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Supportive Care in Cancer

, Volume 27, Issue 3, pp 1081–1088 | Cite as

Evaluation of stent placement for vena cava syndrome: phase II trial and phase III randomized controlled trial

  • Yoshito Takeuchi
  • Yasuaki Arai
  • Miyuki Sone
  • Shunsuke SugawaraEmail author
  • Takeshi Aramaki
  • Rui Sato
  • Kimihiko Kichikawa
  • Toshihiro Tanaka
  • Hiroyuki Morishita
  • Takaaki Ito
  • Koichiro Yamakado
  • Yasutaka Baba
  • Takeshi Kobayashi
Original Article
  • 136 Downloads

Abstract

Purpose

Vena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients’ quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS.

Methods

In the phase II trial, 28 eligible patients were treated with stent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients’ symptom scores during 14 days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n = 16) and control groups (n = 16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28 days after enrollment.

Results

In the phase II trial, the median patients’ symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups.

Conclusions

Stent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS.

Trial registration: JIVROSG-0402, JIVROSG-0807

Keywords

Vena cava syndrome Stent placement Symptom palliation Randomized controlled trial Quality of life 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in this study which involved human participants were in accordance with the ethical standards of the institutional national research committee and with the 1964 Helsinki declaration and its later amendments are comparable ethical standards.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Yoshito Takeuchi
    • 1
    • 2
  • Yasuaki Arai
    • 1
  • Miyuki Sone
    • 1
  • Shunsuke Sugawara
    • 1
    Email author
  • Takeshi Aramaki
    • 3
  • Rui Sato
    • 3
  • Kimihiko Kichikawa
    • 4
  • Toshihiro Tanaka
    • 4
  • Hiroyuki Morishita
    • 5
  • Takaaki Ito
    • 5
  • Koichiro Yamakado
    • 6
    • 7
  • Yasutaka Baba
    • 8
    • 9
  • Takeshi Kobayashi
    • 10
  1. 1.Department of Diagnostic RadiologyNational Cancer Center HospitalChuo-kuJapan
  2. 2.Department of RadiologyFukuchiyama City HospitalFukuchiyamaJapan
  3. 3.Division of Interventional RadiologyShizuoka Cancer CenterShizuokaJapan
  4. 4.Department RadiologyNara Medical UniversityKashiharaJapan
  5. 5.Department of Diagnostic RadiologyJapan Red Cross Kyoto Daiichi HospitalKyotoJapan
  6. 6.Department of RadiologyMie University School of MedicineTsuJapan
  7. 7.Department of RadiologyHyogo College of MedicineHyogoJapan
  8. 8.Department of RadiologyKagoshima University HospitalKagoshimaJapan
  9. 9.Department of Diagnostic RadiologyHiroshima University HospitalHiroshimaJapan
  10. 10.Department of Diagnostic and Interventional RadiologyIshikawa Prefectural Central HospitalKanazawaJapan

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