Cirsoid AneurysmNCT05341336
Outcome and Prognostic Factors of Surgical Management of Scalp AVMs.
A study testing total surgical excision in people with Cirsoid Aneurysm, run by Assiut University at 1 site in Egypt.
Trial summary
Scalp arteriovenous malformations (AVMs) are rarely encountered vascular scalp anomalies that represent 8% of all AVMs. Different terms are being used to describe the vascular anomalies of the scalp include cirsoid aneurysm, racemosum aneurysm, plexiform angioma, arteriovenous fistula and arteriovenous malformation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cirsoid Aneurysm
- What is being tested?
- total surgical excision
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with scalp AVMs confirmed by various imaging techniques. AVMs of the scalp will include: cirsoid aneurysm, serpentinum aneurysm, racemosum aneurysm, plexiform angioma, arteriovenous fistula, high flow shunts and arteriovenous malformations.
- Age group: any age group.
- Aetiology: congenital, traumatic, or any.
Who cannot join
- High risk patients or unfit for surgery.
- Patients refused surgery, or scheduled for endovascular intervention.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospitals
Asyut, 71515
Mohamed Abdel-Basset Ali Mahmoud Khallaf, Prof, 00201006071988, khallaf@aun.edu.eg
Farrag Mohammad Farrag Saad, M.D, 00201065652394, Farragmohammad@aun.edu.eg
About this study
Official title: Outcome and Prognostic Factors of Surgical Management of Scalp Arteriovenous Malformations
Scalp arteriovenous malformations (AVMs) are rarely encountered vascular scalp anomalies that represent 8% of all AVMs. Different terms are being used to describe the vascular anomalies of the scalp include cirsoid aneurysm, racemosum aneurysm, plexiform angioma, arteriovenous fistula and arteriovenous malformation. Derived from the Greek language, kirsos, the term cirsoid aneurysm is used to describe the AVM as it resembles varix. Case studies reported approximately 200 cases with increased prevalence during the last 15 years. The etiology of scalp AVMs remains controversial, it can be spontaneous or traumatic. They generally develop in the trauma background and in patients over 30-year-old while spontaneous scalp AVM may present at birth and remains asymptomatic until adulthood.
Read the detailed description
Patients with scalp AVMs are usually presented with scalp swelling, and cosmetic concerns along with other presentations including headache, pain, tinnitus, audible bruits, palpable thrills, and hemorrhage. Neuro-radiological diagnosis is the cornerstone for the surgical procedure to be performed, and cranial angiography is of great significance for diagnosis and treatment selection. MRA is also of significance for establishing a diagnosis as scalp AVMs are confused with hemangioma and cavernomas. Treatment of the cirsoid aneurysm is difficult due to the abnormal fistulous communications between the feeding arteries and veins and high shunt flow. Management protocols for scalp AVMs include various options including surgical excision, endovascular embolization, ligation, and intralesional injections. Operative blood loss, postoperative cosmetic complications are significant concerns when treating scalp AVMs, thus various methods are used pre and postoperatively in order to control these concerns. A thorough analysis of scalp AVMs regarding anatomy, feeder vessels, size, and other different variables is required for a better understanding of the problem in order to improve the outcomes.
- Conditions
- Cirsoid Aneurysm
- Being tested
- total surgical excision
- Medical subject headings
- Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total surgical excisionProcedure or surgery
patients will be operated under general anesthesia. Pressure is applied along the incision line while staying away from the palpable margin of the AVM lesion and used Raney clips to control bleeding.
Once the skin flap was raised, the lesion could be seen through the galea. The galea around the lesion is incised, and the lesion will be separated from the underlying skin using a combination of bipolar diathermy and sharp dissection.
The nidus is often located in galeal aponeurosis. Dilated arteries and veins extended into subcutaneous tissue, which was separated with special care to prevent accidental nidus rupture and avoid excessive cauterization to prevent postoperative scalp necrosis.
Ligation is applied on feeder arteries, then applied to veins with total excision of the lesion.
After excision of the lesion, the skin flap was replaced with interrupted stitches.
The wound was allowed to heal primarily along with intravenous administration of antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Surgical excision | Experimental | complete surgical excision of the scalp AVMs after identifying feeding arteries, vein and high flew shunts to perform a complete devascularization of the AVM. Receives: Procedure: total surgical excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion of the feeding arteries and veins confirmation by imaging techniques
identifying the occluded arteries and vein of the excised AVM through the use of diagnostic radiology including CT angiography and conventional angiography to evaluate the results of a well planned surgical excision of scalp AVM.
