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Medico-economic Evaluation of Management Strategies for Severe Epistaxis (EPICOST)

T

Toulouse University Hospital

Status

Enrolling

Conditions

Epistaxis

Treatments

Procedure: Supra-selective embolization
Procedure: endoscopic ligation

Study type

Interventional

Funder types

Other

Identifiers

NCT05281952
RC31/19-0550
2020-A02824-35 (Other Identifier)

Details and patient eligibility

About

Current recommendations consider surgical ligation and supra-selective embolization as equivalent in terms of efficacy and there is no clear consensus to choose between one and the other technique. In the absence of medico-economic studies, these recommendations could not be based on any differences in efficiency between the two techniques. The management of patients with severe non-traumatic epistaxis remains controversial and varies according to the hospital and/or university centers. In practice, the use of one or the other technique depends on the habits of each reference center.

Full description

The hypothesis is that early ligation of the sphenopalatine arteries would reduce the costs of care for the community while improving the quality of life of patients compared to supra-elective embolization.

This medico-economic superiority could go through:

  • reduction in the number of recurrences
  • reduction in the length of hospital stays.
  • reduction in the cost of postoperative care.
  • reduction of iatrogenic complications
  • improvement of functional suites upon return home.
  • Tertiary prevention of dependency, particularly among the elderly

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient with severe epistaxis who failed treatment with double tamponade for more than 48 hours.
  • Patient over 18 years old
  • Affiliated patient or beneficiary of a social security scheme.
  • Patient accepting the principle of randomization
  • Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion criteria

  • Patient with epistaxis secondary to facial and/or surgical trauma.
  • Patient with epistaxis related to a malignant tumor cause
  • Patient with a history of ligation or embolization
  • Patient under legal protection and/or curatorship and/or guardianship.
  • Impossibility of giving the person informed information and ensuring the subject's compliance due to impaired physical and/or psychological health.
  • Patient participating in another research including an exclusion period still in progress
  • Pregnant or breastfeeding patient

For non randomized patient

  • Patient with a contraindication to general anesthesia: severe and/or decompensated cardiac/hepatic/renal insufficiency, ASA score 4
  • Severe hemostasis disorders that cannot benefit from correction.
  • History of transient and/or definitive stroke of the ischemic type
  • Atheromatous overload

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

endoscopic ligation
Experimental group
Treatment:
Procedure: endoscopic ligation
Supra-selective embolization
Active Comparator group
Treatment:
Procedure: Supra-selective embolization

Trial contacts and locations

1

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Central trial contact

Guillaume DE BONNECAZE, MD

Data sourced from clinicaltrials.gov

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