Background/Aims: Mirikizumab is a p19-directed anti-interleukin-23 antibody with potential efficacy against ulcerative colitis (UC). We evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies. Methods: LUCENT-1 and LUCENT-2 were phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab therapy in adults with moderately to severely active UC. LUCENT-1 was a 12-week induction trial where patients were randomized 3:1 to receive intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W). Patients achieving a clinical response with mirikizumab following the induction study were re-randomized 2:1 to double-blind treatment with either mirikizumab 200 mg or placebo subcutaneously Q4W during the 40-week maintenance study. The primary outcomes were clinical remission at week 12 of LUCENT-1 and week 40 of LUCENT-2. Results: A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Compared with placebo, patients who received mirikizumab showed numerically higher clinical remission at week 12 of induction (32.4% [n = 33] vs. 2.9% [n = 1]) and at week 40 of maintenance (48.9% [n = 23] vs. 28.0% [n = 7]). A greater number of patients achieved key secondary endpoints in the mirikizumab group compared with placebo. The frequency of treatment-emergent adverse events was similar across mirikizumab and placebo groups. Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population. Conclusions Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC. No new safety concerns were identified.

Low-grade epilepsy-associated tumors (LEAT) are brain tumors that should be differentiated as a cause of symptomatic epilepsy in children. The most common initial symptom is epileptic seizure, particularly focal seizures. We present a case of LEAT in which an infant presented to our department with convulsive-like seizures that were observed from approximately 3 months of age. At the first visit, growth and development, including head circumference, were appropriate for age. The seizures were atypical, but ictal video electroencephalography showed abnormal waves indicative of left hemispheric epilepsy. The patient subsequently presented with somnolence and poor feeding, and a sudden increase in head circumference and hydrocephalus were observed. Thus, the patient was urgently admitted to the neurosurgery department of our hospital. Brain MRI showed a suspected brain tumor and elective craniotomy was performed. No epileptic seizures were observed postoperatively. When focal epileptic seizures are observed in infancy, a brain tumor should also be considered as a differential diagnosis, and further examination may be warranted.

Mouthwash is used to support brushing because it is distributed throughout the oral cavity. In this study, we examined the efficacy of a mixture of three hot water extracts (from Hordeum vulgare L, Apocynum venetum L, and Brasenia schreberi J. F. Gmel) for the purpose of developing an effective mouthwash. The mixture suppressed enhanced tumor necrosis factor α and matrix metalloproteinase 3 gene expression by Porphyromonas gingivalis lipopolysaccharide stimulation in human gingival fibroblasts. Furthermore, human studies using a mouthwash containing the plant extracts (MW) improved gingival index and bleeding on probing in the gum, and reduced the concentration of methyl mercaptan, which causes bad breath, in the mouth. These findings suggest that continued use of MW has positive effects on gingival inflammation and halitosis, and is useful for maintaining oral health.

Background/Aims: Many Japanese institutions use electromagnetic extracorporeal shock wave lithotripsy (ESWL) systems for treating pancreatic duct stones. However, there are no reports on direct comparisons between recent electromagnetic lithotripters. This study aimed to verify whether the new electromagnetic lithotripter can improve the efficiency of pancreatic stone fragmentation, and to clarify the role of combined endoscopic treatment on the clearance of pancreatic duct stones. Methods: We retrospectively identified 208 patients with pancreatolithiasis who underwent endoscopic adjunctive treatment after pancreatic ESWL at a single Japanese center over a 17-year period. We evaluated the outcome data of this procedure performed with SLX-F2 (last 2 years; group A) and Lithostar/Lithoskop (first 15 years; group B), as well as additional endoscopic treatments for pancreatolithiasis. We also performed logistic regression analysis to detect various factors associated with the procedure. Results: For pancreatic head stones, ESWL disintegration was achieved in 93.7% of group A patients and 69.0% of group B patients (p=0.004), and adjunctive endoscopic treatment removed stones in 96.8% of group A patients and 73.0% of group B patients (p=0.003). Multivariate analysis revealed that lithotripter type (odds ratio, 6.99; 95% confidence interval, 1.56 to 31.33; p<0.01) and main pancreatic duct stricture (odds ratio, 2.87; 95% confidence interval, 1.27 to 6.45; p<0.01) were significant factors for ESWL fragmentation. Conclusions The SLX F2 showed high performance in fragmenting the pancreatic duct stones.In addition, endoscopic adjunctive treatment improved the overall success rate of the procedure. The improved ESWL lithotripter has many advantages for patients undergoing pancreatic lithotripsy treatment.

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.

