Objective: DUO-E/GOG-3041/ENGOT-EN10 (NCT04269200) demonstrated statistically significant and clinically meaningful progression-free survival (PFS) improvement with durvalumab plus carboplatin/paclitaxel, followed by durvalumab with or without olaparib, vs. carboplatin/paclitaxel alone (intention-to-treat [ITT] population) in patients with newly diagnosed advanced or recurrent endometrial cancer. We evaluated efficacy and safety in the Japan subset of DUO-E. Methods: Patients with newly diagnosed International Federation of Gynecology and Obstetrics stage III/IV or recurrent endometrial cancer were randomized 1:1:1 to control arm (carboplatin/paclitaxel + durvalumab placebo [6 cycles] followed by durvalumab placebo + olaparib placebo), durvalumab arm (carboplatin/paclitaxel + durvalumab [1,120 mg every 3 weeks] [6 cycles] followed by durvalumab [1,500 mg every 4 weeks] + olaparib placebo), or durvalumab + olaparib arm (carboplatin/paclitaxel + durvalumab [6 cycles] followed by durvalumab + olaparib [300 mg twice a day]). Dual primary endpoints were investigatorassessed PFS for durvalumab and durvalumab + olaparib arms vs. control. This prespecified exploratory analysis evaluated PFS and safety in the Japan subset. Results: In the Japan subset (n=88) PFS favored durvalumab (hazard ratio=0.61, 95% confidence interval [CI]=0.32–1.12) and durvalumab + olaparib (0.44, 95% CI=0.22–0.85) vs. control; median PFS was 9.9 and 15.1 vs. 9.5 months, and the 18-month PFS rate was 37.0% and 42.1% vs. 22.2%, respectively. The safety profile in the Japan subset was generally consistent with the full safety analysis set and the established profiles of the individual agents. Conclusion Efficacy and safety in the Japan subset were generally consistent with outcomes in the DUO-E ITT population. This Japanese subset analysis of DUO-E supports carboplatin/ paclitaxel + durvalumab followed by durvalumab with or without olaparib as new treatment options in patients with advanced or recurrent endometrial cancer and is the first to report on these regimens in Japanese patients alone.

The transcatheter left atrial appendage occluding device, WATCHMAN, can be used to prevent thromboembolism in patients with nonvalvular atrial fibrillation who are at high risk of bleeding during anticoagulation. We report an emergent surgical case of cardiac tamponade due to the left atrial appendage perforation with the WATCHMAN device implantation. An 83-year-old woman with recurrent paroxysmal atrial fibrillation (CHA2DS2-VASc score 4, HAS-BLED score 3) after catheter ablation was scheduled for the WATCHMAN device implantation. During implantation, the patient developed cardiac tamponade and underwent emergent surgery with cardiopulmonary bypass for active bleeding despite pericardial drainage. The bleeding was caused by the left atrial appendage perforation, and suture exclusion of the left atrial appendage was performed.

The case is that of a 90-years-old man. A previous doctor performed abdominal graft replacement for an abdominal aortic aneurysm 5 years earlier and continued outpatient CT follow-up. Follow-up CT showed the right aortic arch and dilation of the thoracic aortic aneurysm, and the patient was referred to our hospital. Contrast-enhanced CT showed an aortic arch aneurysm ; the aneurysm diameter was 62 mm in major axis and 60 mm in minor axis, which was judged to be suitable for surgery. It was a rare right-sided aortic arch with no congenital heart malformation and no situs inversus. Endovascular treatment was considered because he was 90 years old and very elderly, but there were concerns about the risk of embolism, irregular manipulation and central landing. For the surgical method, we selected total arch replacement using a frozen elephant trunk technique. We succeeded in avoiding serious complications by selecting an appropriate treatment method through careful evaluation.