This will be monitored for a period of 6 months post operative.
Measured: This will be monitored for a period of 6 months post-operative.
Cosmetic outcome according to the modified Hollandar scale
Following up the cosmetic outcome according to the modified Hollandar scale to achieve better prognosis and higher patient satisfaction.
The modified Hollandar scale: 0 score represents the best score, and an overall score of 6 points represents the worst outcome.
the use of the modified Hollander scale would be used for post-operative evaluation and a period of 6 month-follow-up.
Measured: This will be monitored for a period of 6 months post-operative.
Secondary outcomes (5)
Detect prognostic factors that affect the outcomes: etiology
By identifying the important factors affecting the outcome including:
etiology: congenital, traumatic or idiopathic. Studying how etiology can affect the outcome of surgical excision of scalp AVMs.
Measured: This will be monitored for a period of 6 months post-operative.
Detect prognostic factors that affect the outcomes: age
By identifying the important factors affecting the outcome including:
age Studying how age variation can affect the outcome of surgical excision of scalp AVMs and compare different age groups to prognosis.
Measured: This will be monitored for a period of 6 months post-operative.
Detect prognostic factors that affect the outcomes: site and size
By identifying the important factors affecting the outcome including:
site and size: the site and size of the scalp AVM and how the site affects the prognosis post-operative.
Measured: This will be monitored for a period of 6 months post-operative.
Detect prognostic factors that affect the outcomes: Primary arterial supply of the AVM, number of feeders
By identifying the important factors affecting the outcome including:
Primary arterial supply of the AVM, number of feeders: through the use of imaging techniques, determine the primary feeding arteries and their numbers and hw it will affect the prognosis and recurrence rate.
Studying the distribution of the AVMs and their primary arterial supply and the number of feeding arteries and how this can affect the outcome of surgical excision of scalp AVMs.
based on the anatomy of arterial supply.
Measured: This will be monitored for a period of 6 months post-operative.
Detect prognostic factors that affect the outcomes: clinical symptoms
By identifying the important factors affecting the outcome including:
clinical symptoms: how pre-operative symptoms could be indicative for prognosis compared to post-operative symptoms in case of any residuals.
Studying various symptoms compared with post-operative residuals, if any, and how they can affect the outcome of surgical excision of scalp AVMs.
Measured: This will be monitored for a period of 6 months post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cirsoid AneurysmStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonios Bakheet Henis Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341336
- Sponsor's protocol ID
- OPFSMSAM
- Status last verified
- Jan 2023
- First submitted
- 3 Dec 2021
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurkanlar D, Gonul M, Solmaz I, Gonul E. Cirsoid aneurysms of the scalp. Neurosurg Rev. 2006 Jul;29(3):208-12. doi: 10.1007/s10143-006-0023-y. Epub 2006 Apr 6.
PubMed 16598510Komiyama M, Nishikawa M, Kitano S, Sakamoto H, Imai K, Tsujiguchi K, Mizuno T. Non-traumatic arteriovenous fistulas of the scalp treated by a combination of embolization and surgical removal. Neurol Med Chir (Tokyo). 1996 Mar;36(3):162-5. doi: 10.2176/nmc.36.162.
PubMed 8869152Heilman CB, Kwan ES, Klucznik RP, Cohen AR. Elimination of a cirsoid aneurysm of the scalp by direct percutaneous embolization with thrombogenic coils. Case report. J Neurosurg. 1990 Aug;73(2):296-300. doi: 10.3171/jns.1990.73.2.0296.
PubMed 2366088Albuquerque Sousa LH, Maranha Gatto LA, Demartini Junior Z, Koppe GL. Scalp Cirsoid Aneurysm: An Updated Systematic Literature Review and an Illustrative Case Report. World Neurosurg. 2018 Nov;119:416-427. doi: 10.1016/j.wneu.2018.08.098. Epub 2018 Aug 24.
PubMed 30149169Sofela A, Osunronbi T, Hettige S. Scalp Cirsoid Aneurysms: Case Illustration and Systematic Review of Literature. Neurosurgery. 2020 Feb 1;86(2):E98-E107. doi: 10.1093/neuros/nyz303.
PubMed 31384940Furtado SV, Srinivasa R, Vala K, Mohan D. Contemporary management of scalp cirsoid aneurysm: A dual-trained neurosurgeon's perspective. Clin Neurol Neurosurg. 2021 Feb;201:106437. doi: 10.1016/j.clineuro.2020.106437. Epub 2020 Dec 15.
