2024-03-29T05:11:00Z
https://nagoya.repo.nii.ac.jp/oai
oai:nagoya.repo.nii.ac.jp:02004202
2023-04-28T06:33:44Z
499:508:509:1669094631719
A single-center, single-arm, prospective, open-label trial to evaluate the efficacy and safety of percutaneous sclerotherapy with polidocanol for painful venous malformations (SCIRO-2001): study protocol
Uka, Mayu
Sakurai, Jun
Matsui, Yusuke
Iguchi, Toshihiro
Tomita, Koji
Umakoshi, Noriyuki
Munetomo, Kazuaki
Mitsuhashi, Toshiharu
Gobara, Hideo
Hiraki, Takao
venous malformation
sclerotherapy
intervention
This single-center, single-arm, prospective open-label trial is being conducted to evaluate the short-term efficacy and safety of percutaneous sclerotherapy with polidocanol foam for painful venous malformations. This study will include patients who were clinically diagnosed with venous malformation by using ultrasound and/or magnetic resonance imaging, and whose pain persisted even after treatment with medications. Written informed consent for sclerotherapy will be obtained from all patients. The institutional review board approved this prospective study protocol. The primary endpoint is pain relief at three months after sclerotherapy. Local pain related to venous malformation will be evaluated using a numeric rating scale. Patient recruitment commenced in December of 2020. Enrolment of 13 patients is planned over a 3-year recruitment period. Herein, we describe the details of the clinical trial protocol.
departmental bulletin paper
Nagoya University Graduate School of Medicine, School of Medicine
2022-11
application/pdf
Nagoya Journal of Medical Science
4
84
746
751
0027-7622
2186-3326
https://nagoya.repo.nii.ac.jp/record/2004202/files/06_Uka.pdf
eng
https://www.med.nagoya-u.ac.jp/medlib/nagoya_j_med_sci/844.html
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