Efficacy and Safety of Endoscopic Ultrasonography-Guided Ethanol Injections of Small Pancreatic Neuroendocrine Neoplasms: a prospective, multicenter study.

BACKGROUND AND STUDY AIMS: Endoscopic ultrasonography (EUS)-guided ethanol injection (EI) has recently been introduced as one of the management strategies for pancreatic neuroendocrine neoplasms (PNENs). However, its role as a surgical alternative is unclear. We evaluated the efficacy and safety of EUS-EI in treating small PNENs through a prospective multicentre study. PATIENTS AND METHODS: Patients with Grade 1 tumours of ≤15 mm confirmed by pathology were included. The primary endpoint assessed efficacy and safety, measuring complete ablation using computed tomography at 1 and 6 months, prevention of adverse events (AEs) within 1 month, severe pancreatic fistula at 1 month, and diabetes mellitus (DM) incidence/worsening at 6 months. The composite endpoint of EUS-EI was compared with that of historical results of a study based on surgical treatment. RESULTS: Twenty-five patients with PNENs, with a median tumour size of 10.1 mm, were treated using EUS-EI. Seventy-six percent of the patients achieved the composite primary endpoint (19/25) (95% confidence interval [CI]=54.9%-90.6%), a proportion significantly higher than that of surgical treatment (P=0.0083). Regarding efficacy, 88% (22/25) of the patients achieved complete ablation at 1 and 6 months (95% CI=68.8%-97.5%). Regarding safety, 96% (24/25) of the patients had no severe AEs within 1 month (95% CI=79.7%-99.9%). No patients had severe pancreatic fistulas at 1 month, and 84% (21/25) of the patients had no incidence or exacerbation, or both, of DM at 6 months (95% CI=63.9%-95.5%). CONCLUSION: EUS-EI is safe and could be a potent treatment option for patients with small PNENs.

Predictors of discontinuation of osteoporosis treatment: sub-analysis of the Japanese osteoporosis intervention trial-05 (JOINT-05).

INTRODUCTION: To identify predictors of discontinuing treatment with teriparatide (TPTD) and alendronate (ALN), data from a randomized, controlled trial (JOINT-05) involving postmenopausal Japanese women at high risk of fracture were re-analyzed. MATERIALS AND METHODS: Participants received sequential therapy with once-weekly TPTD for 72 weeks followed by ALN for 48 weeks (TPTD-ALN group) or monotherapy with ALN for 120 weeks (ALN group). Background data including comorbidities, fracture prevalence, cognitive function, quality of life, activities of daily living, bone metabolism parameters, and nutrient intake were collected. The endpoints were 3 types of discontinuations by the reason: a poor compliance, adverse events (AEs), or any reason including those unrelated to AEs or poor compliance. Odds ratios (ORs) of baseline predictors of discontinuation were evaluated by single or multiple regression analysis. RESULTS: A total of 234 (49.0%) patients in the TPTD-ALN group and 167 (34.2%) patients in the ALN group discontinued. In the TPTD-ALN group, a lower serum calcium level was a significant predictor of compliance-related discontinuation. Serum 25-hydroxyvitamin D levels were lower in patients with lower serum calcium levels than with higher serum calcium levels. In the ALN group, poor cognitive function was significantly associated with compliance-related discontinuation, and higher body mass index and alcohol intake were predictors of AE-related discontinuation. Predictors of discontinuation were drug-specific. Lower serum calcium levels and poor cognitive function were predictors of discontinuing once-weekly TPTD and ALN, respectively. CONCLUSION: When starting TPTD and ALN treatment, careful attention to patients with lower serum calcium levels and poor cognitive function, respectively, may be needed for better treatment continuity.

Characteristics Behaviors of Coagulation and Fibrinolysis Markers in Acquired Thrombotic Thrombocytopenic Purpura.

INTRODUCTIONS: Patients with acquired thrombotic thrombocytopenic purpura (TTP) show no severe abnormalities in coagulation or fibrinolysis. However, the exact extent of the abnormalities is unclear. MATERIALS AND METHODS: This study analyzed 138 patients with acquired TTP and 46 patients with septic disseminated intravascular coagulation (DIC) who were included in a Japanese registry. Complete blood cell counts and 8 coagulation or fibrinolysis parameters were compared between the 2 groups. RESULTS: Platelet counts in the acquired TTP group were significantly lower than those in the septic DIC group (P < .001). The international normalized ratio of prothrombin time and the activated partial thromboplastin time in the septic DIC group were significantly higher and longer, respectively, than those in the acquired TTP group (P < .01). The antithrombin (AT) values were significantly lower in the septic DIC group than in the acquired TTP group (P < .001), the latter of which were almost normal. Although both groups revealed elevations of fibrinogen degradation product (FDP) and D-dimer, these levels were significantly higher in the septic DIC group than in the acquired TTP group (P < .001). Of 138 patients with acquired TTP, 25 (18.1%) were diagnosed with septic DIC by the diagnostic criteria of the Japanese Ministry Health, Labour and Welfare, and 78 (56.5%) by those of the Japanese Association of Acute Medicine. Receiver operating characteristic curve analysis showed that acquired TTP could be diagnosed based on severe thrombocytopenia (<20 × 109/L), normal AT level (>87%), and mildly elevated FDP (<23 µg/mL). CONCLUSIONS: Our results indicate that 3 routine laboratory tests could differentiate between acquired TTP and septic DIC.