Academic Journal
Protocol for a Multi-Center Confirmatory Trial to Evaluate the Differential Diagnostic Performance of Contrast-Enhanced Ultrasonography Using Perflubutane in Patients with a Pancreatic Mass: A Multicenter Prospective Study
| Title: | Protocol for a Multi-Center Confirmatory Trial to Evaluate the Differential Diagnostic Performance of Contrast-Enhanced Ultrasonography Using Perflubutane in Patients with a Pancreatic Mass: A Multicenter Prospective Study |
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| Authors: | Yasunobu Yamashita, Toshio Shimokawa, Reiko Ashida, Yoshiki Hirooka, Takuji Iwashita, Hironari Kato, Toshifumi Kin, Atsushi Masamune, Haruo Miwa, Eizaburo Ohno, Hideyuki Shiomi, Atsushi Sofuni, Mamoru Takenaka, Masayuki Kitano |
| Source: | Diagnostics, Vol 14, Iss 2, p 130 (2024) |
| Publisher Information: | MDPI AG, 2024. |
| Publication Year: | 2024 |
| Collection: | LCC:Medicine (General) |
| Subject Terms: | contrast-enhanced transabdominal ultrasonography, contrast-enhanced endoscopic ultrasonography, pancreatic cancer, perflubutane, Medicine (General), R5-920 |
| More Details: | For pancreatic masses, an evaluation of their vascularity using contrast-enhanced ultrasonography can help improve their characterization. This study was designed to evaluate the utility and safety of contrast-enhanced transabdominal ultrasonography (CE-TUS) and endoscopic ultrasonography (CE-EUS) in the diagnosis of pancreatic masses including solid or cystic masses. This multi-center comparative open-label superiority study is designed to compare Plain (P)-TUS/EUS alone with P-TUS/P-EUS plus CE-TUS/CE-EUS. Three hundred and one patients with a total of 232 solid pancreatic masses and 69 cystic masses were prospectively enrolled. The primary endpoints are to compare the diagnostic accuracy between P-TUS/P-EUS alone and P-TUS/P-EUS plus CE-TUS/CE-EUS for both the TUS and EUS of solid pancreatic masses, and to compare the diagnostic accuracy between P-EUS alone and P-EUS plus CE-EUS in cystic pancreatic masses. The secondary endpoints are to compare the diagnostic sensitivity and specificity of P-TUS/P-EUS alone and P-TUS/P-EUS plus CE-TUS/CE-EUS for pancreatic solid/cystic masses, and the accuracy of P-TUS alone and P-TUS plus CE-TUS for pancreatic cystic masses. Other secondary endpoints included comparing the diagnostic sensitivity, specificity, and accuracy of CE-TUS, CE-EUS and CE-computed tomography (CT) for solid/cystic pancreatic masses. The safety, degree of effective enhancement, and diagnostic confidence obtained with CE-TUS/CE-EUS will also be assessed. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 14020130 2075-4418 |
| Relation: | https://www.mdpi.com/2075-4418/14/2/130; https://doaj.org/toc/2075-4418 |
| DOI: | 10.3390/diagnostics14020130 |
| Access URL: | https://doaj.org/article/8057534cdb684c699963636dfe8a9709 |
| Accession Number: | edsdoj.8057534cdb684c699963636dfe8a9709 |
| Database: | Directory of Open Access Journals |
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| ISSN: | 14020130 20754418 |
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| DOI: | 10.3390/diagnostics14020130 |
| Published in: | Diagnostics |
| Language: | English |