Clinical evidence on whether acute cholangitis accelerates early stent failure via rapid bacterial adhesion and biofilm formation remains limited. We assessed the influence of pre-endoscopic retrograde cholangiopancreatography (ERCP) cholangitis on time to recurrent biliary obstruction (TRBO) and early post-ERCP infection in patients with distal malignant biliary obstruction (DMBO). We retrospectively reviewed consecutive patients with DMBO who underwent their first ERCP-guided stenting at five Japanese centers (January 2020–August 2024). Patients were classified by pre-ERCP cholangitis status and matched at a 2:1 ratio of noncholangitis to cholangitis using propensity scores (PSM). The primary outcome was TRBO; secondary outcomes were post-ERCP infection, clinical success, and RBO rates. TRBO was analyzed using Kaplan–Meier, log-rank, and multivariable Cox analyses; sensitivity analyses yielded concordant results. Of 588 eligible patients, 508 had no cholangitis. PSM yielded 136 and 68 patients in well-balanced groups. The median TRBO was 140 vs. 114 d (p = 0.939). In the Cox models, nonpancreatic etiology lowered RBO risk (hazard ratio [HR]: 0.59, p = 0.04); plastic stents carried a higher risk than metal (HR: 4.71, p < 0.001), and pre-ERCP cholangitis was not associated with RBO (HR: 1.20, p = 0.46). Infections occurred in 9.6 and 4.4
Graft intolerance syndrome (GIS) is a well-recognized complication after kidney allograft failure, characterized by fever, graft pain, and systemic inflammation. Management options include continued immunosuppression, graft nephrectomy, and renal artery embolization, each associated with specific risks. We report a case of GIS successfully treated with percutaneous renal allograft artery embolization using carbon dioxide angiography in a patient with iodinated contrast allergy. A 66-year-old woman with autosomal dominant polycystic kidney disease underwent living-donor kidney transplantation and later developed chronic allograft dysfunction, eventually resuming hemodialysis. Following immunosuppression tapering, she presented with recurrent fever and pain over the renal allograft. Despite broad-spectrum antibiotic therapy, her symptoms persisted and imaging showed no abscess formation. Repeated blood cultures were negative. Allograft biopsy revealed extensive tissue necrosis with interstitial inflammation and vascular thrombosis. Multiple donor-specific anti-human leukocyte antigen antibodies with high mean fluorescence intensity were detected, suggesting ongoing alloimmune sensitization. Based on the clinical course and investigations, GIS was diagnosed. Given the high surgical risk and contrast allergy, percutaneous embolization of the renal allograft artery was performed using a combination of carbon dioxide angiography and CT guidance. Clinical symptoms improved promptly after the procedure, allowing discontinuation of calcineurin inhibitor therapy and steroid tapering, with no recurrence during follow-up. This case highlights carbon dioxide contrast angiography- and computed tomography-guided renal artery embolization as a safe and effective minimally invasive treatment option for GIS, particularly in patients unsuitable for iodinated contrast media or surgical nephrectomy.
Recently, we reported the real-world effectiveness of palbociclib plus endocrine therapy (ET) in HR+/HER2– advanced breast cancer (ABC) in Japan (NCT05399329). However, median overall survival (OS) was not reached because of limited follow-up (36 months). Here, we present follow-up data from this study, including real-world clinical outcomes and treatment patterns. The P-BRIDGE study was a multi-center, observational study evaluating the real-world effectiveness and treatment patterns of patients diagnosed with HR+/HER2– ABC who received palbociclib plus ET in first (1L) or second line (2L) in Japan. The primary endpoint was real-world progression-free survival (rwPFS); secondary endpoints included OS and chemotherapy-free survival (CFS). Of the 693 eligible patients, 426 and 267 patients received palbociclib with ET as 1L and 2L treatment, respectively. After a median follow-up of 48.1 months, the median rwPFS (95
Learning curves for robot-assisted rectal resection are mainly reported for the da Vinci platform. We evaluated the learning curve and short-term outcomes after introducing the hinotori™ Surgical Robot System as the first robotic platform for a surgeon with no prior console experience and a team with no prior robotic surgery experience. We retrospectively analyzed 60 consecutive robot-assisted rectal resections performed using the hinotori™ Surgical Robot System at a single center. The primary and secondary outcomes were the console time and robot roll-in–to–console start time, respectively. The case mix was adjusted using the Veenhof technical difficulty score and procedure type, and the change point was identified using risk-adjusted cumulative sum (RA-CUSUM) analysis. The RA-CUSUM curve peaked at case 27, defining the learning (cases 1–27) and stable (cases 28–60) phases. The median console time decreased from 198 min (interquartile range, 137–251) to 156 min (112–193) (p = 0.014) despite increased technical difficulty (median Veenhof score, 12 [9–16] vs. 17 [11–22]; p = 0.040). The median robot roll-in–to–console start time was 9 (8–12) and 9 (7–11) min in the learning and stable phases, respectively (p = 0.817). No surgery was converted to open surgery. In addition, postoperative and key pathological outcomes were comparable between phases. In this first robotic platform setting, our case-mix–adjusted analysis suggested that the console time stabilized after 27 cases. The robot roll-in–to–console start time remained stable throughout, suggesting early standardization of the pre-console workflow.
Background Biologic therapies are pivotal in managing severe asthma. Despite their efficacy, some patients discontinue biologics, with varying outcomes. Predictors of successful versus unsuccessful discontinuation remain poorly defined. This study aimed to identify clinical factors associated with post-discontinuation outcomes in a real-world practice. Methods This retrospective cohort included adults with severe asthma who had received biologics for at least 12 months and subsequently discontinued therapy for a minimum of three consecutive months. We assessed the effects of baseline blood eosinophilia (≥300 cells/μL), residual sputum symptoms during biologic therapy, treatment responsiveness, biologic class, and discontinuation reasons on post-discontinuation asthma exacerbation rates using multivariable Cox models. Results A total of 118 patients were analyzed. The Kaplan–Meier analysis estimated a 65 % exacerbation-free probability at 12 months after discontinuation. Factors associated with successful discontinuation included a robust clinical response and absence of exacerbations before cessation. Conversely, baseline eosinophilia, residual sputum symptoms during biologics, and discontinuation due to inadequate therapeutic response or financial burden were associated with post-discontinuation exacerbations. In class-stratified restricted models, persistent sputum remained significantly associated with post-discontinuation exacerbations after stopping anti-IL-5 therapies, while baseline eosinophilia was associated with post-discontinuation exacerbations after stopping anti-IgE or anti-IL-4Rα. Among patients with sputum symptoms or poor-response discontinuation, the overall frequency of exacerbations declined after discontinuation. Conclusions Baseline eosinophilia, persistent sputum during therapy, and discontinuation prompted by poor response or cost may serve as risk factors for post-discontinuation exacerbations; however, risk is phenotype- and class-dependent. Careful patient selection and monitoring are essential when considering the discontinuation of biologic treatment.
