Optimization of Endoscopic Ultrasound Characteristics in the Diagnosis of Malignant Intraductal Papillary Mucinous Neoplasm.

OBJECTIVES: Endoscopic ultrasound (EUS) is an excellent diagnostic tool that provides high-resolution images of pancreatic cystic lesions. However, its role in the diagnosis of malignant intraductal papillary mucinous neoplasm (IPMN) remains limited and unclear. We aimed to determine the usefulness of this modality for such diagnosis. METHODS: Overall, 246 patients who underwent EUS for IPMN after computed tomography (CT)/magnetic resonance imaging (MRI) from April 2018 to June 2021 were followed up until March 2022. We assessed the added value of performing EUS after CT or MRI for diagnosing malignant IPMN, using receiver operating characteristic curve analysis. Walls as thick as 2 mm were considered thickened in this study if they were highly uneven. RESULTS: EUS clearly enhanced accuracy in identifying enhancing nodules and thickened walls. The areas under the receiver operating characteristic curve and corresponding 95% confidence intervals were 0.655 (0.549-0.760) and 0.566 (0.478-0.654) upon CT/MRI but 0.853 (0.763-0.942) and 0.725 (0.634-0.817) when observed using EUS. The combination of nodule size, thickened wall, and main duct size yielded the highest area under the receiver operating characteristic curve (0.944 [0.915-0.973]). CONCLUSIONS: EUS more accurately detects malignant IPMN, as uneven wall thickening and certain nodules cannot be identified with CT/MRI.

How Much More Efficient Are Adaptive Platform Trials Than Multiple Stand-Alone Trials? A Comprehensive Simulation Study for Streamlining Drug Development During a Pandemic.

With the coronavirus disease 2019 (COVID-19) pandemic, there is growing interest in utilizing adaptive platform clinical trials (APTs), in which multiple drugs are compared with a single common control group, such as a placebo or standard-of-care group. APTs evaluate several drugs for one disease and accept additions or exclusions of drugs as the trials progress; however, little is known about the efficiency of APTs over multiple stand-alone trials. In this study, we simulated the total development period, total sample size, and statistical operating characteristics of APTs and multiple stand-alone trials in drug development settings for hospitalized patients with COVID-19. Simulation studies using selected scenarios reconfirmed several findings regarding the efficiency of APTs. The APTs without staggered addition of drugs showed a shorter total development period than stand-alone trials, but the difference rapidly diminished if patient's enrollment was accelerated during the trials owing to the spread of infection. APTs with staggered addition of drugs still have the possibility of reducing the total development period compared with multiple stand-alone trials in some cases. Our study demonstrated that APTs could improve efficiency relative to multiple stand-alone trials regarding the total development period and total sample size without undermining statistical validity; however, this improvement varies depending on the speed of patient enrollment, sample size, presence/absence of family-wise error rate adjustment, allocation ratio between drug and placebo groups, and interval of staggered addition of drugs. Given the complexity of planning and implementing APT, the decision to implement APT during a pandemic must be made carefully.

Imaging predictors of clinical outcomes after endovascular treatment in MRI-selected patients with acute basilar artery occlusion.

PURPOSE: We aimed to investigate the impact of baseline infarct area and collateral status (CS), which are imaging predictors of clinical outcome following stroke, after endovascular treatment (EVT) in MRI-selected patients with acute basilar artery occlusion (BAO). METHODS: Patients with acute BAO who underwent EVT within 24 h after stroke from December 2013 to February 2021 were included in this retrospective, multicenter, observational study. The baseline infarct area was evaluated by the posterior circulation of Acute Stroke Prognosis Early Computed Tomography Score (pc-ASPECTS) using diffuse-weighted imaging (DWI), and CS was assessed by measuring the computed tomography angiography of the basilar artery (BATMAN) score and the posterior circulation collateral score (PC-CS) using magnetic resonance angiography (MRA). A Good outcome was defined as a modified Rankin scale score ≤ 3 at 3 months. For each imaging predictor, a multivariate logistic regression analysis was performed to evaluate its impact on good outcomes. RESULTS: A total of 86 patients were analyzed, and 37 (43.0%) had a good outcome. The latter showed significantly higher pc-ASPECTS than those without good outcomes. In multivariate analyses, a pc-ASPECTS ≥ 7 was significantly associated with good outcomes (OR, 2.98 [95% CI, 1.10-8.13], P = 0.032), while PC-CS ≥ 4 (OR, 2.49 [95% CI, 0.92-6.74], P = 0.073) and BATMAN score ≥ 5 (OR, 1.51 [95% CI, 0.58-3.98], P = 0.401) were not. CONCLUSIONS: In MRI-selected patients with acute BAO, pc-ASPECTS on DWI was an independent predictor of clinical outcomes after EVT, while the MRA-based CS assessments were not.