Background/Aims: Esophageal motility disorders (EMDs) contribute to the pathophysiology of gastroesophageal reflux disease. However, the causes of EMDs and their impact on gastroesophageal reflux disease-associated symptoms remain unknown. This study aims to elucidate clinical features associated with various types of EMDs in patients with heartburn symptoms. Methods: Of the 511 patients who underwent high-resolution manometry, 394 who were evaluated for heartburn symptoms were examined. Patients subjected to high-resolution manometry were classified into 4 groups: outflow obstruction group, hypermotility group, hypomotility group, and normal motility group. Symptoms were evaluated using 3 questionnaires. Patient characteristics and symptoms for each EMD type were compared with those of the normal motility group. Results: Of the 394 patients, 193 (48.9%) were diagnosed with EMDs, including 71 with outflow obstruction, 15 with hypermotility, and 107 with hypomotility. The mean dysphagia score was significantly higher in each of the 3 EMD groups compared with those with normal motility. The mean acid reflux and dyspepsia scores were significantly lower in the outflow obstruction group (P < 0.05). The mean body mass index and median Brinkman index were significantly higher in the hypermotility group (P = 0.001 and P = 0.018, respectively), whereas the mean diarrhea and constipation scores were significantly lower in the hypomotility group (P < 0.05). Conclusions The results of our study indicate that different EMDs have distinct characteristics. Cigarette smoking and high body mass index were associated with esophageal hypermotility. Assessment of the dysphagia symptom scores may help identify patients with EMDs.

Background/Aims: Esophageal motility disorders (EMDs) contribute to the pathophysiology of gastroesophageal reflux disease. However, the causes of EMDs and their impact on gastroesophageal reflux disease-associated symptoms remain unknown. This study aims to elucidate clinical features associated with various types of EMDs in patients with heartburn symptoms. Methods: Of the 511 patients who underwent high-resolution manometry, 394 who were evaluated for heartburn symptoms were examined. Patients subjected to high-resolution manometry were classified into 4 groups: outflow obstruction group, hypermotility group, hypomotility group, and normal motility group. Symptoms were evaluated using 3 questionnaires. Patient characteristics and symptoms for each EMD type were compared with those of the normal motility group. Results: Of the 394 patients, 193 (48.9%) were diagnosed with EMDs, including 71 with outflow obstruction, 15 with hypermotility, and 107 with hypomotility. The mean dysphagia score was significantly higher in each of the 3 EMD groups compared with those with normal motility. The mean acid reflux and dyspepsia scores were significantly lower in the outflow obstruction group (P < 0.05). The mean body mass index and median Brinkman index were significantly higher in the hypermotility group (P = 0.001 and P = 0.018, respectively), whereas the mean diarrhea and constipation scores were significantly lower in the hypomotility group (P < 0.05). Conclusions The results of our study indicate that different EMDs have distinct characteristics. Cigarette smoking and high body mass index were associated with esophageal hypermotility. Assessment of the dysphagia symptom scores may help identify patients with EMDs.

OBJECTIVE: We aimed to propose a set of quality indicators (QIs) based on the clinical guidelines for cervical cancer treatment published by The Japan Society of Gynecologic Oncology, and to assess adherence to standard-of-care as an index of the quality of care for cervical cancer in Japan. METHODS: A panel of clinical experts devised the QIs using a modified Delphi method. Adherence to each QI was evaluated using data from a hospital-based cancer registry of patients diagnosed in 2013, and linked with insurance claims data, between October 1, 2012, and December 31, 2014. All patients who received first-line treatment at the participating facility were included. The QI scores were communicated to participating hospitals, and additional data about the reasons for non-adherence were collected. RESULTS: In total, 297 hospitals participated, and the care provided to 15,163 cervical cancer patients was examined using 10 measurable QIs. The adherence rate ranged from 50.0% for ‘cystoscope or proctoscope for stage IVA’ to 98.8% for ‘chemotherapy using platinum for stage IVB’. Despite the variation in care, hospitals reported clinically valid reasons for more than half of the non-adherent cases. Clinically valid reasons accounted for 75%, 90.9%, 73.4%, 44.5%, and 88.1% of presented non-adherent cases respectively. CONCLUSION: Our study revealed variations in pattern of care as well as an adherence to standards-of-care across Japan. Further assessment of the causes of variation and non-adherence can help identify areas where improvements are needed in patient care.
Guideline Adherence ; Humans ; Insurance ; Japan* ; Methods ; Patient Care ; Platinum ; Proctoscopes ; Qi ; Standard of Care ; Uterine Cervical Neoplasms*

