Cerebral AneurysmMININCRUSPNCT02345395
Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms
A study testing Aneurysm Clipping in people with Cerebral Aneurysm and Aneurysm, Middle Cerebral Artery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The study is designed to evaluate the efficacy and safety of minimally invasive neurosurgical techniques for patients with incidental cerebral aneurysms of the anterior circulation in the Hospital das Clínicas of the University of São Paulo Medical School. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Aneurysm, Aneurysm, Middle Cerebral Artery, Aneurysm, Anterior Communicating Artery
- What is being tested?
- Aneurysm Clipping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2013to Dec 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the diagnosis of incidental unruptured cerebral aneurysms (4mm to 2cm)
Who cannot join
- Patients who do not have adequate family care during the immediate post-operative period (the patient's family must commit to stay with the patient in the first five days after hospital discharge)
- Patients who are unable to communicate by telephone
- People with cardiovascular disease, liver or kidney failure.
- Pregnant women or breastfeeding
- Patients with coagulation abnormalities
- Patients with High Surgical Risk evaluated by different risk scores (ASA, AHA, Goldman, Detsky)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas of University of São Paulo Medical School
São Paulo, São Paulo, 05403-000
Mauricio Mandel, MD, 55 11 996299224, mauricio.mandel@gmail.com
Ester M Tomazini, 2661-7152/8014, ester.t@hc.fm.usp.br
About this study
The study is designed to evaluate the efficacy and safety of minimally invasive neurosurgical techniques for patients with incidental cerebral aneurysms of the anterior circulation in the Hospital das Clínicas of the University of São Paulo Medical School.
Read the detailed description
Minimally Invasive Neurosurgery is a inexorable tendency and it is already a reality in many centers of the world. It is a broad and relative concept and there is few consistent medical data to validate its benefits. In this manner, this is the first clinical trial in Brazil questioning the safety of the of minimally invasive surgery to treat incidental cerebral aneurysms of the anterior circulation. For countries like Brazil, the indirect demonstration of reduction in hospital costs through lower hospital stays is a breakthrough to provide better health for the entire population.
Patients with the diagnosis of incidental brain aneurysms of the anterior circulation will be recruited from the spontaneous demand of the Hospital das Clínicas of University of São Paulo Medical School. The investigators expect to recruit 60 patients for the experimental group and 60 for the control group.
In the study group patients will be submitted to a minimally invasive approach (transpalpebral mini fronto-orbital craniotomy or modified minipterional craniotomy). All patients in this group will be submitted to surgery starting at 8 o'clock in the morning. After 6 hours of the end of surgery, all patients will have a control CT scan and if the result is adequate, they are going to be discharged from the ICU with no IV drugs. The hospital discharge will be in the next day. The control group are patients that will be submitted to a classical pterional craniotomy with hospital discharge occurring in 4-5 days.
All patients will be submitted to the standard care offered by the Hospital das Clinicas. All surgical and ambulatory data will be collected by the main investigators (Dr. Mauricio Mandel and Dr. Eberval Figueiredo). The adverse events will be promptly reported to the chair of the department and to the CAPPESQ (the ethics committee of the hospital).
Ambulatory data will be collected during the regular post operative medical appointments and a web based questionnaire. The post operative follow-up is unified in only one ambulatory center and day (thursdays mornings).
Statistical analysis will compare primary and secondary objectives of the two groups, as specified in the study protocol.
- Conditions
- Cerebral Aneurysm, Aneurysm, Middle Cerebral Artery, Aneurysm, Anterior Communicating Artery, Aneurysm, Posterior Communicating Artery, Aneurysm, Carotid Artery, Brain Aneurysm
- Being tested
- Aneurysm Clipping
- Keywords
- Brain Aneurysm, Pterional Craniotomy, MiniPterional Craniotomy, Transpalpebral Approach, Unruptured Brain Aneurysm
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aneurysm ClippingProcedure or surgery
All Patients will be submitted to a surgical intervention in order to clip their unruptured brain aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Transpalpebral Approach | Experimental | Aneurysm Clipping - Patients will be submitted to a Transpalpebral Approach to Unruptured Anterior Circulation Aneurysm and they will be discharged from the hospital on the next day. Receives: Procedure: Aneurysm Clipping |
| NanoPterional Approach | Experimental | Aneurysm Clipping - Patients will be submitted to a Modified MiniPterional Approach (Nanopterional) to Unruptured Anterior Circulation Aneurysm and they will be discharged from the hospital on the next day. Receives: Procedure: Aneurysm Clipping |
| Classical Pterional Craniotomy | Sham comparator | Aneurysm Clipping - Patients will be submitted to a Classical Pterional Approach to Unruptured Anterior Circulation Aneurysm and they will be discharged from the hospital 4-5 days after the procedure. Receives: Procedure: Aneurysm Clipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Aneurysm Clipping (no residual cerebral aneurysm)
All patients will be submitted to a post operative angiography to asses the presence of residual cerebral aneurysm after clipping.
