EpistaxisEPICOSTNCT05281952
Medico-economic Evaluation of Management Strategies for Severe Epistaxis
A study testing endoscopic ligation and Supra-selective embolization in people with Epistaxis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis
- What is being tested?
- endoscopic ligation and Supra-selective embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital
Toulouse
Guillaume DE BONNECAZE, MD
About this study
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.
Read the detailed 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
- Conditions
- Epistaxis
- Being tested
- endoscopic ligation, Supra-selective embolization
- Keywords
- Severe epistaxis, endoscopic ligation, Supra-selective embolization
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ligationProcedure or surgery
the surgical ligation of one or both sphenopalatine arteries by endoscopic way.
Supra-selective embolizationProcedure or surgery
occlusion of the terminal branches of the nasal external carotid artery.
| Study group | Role | What they receive |
|---|---|---|
| endoscopic ligation | Experimental | Not described Receives: Procedure: endoscopic ligation |
| Supra-selective embolization | Active comparator | Not described Receives: Procedure: Supra-selective embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
incremental cost-utility ratio
the cost-utility ratio integrating direct medical and non-medical costs
Measured: Month 18
Secondary outcomes (13)
number of recurrences
Measured: Month 18
time to first recurrence
Measured: Month 18
the number of complications
Measured: Month 18
nature of complications
Measured: Month 18
quality of life with EQ-5D-5L
Measured: Month 18
quality of life with SNOT 22
Measured: Month 18
the number of hospitalizations
Measured: Month 18
duration of hospitalizations
Measured: Month 18
the addiction with KATZ scale
Measured: Month 18
incremental cost-effectiveness ratio
the incremental cost-effectiveness ratio (cost/number of recurrences avoided) from the perspective of the community
Measured: Month 18
the description of the costs of care
only for non-randomized patients
Measured: Month 18
financial benefit (1 year)
the annual financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective
Measured: Month 12
financial benefit (5 year)
the 5-year financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomization in two groups: endoscopic ligation or supra-selective embolization and real-life study for a third group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume DE BONNECAZE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281952
- Sponsor's protocol ID
- RC31/19-0550
- Other IDs
- 2020-A02824-35
- Acronym
- EPICOST
- Status last verified
- Aug 2023
- First submitted
- 7 Mar 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of Management Strategies for Severe Epistaxis
- ClinicalTrials.gov ID
- NCT05281952
- Acronym / sponsor ID
- EPICOST / RC31/19-0550
- Conditions
- Epistaxis
- Keywords
- Severe epistaxis, endoscopic ligation, Supra-selective embolization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomization in two groups: endoscopic ligation or supra-selective embolization and real-life study for a third group
| Arm | Type | Receives |
|---|---|---|
| endoscopic ligation | Experimental | Procedure: endoscopic ligation |
| Supra-selective embolization | Active comparator | Procedure: Supra-selective embolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic ligationthe surgical ligation of one or both sphenopalatine arteries by endoscopic way. | Procedure or surgery | endoscopic ligation |
| Supra-selective embolizationocclusion of the terminal branches of the nasal external carotid artery. | Procedure or surgery | Supra-selective embolization |
Primary outcome
incremental cost-utility ratio
Time frame: Month 18
the cost-utility ratio integrating direct medical and non-medical costs
13 secondary outcomes
number of recurrences
Time frame: Month 18
time to first recurrence
Time frame: Month 18
the number of complications
Time frame: Month 18
nature of complications
Time frame: Month 18
quality of life with EQ-5D-5L
Time frame: Month 18
quality of life with SNOT 22
Time frame: Month 18
the number of hospitalizations
Time frame: Month 18
duration of hospitalizations
Time frame: Month 18
the addiction with KATZ scale
Time frame: Month 18
incremental cost-effectiveness ratio
Time frame: Month 18
the description of the costs of care
Time frame: Month 18
financial benefit (1 year)
Time frame: Month 12
financial benefit (5 year)
Time frame: Year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume DE BONNECAZE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic ligation and Supra-selective embolization in people with Epistaxis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume DE BONNECAZE, MD (0567771641 ext. +33, debonnecaze.g@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incremental cost-utility ratio (time frame: Month 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.