EUS-TA is useful for CGP tissue sampling in patients with BTC. In particular, the use of 22-G or larger FNB needles may allow for specimen adequacy comparable to that of surgical specimens.

Background/Aims: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly accurate method for diagnosing pancreatic neuroendocrine tumors (PNETs); however, some PNETs are difficult to diagnose. Recently, the efficacy of needle-based confocal laser endomicroscopy (nCLE) in diagnosing solid pancreatic masses has been reported. However, the efficacy of nCLE in the diagnosis of PNETs remains unknown and only a small number of cases have been reported. Hence, this study aimed to evaluate the efficacy of nCLE in the diagnosis of PNETs. Methods: This single-center retrospective study evaluated 30 consecutive patients with suspected PNETs on contrast-enhanced computed tomography, who consented to nCLE combined with EUS-FNA and were diagnosed using EUS-FNA or surgical resection. The diagnostic criteria for PNETs using nCLE were based on the nesting and trabecular and glandular arrangement of tumor cell clusters surrounded by capillary vessels and fibrosis, as reported in previous studies. Results: The diagnosis using nCLE was classified into three categories: misdiagnosis in three cases (10%), non-diagnostic in six cases (20%), and diagnostic in 21 cases (70%). nCLE was able to diagnose PNET in one of the two cases with inconclusive EUS-FNA. Conclusions Although further development of the resolution and optimization of the diagnostic criteria are required, nCLE may constitute a useful diagnostic option in cases of inconclusive EUS-FNA for PNETs.

Objectives: Locomotive syndrome stage 3 (LS3), which has been established recently, may imply a greater need for care than LS stage 0 (LS0), LS stage 1 (LS1), and LS stage 2 (LS2). The relationship between LS3 and long-term care in Japan is unclear. Therefore, this study aimed to examine this relationship. Methods: A total of 531 patients (314 women and 217 men; mean age, 75 years) who were not classified as requiring long-term care and underwent musculoskeletal examinations in 2012 were grouped according to their LS stage. Group L comprised patients with LS3 and Group N comprised those with LS0, LS1, and LS2. We compared these groups according to their epidemiology results and long-term care requirements from 2013 to 2018. Results: Fifty-nine patients (11.1%) were diagnosed with LS3. Group L comprised more patients (50.8%) who required long-term care than Group N (17.8%) (P < 0.001). Group L also comprised more patients with vertebral fractures and knee osteoarthritis than Group N (33.9% vs 19.5% [P = 0.011] and 78% vs 56.4% [P < 0.001], respectively). A Cox proportional hazards model and Kaplan–Meier analysis revealed a significant difference in the need for nursing care between Groups L and N (log-rank test, P < 0.001; hazard ratio, 2.236; 95% confidence interval, 1.451–3.447). Conclusions Between 2012 and 2018, 50% of patients with LS3 required nursing care. Therefore, LS3 is a highrisk condition that necessitates interventions. Approaches to vertebral fractures and osteoarthritis of the knee could be key.