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.

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.

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.

Background: Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy. Methods This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.

Background: Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy. Methods This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.

Background: Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy. Methods This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.

Objective: This study aimed to investigate the feasibility of a patient registry system for assessing PCT (palliative care team) by PRO (Patient-reported outcome) in Japan. Methods: We operated a patient registry system with electronic data collection at eight hospitals in 2021 in Japan. We consecutively included newly referred patients for a month and followed up with them for a month. IPOS or ESAS obtained as PRO at the start of the intervention, three days later, and every week after. The primary endpoint was the response rate to the symptom rating scale by patients and providers. Results: 318 patients were enrolled. The patient response rate was 59.1% at intervention and 37.0% after intervention, and the medical provider response rate was 98.4% at intervention and 70.3% after intervention. Interviews with PCT members indicated that participants required support to input PRO responses required support and paper questionnaire was better and that managing the survey date and overall management was burdensome. Discussion: Although only about half of the patients were able to respond to the PRO, this was the same level as in previous studies. The system and its operation method have many problems. We found that improvements such as reducing items and making the patient interviews paper-based are necessary to expand the system nationwide.

Objective: The use of direct oral anticoagulants (DOACs) has increased because they have some advantages over warfarin, such as fewer interactions and no requirement for coagulation monitoring in principle. DOACs have dose adjustment requirement based on renal function and other complex criteria that differ depending on specific DOAC preparations and indications. At the Nagoya City East Medical Center, DOAC dose‒related decisions previously depended on the knowledge and discretion of individual pharmacists. However, a dose checking sheet for DOACs (the Checking Sheet) was prepared and used on our electronic medical record system since September 2016 to increase the reliability of prescription checking, eliminate improper prescriptions, and ensure electronic documentation of pharmaceutical inquiries. In this study, we compared percentages of proper prescriptions before and after the introduction of the Checking Sheet to assess the effectiveness of its use, which has not been reported previously.Method: The percentage of proper DOAC prescriptions was used as a measure to assess the effectiveness of the Checking Sheet. We investigated DOAC prescriptions from March 2017, when the Checking Sheet system had been established, and compared those with prescriptions from March 2016 (before the Checking Sheet was introduced). Prescriptions of rivaroxaban, apixaban, edoxaban, and dabigatran for nonvalvular atrial fibrillation or venous thromboembolism were included; prescriptions dispensed outside the hospital were excluded.Result: DOAC prescriptions before and after the Checking Sheet introduction were similar in number. The percentage of proper prescriptions increased significantly from 82.4 to 94.3%. Among specific DOAC preparations, the number of improper prescriptions decreased significantly for apixaban and showed a tendency to decrease for rivaroxaban.Conclusion: The increases in the number of proper DOAC prescriptions observed after introducing the Checking Sheet showed that the Checking Sheet helped ensure a certain level of prescription checking, suggesting its usefulness for promoting proper DOAC use.

Behçet’s disease (BD) is a multisystem inflammatory disease of unknown origin. Rarely, BD occurs together with myelodysplastic syndrome (MDS). Interestingly, it is speculated that these are not simple coexistence but that the etiology of intestinal BD is at least partly derived from MDS itself. Furthermore, there is a relationship between MDS in patients with intestinal BD and trisomy 8. Immunosuppressive agents alone are insufficient to control MDS-associated BD, and many of these patients die of infection or hemorrhage. Surgery is considered for intestinal BD patients who are unresponsive to medical treatment or those with bowel complications such as perforation or persistent bleeding. We report a case of intestinal BD associated with MDS and trisomy 8. The patient was unresponsive to oral steroids and immunosuppressive treatment; the patient improved by surgical repair of a bowel perforation. Five years after the surgery, the patient is free of recurrence and not on medication. Our experience suggests that surgery may provide an effective therapeutic option for the treatment of MDS-related BD.

BACKGROUND/AIMS: Recent genome-wide analyses have provided strong evidence concerning adverse events caused by thiopurine drugs such as azathioprine (AZA) and 6-mercaptopurine. The strong associations identified between NUDT15 p.Arg139Cys and thiopurine-induced leukopenia and severe hair loss have been studied and confirmed over the last 2 years. However, other coding variants, including NUDT15 p.Val18_Val19insGlyVal, NUDT15 p.Val18Ile, and FTO p.Ala134Thr, and a noncoding variation in RUNX1 (rs2834826) remain to be examined in detail in this respect. Therefore, we investigated the correlation between these adverse events and the 5 recently identified variants mentioned above among Japanese patients with inflammatory bowel diseases (IBD). METHODS: One hundred sixty thiopurine-treated patients with IBD were enrolled. Genotyping was performed using TaqMan SNP Genotyping Assays or Sanger sequencing. RESULTS: None of the 5 variants were associated with gastrointestinal intolerance to AZA. However, NUDT15 p.Arg139Cys was significantly associated with the interval between initiation and discontinuation of AZA among patients with gastrointestinal intolerance. This variant was strongly associated with early (<8 weeks) and late (≥8 weeks) leukopenia and severe hair loss. Moreover, it correlated with the interval between initiation of thiopurine therapy and leukopenia occurrence, and average thiopurine dose. NUDT15 p.Val18_Val19insGlyVal, NUDT15 p.Val18Ile, FTO p.Ala134Thr, and RUNX1 rs2834826 exhibited no significant relationship with the adverse events examined. CONCLUSIONS: Of the 5 variants investigated, NUDT15 p.Arg139Cys had the strongest impact on thiopurine-induced leukopenia and severe hair loss; therefore, its genotyping should be prioritized over that of other variants in efforts to predict these adverse events in Japanese patients with IBD.
6-Mercaptopurine ; Asian Continental Ancestry Group* ; Azathioprine ; Clinical Coding ; Hair ; Humans ; Inflammatory Bowel Diseases* ; Leukopenia