Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial

2021 ◽  
Author(s):  
Pauline M.C. Stassen ◽  
Pieter Jan F. de Jonge ◽  
Marco J. Bruno ◽  
Arjun D. Koch ◽  
Arvind J. Trindade ◽  
...  
Keyword(s):  
Multicenter Trial ◽  
Safety And Efficacy ◽  
Endoscopic Necrosectomy ◽  
Pancreas Necrosis ◽  
International Multicenter

International Multicenter Trial on Clinical Natural Orifice Surgery—NOTES IMTN Study: Preliminary Results of 362 Patients

2010 ◽  
Vol 17 (2) ◽  
pp. 142-158 ◽  
Author(s):  
Ricardo Zorron ◽  
Chinnusamy Palanivelu ◽  
Manoel Passos Galvão Neto ◽  
Almino Ramos ◽  
Gustavo Salinas ◽  
...  
Keyword(s):  
Multicenter Trial ◽  
Natural Orifice Surgery ◽  
Natural Orifice ◽  
Preliminary Results ◽  
International Multicenter

Fab Fragments in Treatment of Digoxin Ingestion

PEDIATRICS ◽  
1983 ◽  
Vol 71 (1) ◽  
pp. 137-137
Author(s):  
THOMAS W. SMITH
Keyword(s):  
Multicenter Trial ◽  
Clinical Safety ◽  
Digitalis Toxicity ◽  
Safety And Efficacy ◽  
Fab Fragments ◽  
Life Threatening ◽  
September Issue

To the Editor.— Accompanying the paper of Zucker et al in the September issue of Pediatrics1 is a listing of sources from which digoxin-specific Fab fragments are stated to be available. Unfortunately, this is no longer the case. All of the individuals and institutions listed have been part of a multicenter trial of clinical safety and efficacy of purified digoxin-specific Fab fragments in the treatment of advanced, life-threatening digitalis toxicity. At the present time, however, supplies of the material are extremely limited, and several of the centers listed have exhausted their supplies of digoxin-specific Fab fragments.

scholarly journals Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results

2015 ◽  
Vol 123 (4) ◽  
pp. 897-905 ◽  
Author(s):  
Daniel H. Sahlein ◽  
Mohammad Fouladvand ◽  
Tibor Becske ◽  
Isil Saatci ◽  
Cameron G. McDougall ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Internal Carotid ◽  
Prospective Trial ◽  
Maximum Diameter ◽  
Pipeline Embolization Device ◽  
Safety And Efficacy ◽  
History Of ◽  
International Multicenter ◽  
Supraclinoid Internal Carotid Artery

OBJECT Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED). METHODS The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria. RESULTS In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40%) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64%), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6%), the deficits only worsened. In 5 patients (5%), new deficits had developed at the 6-month follow-up, while in another 6 patients (6%), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure. CONCLUSIONS Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.

scholarly journals Analytical and clinical evaluation of an electrochemiluminescence immunoassay for the determination of CA 125

1998 ◽  
Vol 44 (12) ◽  
pp. 2530-2536 ◽  
Author(s):  
Huub E van Ingen ◽  
Daniel W Chan ◽  
Walter Hubl ◽  
Hayato Miyachi ◽  
Rafael Molina ◽  
...  
Keyword(s):  
Multicenter Trial ◽  
Ca 125 ◽  
Newly Diagnosed ◽  
Cutoff Value ◽  
Gynecological Diseases ◽  
Electrochemiluminescence Immunoassay ◽  
Benign Gynecological Diseases ◽  
International Multicenter ◽  
Apparently Healthy

Abstract The CA 125 II assay on the Elecsys® 2010 analyzer was evaluated in an international multicenter trial. Imprecision studies yielded within-run CVs of 0.8–3.3% and between-day CVs of 2.4–10.9%; CVs for total imprecision in the manufacturer’s laboratory were 2.4–7.8%. The linear range of the assay extended to at least 4500 kilounits/L (three decades). Interference from triglycerides (10.3 mmol/L), bilirubin (850 μmol/L), hemoglobin (1.1 mmol/L), anticoagulants (plasma), and several widely used drugs was undetectable. Method comparisons with five other CA 125 II assays showed good correlation but differences in standardization. A 95th percentile cutoff value of 35 kilounits/L was calculated from values measured in 593 apparently healthy (pre- and postmenopausal) women. In 95% of patients with benign gynecological diseases CA 125 was ≤190 kilounits/L; 63% of patients with newly diagnosed ovarian carcinoma had values >190 kilounits/L. A comparison of CA 125 values obtained with the Elecsys test and with other common CA 125 tests in monitored patients being treated for ovarian cancer showed identical patterns. In conclusion, the Elecsys CA 125 II assay is linear over a broad range, yields precise and accurate results, is free from interferences, and compares well with other assays.

