PMID- 20884240
OWN - NLM
STAT- MEDLINE
DCOM- 20110211
LR  - 20101029
IS  - 1535-7732 (Electronic)
IS  - 1051-0443 (Linking)
VI  - 21
IP  - 11
DP  - 2010 Nov
TI  - Phase I/II multiinstitutional study of uterine artery embolization with gelatin 
      sponge for symptomatic uterine leiomyomata: Japan Interventional Radiology in 
      Oncology Study Group study.
PG  - 1665-71
LID - 10.1016/j.jvir.2010.07.017 [doi]
AB  - PURPOSE: This multicenter prospective study was conducted to evaluate the safety 
      and the efficacy of uterine artery embolization (UAE) with gelatin sponge for 
      symptomatic leiomyomas. MATERIALS AND METHODS: Patients with symptomatic uterine 
      leiomyomas were enrolled and treated with UAE. In phase I, nine patients were 
      evaluated for safety. In phase II, 24 patients were accrued, and an 
      intent-to-treat analysis was performed on all 33 patients. The primary endpoint 
      was safety. Secondary endpoints included technical success, hospital stay, change 
      in symptoms, leiomyoma volume on magnetic resonance (MR) imaging, and incidence 
      of treatment failure. RESULTS: UAE procedures were performed for all 33 patients. 
      Two patients were lost to follow-up at 3 and 12 months. The median follow-up 
      period was 33.4 months. Minor adverse events (AEs) occurred in 10 patients (33%); 
      major AEs of permanent amenorrhea and leiomyoma expulsion occurred in two (6%). 
      The most common AE was transient amenorrhea. Technical success was achieved in 
      all patients. The median hospital stay was 5 days. At 12 months after UAE, 
      menorrhagia had improved in 90% of patients, pelvic pain in 78%, and bulk-related 
      symptoms in 97%. The mean reduction in leiomyoma volume on MR imaging at 12 
      months was 61%. Treatment failure occurred in one patient, who underwent 
      hysterectomy for recurrent menorrhagia at 21 months. CONCLUSIONS: UAE with 
      gelatin sponge is safe, with efficacy comparable to other embolic agents based on 
      published data. Gelatin sponge should be an option for UAE, but a prospective 
      comparison versus other standard UAE embolic agents may be warranted.
CI  - Copyright (c) 2010 SIR. Published by Elsevier Inc. All rights reserved.
FAU - Sone, Miyuki
AU  - Sone M
AD  - Department of Radiology, Iwate Medical University, Uchimaru, Morioka, Japan. 
      msone@athena.ocn.ne.jp
FAU - Arai, Yasuaki
AU  - Arai Y
FAU - Shimizu, Tadashi
AU  - Shimizu T
FAU - Takeuchi, Yoshito
AU  - Takeuchi Y
FAU - Higashihara, Hideyuki
AU  - Higashihara H
FAU - Ohgi, Shirei
AU  - Ohgi S
FAU - Ishiguchi, Tsuneo
AU  - Ishiguchi T
FAU - Saitoh, Hiroya
AU  - Saitoh H
FAU - Sakaguchi, Hiroshi
AU  - Sakaguchi H
FAU - Tanaka, Toshihiro
AU  - Tanaka T
FAU - Shioyama, Yasukazu
AU  - Shioyama Y
FAU - Tanigawa, Noboru
AU  - Tanigawa N
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100929
PL  - United States
TA  - J Vasc Interv Radiol
JT  - Journal of vascular and interventional radiology : JVIR
JID - 9203369
SB  - IM
MH  - Adult
MH  - Female
MH  - *Gelatin Sponge, Absorbable
MH  - Humans
MH  - Japan
MH  - Leiomyoma/pathology/*therapy
MH  - Length of Stay
MH  - Magnetic Resonance Imaging
MH  - Middle Aged
MH  - Prospective Studies
MH  - Time Factors
MH  - Treatment Outcome
MH  - *Uterine Artery Embolization/adverse effects
MH  - Uterine Neoplasms/pathology/*therapy
EDAT- 2010/10/05 06:00
MHDA- 2011/02/12 06:00
CRDT- 2010/10/02 06:00
PHST- 2009/03/26 00:00 [received]
PHST- 2010/06/30 00:00 [revised]
PHST- 2010/07/15 00:00 [accepted]
PHST- 2010/10/02 06:00 [entrez]
PHST- 2010/10/05 06:00 [pubmed]
PHST- 2011/02/12 06:00 [medline]
AID - S1051-0443(10)00780-3 [pii]
AID - 10.1016/j.jvir.2010.07.017 [doi]
PST - ppublish
SO  - J Vasc Interv Radiol. 2010 Nov;21(11):1665-71. doi: 10.1016/j.jvir.2010.07.017. 
      Epub 2010 Sep 29.