Methods: Preoperative CT data from 26 patients pertaining to adult spinal deformities were investigated in this study. We applied a 3D image processing method for a detailed investigation. Virtual cylinders were used to mimic SAI screws. These were placed to penetrate the sacral iliac joint without violating the other cortex. We then assessed the trajectory of the longest SAI screw and the ideal entry point of SAI using a color mapping method on the surface of the sacrum. We measured the location of the nerve root at S1 in relation to the foramen at S1 and the sacral surface. Results: As per the results of our color mapping, it was determined that areas that received high scores are located medially and caudally to the dorsal foramen of S1. The mean angle between a horizontal line and a line connecting the medial edge of the foramen and nerve root at S1 was 93.5°. The mean distances from the dorsal medial edge of the foramen and sacral surface to S1 nerve root were 21.8 mm and 13.9 mm, respectively. Conclusions The ideal entry point of the SAI screw is located medially and caudally to the S1 dorsal foramen based on 3D digital mapping. It is also shown that this entry point spares the S1 nerve root from possible iatrogenic injuries.

Background/Aims: Endoscopic evaluation of intraductal papillary mucinous neoplasms (IPMNs) is useful in determining whether the lesions are benign or malignant. This study aimed to examine the usefulness of peroral pancreatoscopy (POPS) in determining the prognosis of IPMNs. Methods: POPS with videoscopy was performed using the mother–baby scope technique. After surgery, computed tomography/magnetic resonance cholangiopancreatography or ultrasonography and blood tests were performed every 6 months during the follow-up. Results: A total of 39 patients with main pancreatic duct (MPD)–type IPMNs underwent POPS using a videoscope, and the protrusions in the MPD were observed in 36 patients. The sensitivity and specificity of cytology/biopsy performed at the time of POPS were 85% and 87.5%, respectively. Of 19 patients who underwent surgery, 18 (95%) patients had negative surgical margins and 1 (5%) patient had a positive margin. Conclusions In IPMNs with dilatation of the MPD, POPS is considered effective if the lesions can be directly observed. The diagnosis of benign and malignant lesions is possible depending on the degree of lesion elevation. However, in some cases, slightly elevated lesions may increase in size during the follow-up or multiple lesions may be simultaneously present; therefore, careful follow-up is necessary.

Purpose: Preoperative sarcopenia worsens postoperative outcomes in various cancer types including colorectal cancer. However, we often experienced postoperative anastomotic leakage in muscular male patients such as Judo players, especially in rectal cancer surgery with lower anastomosis. It is controversial whether the whole skeletal muscle mass impacts the potential for anastomotic failure in male rectal cancer patients. Thus, the purpose of this study was to clarify whether skeletal muscle mass impacts anastomotic leakage in rectal cancer in men. Methods: We reviewed the medical charts of male patients suffering from rectal cancer who underwent colo-procto anastomosis below the peritoneal reflection without a protective diverting stoma. We measured the psoas muscle area and calculated the psoas muscle index. Results: One hundred ninety-seven male rectal cancer patients were enrolled in this study. The psoas muscle index was significantly higher in patients with anastomotic leakage (P<0.001). Receiver operating characteristic curve determined the optimal cut-off value of the psoas muscle index for predicting anastomotic leakage as 812.67 cm2/m2 (sensitivity of 60% and specificity of 74.3%). Multivariate analysis revealed that high psoas muscle index (risk ratio [RR], 3.933; P<0.001; 95% confidence interval [CI], 1.917–8.070) and super low anastomosis (RR, 2.792; P=0.015; 95% CI, 1.221–6.384) were independent predictive factors of anastomotic leakage. Conclusion This study showed that male rectal cancer patients with a large psoas muscle mass who underwent lower anastomosis had a higher rate of postoperative anastomotic leakage.

Objective: Lenvatinib is an oral multitarget tyrosine kinase inhibitor (mTKI) and is recommended for patients with advanced hepatocellular carcinoma (HCC) with Child-Pugh A liver function, who are not amenable to surgical resection, locoregional treatment, or transcatheter arterial chemoembolization. Hepatogastric fistula is a rare complication with a poor prognosis in patients with HCC. Previous reports on fistula formation during mTKI therapy for HCC were all associated with sorafenib. Here, we report the first case of recurrent hepatogastric fistula during lenvatinib therapy for advanced HCC managed using an over-the-scope clip (OTSC).Patient: We present the case of a 73-year-old man with alcoholic liver cirrhosis who was treated for multiple HCC for 7 years. HCC was treated using repetitive transcatheter arterial chemoembolization, radiofrequency ablation, and sorafenib. Owing to disease progression, lenvatinib treatment was started. During lenvatinib treatment, recurrent hepatogastric fistulas developed. An OTSC was useful for fistula closure and prevention of recurrence.Results: The major cause of fistula formation is considered to be the direct invasion of HCC; however, HCC treatment might also be a contributing factor in our case. In addition, OTSC was useful for fistula closure.Conclusion: Clinicians should be aware of the fatal complications during HCC treatment.