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

Mayu Uka, Jun Sakurai, Yusuke Matsui, Toshihiro Iguchi, Koji Tomita, Noriyuki Umakoshi, Kazuaki Munetomo, Toshiharu Mitsuhashi, Hideo Gobara, Takao Hiraki

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)746-751
Number of pages6
JournalNagoya journal of medical science
Volume84
Issue number4
DOIs
Publication statusPublished - 2022

Keywords

  • Intervention
  • Sclerotherapy
  • Venous malformation

ASJC Scopus subject areas

  • Medicine(all)

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this