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
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
Affiliations
Yasunobu Yamashita
Second Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-0012, Japan
Toshio Shimokawa
Clinical Study Support Center, Wakayama Medical University Hospital, Wakayama 641-0012, Japan
Reiko Ashida
Second Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-0012, Japan
Yoshiki Hirooka
Department of Gastroenterology and Gastroenterological Oncology, Fujita Health University School of Medicine, Toyoake 470-1192, Japan
Takuji Iwashita
First Department of Internal Medicine, Gifu University Hospital, Gifu 501-1194, Japan
Hironari Kato
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Okayama 700-8558, Japan
Toshifumi Kin
Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo 006-8555, Japan
Atsushi Masamune
Division of Gastroenterology, Tohoku University Graduate School of Medicine, Toyoake 980-8574, Japan
Haruo Miwa
Gastroenterological Center, Yokohama City University Medical Center, Yokohama 232-0024, Japan
Eizaburo Ohno
Department of Gastroenterology and Hepatology, University Graduate School of Medicine, Nagoya 466-8550, Japan
Hideyuki Shiomi
Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University, Nishinomiya 663-8501, Japan
Atsushi Sofuni
Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo 160-0023, Japan
Mamoru Takenaka
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka 589-8511, Japan
Masayuki Kitano
Second Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-0012, Japan
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.