Fecal microbiota transplantation (FMT) has been reported as a safe and effective therapy in patients with refractory and recurrent Clostridium difficile infection (CDI). FMT has also been reported as a promising therapy in patients with ulcerative colitis (UC). Both, CDI and UC, are believed to be caused by dysbiosis, such as altered compositions or decreased diversity of the intestinal microbiota. This report describes a patient with UC in remission with a second recurrent episode of CDI, who was treated with FMT. A single FMT performed via colonoscopy completely resolved the patient's diarrhea and eradicated C. difficile bacteriologically without any severe complications. Molecular biological analysis of the patient's fecal microbiota showed that FMT could dramatically change the altered composition of intestinal microbiota and restore its diversity. Despite the restoration of the intestinal microbiota, FMT could not prevent a relapse of UC in this patient. However, it improved the intestinal symptoms of CDI and could prevent further recurrences of CDI.
Clostridium difficile ; Clostridium ; Colitis, Ulcerative ; Colonoscopy ; Diarrhea ; Dysbiosis ; Fecal Microbiota Transplantation ; Gastrointestinal Microbiome ; Humans ; Microbiota ; Recurrence ; Ulcer

A 60-year-old man with type 2 diabetes mellitus and severe obesity (height 170 cm, weight 160 kg, BMI 55) was admitted to our hospital because of acute inferior wall myocardial infarction due to acute thromboembolism of the right coronary artery (RCA). Because of three-vessel coronary diseases, we planned coronary artery bypass grafting after the medical therapy. The patient was intubated, then suffered congestive heart failure and pneumonia, and had a tracheotomy because of obesity hypoventilation syndrome. When his general condition improved after 14 months of medical therapy, we performed the operation. At that time, his weight had decreased to 107.5 kg, and BMI decreased to 37.2. We decided that tracheotomy was necessary to avoid respiratory complications. We chose a thoracoabdominal spiral incision for 2 reasons. Firstly we needed to avoid wound contamination by the tracheotomy stoma. Secondly we decided that the left internal thoracic artery (LITA) and the right gastroepiploic artery (RGEA) were sufficient for bypass grafts to the left anterior descending artery (LAD), the diagonal branches (D1), the posterolateral artery (PL) and the posterior descending artery (PD). Before the operation, epidural anesthesia was performed for postoperative analgesia to prevent respiratory dysfunction. In the right semi-lateral position at 30°, a 4th intercostal space thoracotomy was performed, and the LITA was harvested. The skin incision was extended to the midline of the abdomen and the RGEA was harvested. The end of the LITA was anastomosed with the free RGEA as I composite and the composite was anastomosed to the LAD, the D1, the 14 PL and the 4 PL without cardiopulmonary bypass. Without any perioperative blood transfusion, the patient was discharged with no perioperative complication, including mediastinitis. With this incision, we achieved secure prevention of wound contamination by the tracheotomy stoma, harvesting of a sufficient length of the LITA and RGEA and good visualization of the anastomotic sites with less cardiac displacement than median sternotomy.

A 58-year-old man underwent aortic root replacement for annuloaortic ectasia (AAE) and aortic regurgitation (AR). The patient was readmitted because of chest discomfort 3 months after the first operation. Computed tomography showed a pseudoaneurysm of the ascending aorta. Re-aortic root replacement was done on an emergency basis. However, 16 days after the second operation, a pseudoaneurysm was revealed by computed tomography. The third operation was successfully performed using a rif ampicin-bonded gelatin-sealed Dacron graft (GELSEAL^®; Sulzer Vascutek, Glasgow, UK). The postoperative course was uneventful.

We report a 66-year-old woman with circulatory collapse due to acute pulmonary thromboembolism, in whom a left nephrectomy for a renal tumor was scheduled. Following preoperative renal angiography. The patient suffered sudden shock resulting from pulmonary thromboembolism (PTE) following release of compression of the puncture site. The patient was transported to the ICU, and percutaneous cardiopulmonary support (PCPS) was instituted immediately for resuscitation. Hemodynamics were stabilized by PCPS and percutaneous thrombectomy was attempted. However, perforation by a catheter inverted to the extracardiac space occurred, which neccesitated emergency surgical hemostasis. PCPS was converted to cardiopulmonary bypass (CPB). The injured right ventricle and right atrial walls were repaired, and pulmonary thrombectomy was performed via the pulmonary trunk. CPB was easily terminated and her postoperative course was uneventful with anticoagulant therapy. Left nephrectomy was performed two months later. PTE recurred due to the interruption of anticoagulation for surgical treatment of a renal tumor. Percutaneous pulmonary thrombectomy and thrombolysis therapy were effective and a Greenfield filter was inserted into the inferior vena cava to prevent recurrence.