scholarly journals Benchmarking the Extent and Speed of Reperfusion: First Pass TICI 2c-3 Is a Preferred Endovascular Reperfusion Endpoint

2021 ◽  
Vol 12 ◽  
Author(s):  
Albert J. Yoo ◽  
Jazba Soomro ◽  
Tommy Andersson ◽  
Jeffrey L. Saver ◽  
Marc Ribo ◽  
...  
Keyword(s):  
Functional Independence ◽  
Multicenter Trial ◽  
Two Dimensions ◽  
National Institutes Of Health ◽  
Clinical Trial Registration ◽  
Early Improvement ◽  
Attractive Candidate ◽  
First Pass ◽  
Definition Of ◽  
International Multicenter

Background and Purpose: End-of-procedure substantial reperfusion [modified Treatment in Cerebral Ischemia (mTICI) 2b-3], the leading endpoint for thrombectomy studies, has several limitations including a ceiling effect, with recent achieved rates of ~90%. We aimed to identify a more optimal definition of angiographic success along two dimensions: (1) the extent of tissue reperfusion, and (2) the speed of revascularization.Methods: Core-lab adjudicated TICI scores for the first three passes of EmboTrap and the final all-procedures result were analyzed in the ARISE II multicenter study. The clinical impact of extent of reperfusion and speed of reperfusion (first-pass vs. later-pass) were evaluated. Clinical outcomes included 90-day functional independence [modified Rankin Scale (mRS) 0–2], 90-day freedom-from-disability (mRS 0–1), and dramatic early improvement [24-h National Institutes of Health Stroke Scale (NIHSS) improvement ≥ 8 points].Results: Among 161 ARISE II subjects with ICA or MCA M1 occlusions, reperfusion results at procedure end showed substantial reperfusion in 149 (92.5%), excellent reperfusion in 121 (75.2%), and complete reperfusion in 79 (49.1%). Reperfusion rates on first pass were substantial in 81 (50.3%), excellent reperfusion in 62 (38.5%), and complete reperfusion in 44 (27.3%). First-pass excellent reperfusion (first-pass TICI 2c-3) had the greatest nominal predictive value for 90-day mRS 0–2 (sensitivity 58.5%, specificity 68.6%). There was a progressive worsening of outcomes with each additional pass required to achieve TICI 2c-3.Conclusions: First-pass excellent reperfusion (TICI 2c-3), reflecting rapid achievement of extensive reperfusion, is the technical revascularization endpoint that best predicted functional independence in this international multicenter trial and is an attractive candidate for a lead angiographic endpoint for future trials.Clinical Trial Registration:http://www.clinicaltrials.gov, identifier NCT02488915.

Abstract P490: Influence of Balloon Guide Catheter Use on Procedural & Clinical Outcomes in the Escape-NA1 Trial

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Johanna Ospel ◽  
Martha Marko ◽  
Nishita Singh ◽  
Petra Cimflova ◽  
Arnuv Mayank ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Study Drug ◽  
Multicenter Trial ◽  
First Line ◽  
Vessel Occlusion ◽  
Endovascular Thrombectomy ◽  
Guide Catheter ◽  
To Receive ◽  
International Multicenter ◽  
Retrievable Stent

Purpose: We assessed whether balloon guide catheter (BGC) use during endovascular thrombectomy (EVT) influences procedural and clinical outcomes in the ESCAPE-NA1 trial. Methods: ESCAPE-NA1 was an international multicenter trial that randomized large vessel occlusion stroke patients who underwent endovascular thrombectomy (EVT) to receive Nerinetide vs. placebo. Information on EVT techniques and devices was extracted from angiographic images and procedure report forms. Effect estimates of BGC use on angiographic and clinical outcomes were obtained with logistic regression with adjustment for age, ASPECTS, baseline NIHSS, occlusion site, alteplase and study drug treatment. Results: Detailed information on EVT devices and technique was available for 891/1105 (80.6%) patients. A BGC was used in 599/891 patients (67.2%). BGC use was most common with a retrievable stent use (with or without distal access catheter) as the first-line approach (in 252/266 cases [94.7%] vs. combined approach (both aspiration and SR): 288/414 [69.6%], vs. contact aspiration: 37/159 cases [23.3%]). Overall, eTICI 2b/3 rates with vs. without BGC did not differ significantly (525/598 [87.8%] vs. 260/292 [89.0%]), but eTICI 2c/3 rates were significantly higher when a BGC was used (304/598 [50.8%] vs. 126/292 [43.2%], adjusted OR 1.39 [95%CI 1.05 - 1.9]). Good outcomes (mRS 0-2) were not associated with BGC use (adjusted OR 1.07 [95%CI 0.78 - 1.48]). Conclusion: BGC use was associated with a greater proportion of near-complete reperfusion, while there was no significant association with clinical outcomes.

Sign in / Sign up

Export Citation Format

Share Document