Comparison of decompression, decompression plus fusion, and decompression plus stabilization: a long-term follow-up of a prospective, randomized study.

BACKGROUND CONTEXT: Lumbar canal stenosis due to degenerative lumbar spondylolisthesis is one of the most common indications for lumbar spinal surgery. However, from a long-term perspective, it is still unclear which of these procedures should be performed: decompression, decompression plus fusion, or decompression plus stabilization. PURPOSE: This study aimed to present the long-term results of a randomized controlled trial of surgery for degenerative spondylolisthesis. STUDY DESIGN/SETTING: This is a long-term follow-up of a previously reported randomized controlled trial. PATIENT SAMPLE: Patients aged ≤75 years with single L4/5 level lumbar canal stenosis caused by degenerative lumbar spondylolisthesis were enrolled at two hospitals from May 1, 2003, to April 30, 2012; the final follow-up was on May 20, 2021. OUTCOME MEASURES: The following data were collected: modified Japanese Orthopedic Association (JOA) score, visual analog scale (VAS) score for lower back pain, leg pain, and numbness, and scores from eight Short-Form 36 (SF-36) subscales preoperatively, 1 year postoperatively, 5 years postoperatively, and at the final follow-up. METHODS: Patients were randomized to undergo decompression alone, decompression plus fusion, or decompression plus stabilization. The primary outcome measure was the change in VAS for lower back pain with secondary outcomes including the modified JOA score, VAS for leg pain, VAS for leg numbness, eight SF-36 subscale scores, and occurrence of reoperation at the last follow-up. RESULTS: Among 85 patients who were randomized, 66 responded to the current survey. The mean follow-up period was 12.3 years. The VAS score for low back pain improvement was not significantly different between the decompression and fusion groups at the mean follow-up of 12.3 years. Of the 12 secondary outcomes, 8 showed no significant difference between decompression and fusion, 12 showed no significant difference between decompression and stabilization, and 10 showed no significant difference between fusion and stabilization. CONCLUSIONS: Although additional instrumentation surgery did not significantly improve low back pain at the mean follow-up of 12.3 years compared with decompression alone, fusion surgery provided clinically meaningful improvements in patient-reported vitality, social functioning, role limitations due to personal or emotional problems, and mental health compared with decompression alone. TRIAL REGISTRATION: UMIN000028114.

Increase in Cerebral Blood Flow After Catheter Ablation of Atrial Fibrillation.

BACKGROUND: Recent studies have found that atrial fibrillation (AF) is a risk factor for cognitive impairment. Brain hypoperfusion is hypothesized as an underlying mechanism of cognitive decline in AF patients. OBJECTIVES: This study sought to assess changes in cerebral blood flow (CBF) and brain volume after catheter ablation of AF. METHODS: Patients undergoing catheter ablation of AF were enrolled in this prospective study. AF patients being treated with pharmaceuticals alone served as a control group. Brain magnetic resonance imaging was performed before and 6 months after catheter ablation. CBF was assessed by 2-dimensional phase-contrast magnetic resonance angiography. Brain volume and bilateral hippocampal volume were measured using FreeSurfer software. RESULTS: Of the 57 study patients (age 64 ± 11 years; 45 men; paroxysmal AF: n = 22; nonparoxysmal AF: n = 35), 48 patients were freed from tachyarrhythmia recurrence beyond a 3-month blanking period. Changes in CBF and brain perfusion over 6 months were significantly greater in the study patients than control (CBF: 39.26 vs -34.86 mL; P = 0.01, ANCOVA; brain perfusion: 3.78 vs -3.02 mL/100 mL/min; P = 0.009, ANCOVA), while changes in total brain volume and bilateral hippocampal volume were similar between 2 groups (total brain volume: 2.57 vs -2.15 mL; P = 0.32, ANCOVA; bilateral hippocampal volume: 0.03 vs 0.04 mL; P = 0.8, ANCOVA). Nonparoxysmal AF at baseline was an independent predictor of an increase in CBF of >32.6 mL/min. CONCLUSIONS: Catheter ablation of AF has favorable effects on CBF, particularly in nonparoxysmal AF. Our results may partially explain the association between cognitive decline and AF.