| A multicenter, prospective, open label, randomized, controlled phase IIIb study of SH U 508 a (Levovist) for Doppler signal enhancement in the portal vascular system. | |
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MedLine Citation:
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PMID: 9816618 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: Assessment of the accuracy of SH U 508 A (Levovist) enhanced Doppler sonography in the evaluation of blood flow abnormalities in the portal vascular system. METHOD: In an open label, controlled, prospective multicenter study, patients referred for Doppler sonography of the portal vascular system were randomized to receive SH U 508 A if indicated or to an observation group (ratio of 4:1). Patients who had diagnostically insufficient Doppler signals received SH U 508 A (2.5 g [200, 300 or 400 mg/ml]), followed by confirmatory dynamic CT. Corresponding patients in the observation group received alternative imaging procedure(s). RESULTS: Of 588 patients 265 patients received SH U 508 A. In 253 (95.5%) of these patients a diagnosis was possible following administration of SH U 508 A (Levovist). Diagnostic confidence improved from 35.3% to 89.7%. If compared with dynamic CT, SH U 508 A enhanced Doppler had a sensitivity of 80.5% and a specificity of 89.7%. Whereas diagnosis was not possible with SH U 508 A enhanced Doppler in only 12 patients, a diagnosis was not possible in 29 patients with dynamic CT. SH U 508 A enhanced Doppler in particular improved visualization of the portal vein (15.6%), TIPS (15.8%), superior mesenteric vein (16.1%), collateral circulation (20.7%) and inferior mesenteric vein (25%). SH U 508 A was very well tolerated; only eight patients experienced minor adverse events possibly related to SH U 508 A administration. CONCLUSION: SH U 508 A enhanced Doppler improved the diagnostic confidence and visualization of the portal vascular system compared to base line scans with insufficient Doppler signal and proved reliable compared to dynamic CT. |
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Authors:
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M Gebel; M Caselitz; P E Bowen-Davies; S Weber |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Ultraschall in der Medizin (Stuttgart, Germany : 1980) Volume: 19 ISSN: 0172-4614 ISO Abbreviation: Ultraschall Med Publication Date: 1998 Aug |
Date Detail:
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Created Date: 1999-02-03 Completed Date: 1999-02-03 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8303585 Medline TA: Ultraschall Med Country: GERMANY |
Other Details:
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Languages: eng Pagination: 148-56 Citation Subset: IM |
Affiliation:
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Medizinische Hochschule Hannover, Germany. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Blood Flow Velocity / physiology Contrast Media* / adverse effects Female Humans Hypertension, Portal / ultrasonography Liver Diseases / ultrasonography Liver Neoplasms / secondary, ultrasonography Male Middle Aged Polysaccharides / adverse effects, diagnostic use* Portal System / ultrasonography* Portasystemic Shunt, Transjugular Intrahepatic Sensitivity and Specificity Ultrasonography, Doppler, Color / instrumentation* |
| Chemical | |
Reg. No./Substance:
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0/Contrast Media; 0/Polysaccharides; 127279-08-7/SHU 508 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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