PubMed 33373833Li F, Zhu S, Liu Y, Chen Y, Chi L, Chen G, Zhang J, Qu F. Traumatic arteriovenous fistula of the superficial temporal artery. J Clin Neurosci. 2007 Jun;14(6):595-600. doi: 10.1016/j.jocn.2006.04.011. Epub 2007 Mar 26.
PubMed 17379525Mohamed WN, Abdullah NN, Muda AS. Scalp arteriovenous malformation : a case report. Malays J Med Sci. 2008 Jul;15(3):55-7.
PubMed 22570590Khodadad G. Arteriovenous malformations of the scalp. Ann Surg. 1973 Jan;177(1):79-85. doi: 10.1097/00000658-197301000-00015. No abstract available.
PubMed 4682507
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome and Prognostic Factors of Surgical Management of Scalp Arteriovenous Malformations
- ClinicalTrials.gov ID
- NCT05341336
- Acronym / sponsor ID
- OPFSMSAM
- Conditions
- Cirsoid Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Apr 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.
Scalp arteriovenous malformations (AVMs) are rarely encountered vascular scalp anomalies that represent 8% of all AVMs. Different terms are being used to describe the vascular anomalies of the scalp include cirsoid aneurysm, racemosum aneurysm, plexiform angioma, arteriovenous fistula and arteriovenous malformation. Derived from the Greek language, kirsos, the term cirsoid aneurysm is used to describe the AVM as it resembles varix. Case studies reported approximately 200 cases with increased prevalence during the last 15 years. The etiology of scalp AVMs remains controversial, it can be spontaneous or traumatic. They generally develop in the trauma background and in patients over 30-year-old while spontaneous scalp AVM may present at birth and remains asymptomatic until adulthood.
Detailed description
Patients with scalp AVMs are usually presented with scalp swelling, and cosmetic concerns along with other presentations including headache, pain, tinnitus, audible bruits, palpable thrills, and hemorrhage. Neuro-radiological diagnosis is the cornerstone for the surgical procedure to be performed, and cranial angiography is of great significance for diagnosis and treatment selection. MRA is also of significance for establishing a diagnosis as scalp AVMs are confused with hemangioma and cavernomas. Treatment of the cirsoid aneurysm is difficult due to the abnormal fistulous communications between the feeding arteries and veins and high shunt flow. Management protocols for scalp AVMs include various options including surgical excision, endovascular embolization, ligation, and intralesional injections. Operative blood loss, postoperative cosmetic complications are significant concerns when treating scalp AVMs, thus various methods are used pre and postoperatively in order to control these concerns. A thorough analysis of scalp AVMs regarding anatomy, feeder vessels, size, and other different variables is required for a better understanding of the problem in order to improve the outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical excision | Experimental | Procedure: total surgical excisioncomplete surgical excision of the scalp AVMs after identifying feeding arteries, vein and high flew shunts to perform a complete devascularization of the AVM. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with scalp AVMs confirmed by various imaging techniques. AVMs of the scalp will include: cirsoid aneurysm, serpentinum aneurysm, racemosum aneurysm, plexiform angioma, arteriovenous fistula, high flow shunts and arteriovenous malformations.
- Age group: any age group.
- Aetiology: congenital, traumatic, or any.
Key exclusion criteria (2 listed)
- High risk patients or unfit for surgery.
- Patients refused surgery, or scheduled for endovascular intervention.
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 |
|---|---|---|
| total surgical excisionpatients will be operated under general anesthesia. Pressure is applied along the incision line while staying away from the palpable margin of the AVM lesion and used Raney clips to control bleeding. Once the skin flap was raised, the lesion could be seen through the galea. The galea around the lesion is incised, and the lesion will be separated from the underlying skin using a combination of bipolar diathermy and sharp dissection. The nidus is often located in galeal aponeurosis. Dilated arteries and veins extended into subcutaneous tissue, which was separated with special care to prevent accidental nidus rupture and avoid excessive cauterization to prevent postoperative scalp necrosis. Ligation is applied on feeder arteries, then applied to veins with total excision of the lesion. After excision of the lesion, the skin flap was replaced with interrupted stitches. The wound was allowed to heal primarily along with intravenous administration of antibiotics. | Procedure or surgery | Surgical excision |
Primary outcome
Occlusion of the feeding arteries and veins confirmation by imaging techniques
Time frame: This will be monitored for a period of 6 months post-operative.
identifying the occluded arteries and vein of the excised AVM through the use of diagnostic radiology including CT angiography and conventional angiography to evaluate the results of a well planned surgical excision of scalp AVM. This will be monitored for a period of 6 months post operative.
Cosmetic outcome according to the modified Hollandar scale
Time frame: This will be monitored for a period of 6 months post-operative.
Following up the cosmetic outcome according to the modified Hollandar scale to achieve better prognosis and higher patient satisfaction. The modified Hollandar scale: 0 score represents the best score, and an overall score of 6 points represents the worst outcome. the use of the modified Hollander scale would be used for post-operative evaluation and a period of 6 month-follow-up.
5 secondary outcomes
Detect prognostic factors that affect the outcomes: etiology
Time frame: This will be monitored for a period of 6 months post-operative.
Detect prognostic factors that affect the outcomes: age
Time frame: This will be monitored for a period of 6 months post-operative.
Detect prognostic factors that affect the outcomes: site and size
Time frame: This will be monitored for a period of 6 months post-operative.
Detect prognostic factors that affect the outcomes: Primary arterial supply of the AVM, number of feeders
Time frame: This will be monitored for a period of 6 months post-operative.
Detect prognostic factors that affect the outcomes: clinical symptoms
Time frame: This will be monitored for a period of 6 months post-operative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 16598510Gurkanlar D, Gonul M, Solmaz I, Gonul E. Cirsoid aneurysms of the scalp. Neurosurg Rev. 2006 Jul;29(3):208-12. doi: 10.1007/s10143-006-0023-y. Epub 2006 Apr 6.
- Background: PubMed 8869152Komiyama M, Nishikawa M, Kitano S, Sakamoto H, Imai K, Tsujiguchi K, Mizuno T. Non-traumatic arteriovenous fistulas of the scalp treated by a combination of embolization and surgical removal. Neurol Med Chir (Tokyo). 1996 Mar;36(3):162-5. doi: 10.2176/nmc.36.162.
- Background: PubMed 2366088Heilman CB, Kwan ES, Klucznik RP, Cohen AR. Elimination of a cirsoid aneurysm of the scalp by direct percutaneous embolization with thrombogenic coils. Case report. J Neurosurg. 1990 Aug;73(2):296-300. doi: 10.3171/jns.1990.73.2.0296.
- Background: PubMed 30149169Albuquerque Sousa LH, Maranha Gatto LA, Demartini Junior Z, Koppe GL. Scalp Cirsoid Aneurysm: An Updated Systematic Literature Review and an Illustrative Case Report. World Neurosurg. 2018 Nov;119:416-427. doi: 10.1016/j.wneu.2018.08.098. Epub 2018 Aug 24.
- Background: PubMed 31384940Sofela A, Osunronbi T, Hettige S. Scalp Cirsoid Aneurysms: Case Illustration and Systematic Review of Literature. Neurosurgery. 2020 Feb 1;86(2):E98-E107. doi: 10.1093/neuros/nyz303.
- Background: PubMed 33373833Furtado SV, Srinivasa R, Vala K, Mohan D. Contemporary management of scalp cirsoid aneurysm: A dual-trained neurosurgeon's perspective. Clin Neurol Neurosurg. 2021 Feb;201:106437. doi: 10.1016/j.clineuro.2020.106437. Epub 2020 Dec 15.
- Background: PubMed 17379525Li F, Zhu S, Liu Y, Chen Y, Chi L, Chen G, Zhang J, Qu F. Traumatic arteriovenous fistula of the superficial temporal artery. J Clin Neurosci. 2007 Jun;14(6):595-600. doi: 10.1016/j.jocn.2006.04.011. Epub 2007 Mar 26.
- Background: PubMed 22570590Mohamed WN, Abdullah NN, Muda AS. Scalp arteriovenous malformation : a case report. Malays J Med Sci. 2008 Jul;15(3):55-7.
- Background: PubMed 4682507Khodadad G. Arteriovenous malformations of the scalp. Ann Surg. 1973 Jan;177(1):79-85. doi: 10.1097/00000658-197301000-00015. No abstract available.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total surgical excision in people with Cirsoid Aneurysm, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Feb 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdel-Basset Ali Mahmoud Khallaf, Prof (00201006071988, khallaf@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion of the feeding arteries and veins confirmation by imaging techniques (time frame: This will be monitored for a period of 6 months post-operative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05341336, which also lists 9 linked publications.
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 2 Feb 2023.