Measured: 3 months after surgery
Secondary outcomes (5)
All Cause Mortality
Measured: 1 year
Neurological Outcome
All patients will be classified with the Glasgow Outcome Scale, Rankin Scale
Measured: 1 year
Cosmetic Outcome
Comparison of pre and post operative photos and asses of patients satisfaction
Measured: 1 year
Surgical Safety assessed by number and description of Surgical Complications (infection rate, postoperative epidural/ contusional hematomas, number of reoperations, need of blood transfusion)
Measured: 1 year
Early Hospital Discharge
Safety of early Discharge in the Experimental Groups (need of early hospital readmission? and its causes)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startSep 2013
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Eberval G Figueiredo, MD, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345395
- Sponsor's protocol ID
- TRANSPALPEBRAL USP
- Acronym
- MININCRUSP
- Status last verified
- Jan 2014
- First submitted
- 19 Jan 2015
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ohjimi H, Taniguchi Y, Tanahashi S, Era K, Fukushima T. Accessing the Orbital Roof via an Eyelid Incision: The Transpalpebral Approach. Skull Base Surg. 2000;10(4):211-6. doi: 10.1055/s-2000-9337.
PubMed 17171150Andaluz N, Romano A, Reddy LV, Zuccarello M. Eyelid approach to the anterior cranial base. J Neurosurg. 2008 Aug;109(2):341-6. doi: 10.3171/JNS/2008/109/8/0341.
PubMed 18671651Abdel Aziz KM, Bhatia S, Tantawy MH, Sekula R, Keller JT, Froelich S, Happ E. Minimally invasive transpalpebral "eyelid" approach to the anterior cranial base. Neurosurgery. 2011 Dec;69(2 Suppl Operative):ons195-206; discussion 206-7. doi: 10.1227/NEU.0b013e31821c3ea3.
PubMed 21499147Figueiredo EG, Deshmukh V, Nakaji P, Deshmukh P, Crusius MU, Crawford N, Spetzler RF, Preul MC. An anatomical evaluation of the mini-supraorbital approach and comparison with standard craniotomies. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS212-20; discussion ONS220. doi: 10.1227/01.NEU.0000223365.55701.F2.
PubMed 17041490Figueiredo EG, Deshmukh P, Nakaji P, Crusius MU, Crawford N, Spetzler RF, Preul MC. The minipterional craniotomy: technical description and anatomic assessment. Neurosurgery. 2007 Nov;61(5 Suppl 2):256-64; discussion 264-5. doi: 10.1227/01.neu.0000303978.11752.45.
PubMed 18091240
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms
- ClinicalTrials.gov ID
- NCT02345395
- Acronym / sponsor ID
- MININCRUSP / TRANSPALPEBRAL USP
- Conditions
- Cerebral Aneurysm, Aneurysm, Middle Cerebral Artery, Aneurysm, Anterior Communicating Artery, Aneurysm, Posterior Communicating Artery, Aneurysm, Carotid Artery, Brain Aneurysm
- Keywords
- Brain Aneurysm, Pterional Craniotomy, MiniPterional Craniotomy, Transpalpebral Approach, Unruptured Brain Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Jan 2015 (estimated)
- 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.
The study is designed to evaluate the efficacy and safety of minimally invasive neurosurgical techniques for patients with incidental cerebral aneurysms of the anterior circulation in the Hospital das Clínicas of the University of São Paulo Medical School.
Detailed description
Minimally Invasive Neurosurgery is a inexorable tendency and it is already a reality in many centers of the world. It is a broad and relative concept and there is few consistent medical data to validate its benefits. In this manner, this is the first clinical trial in Brazil questioning the safety of the of minimally invasive surgery to treat incidental cerebral aneurysms of the anterior circulation. For countries like Brazil, the indirect demonstration of reduction in hospital costs through lower hospital stays is a breakthrough to provide better health for the entire population.
Patients with the diagnosis of incidental brain aneurysms of the anterior circulation will be recruited from the spontaneous demand of the Hospital das Clínicas of University of São Paulo Medical School. The investigators expect to recruit 60 patients for the experimental group and 60 for the control group.
In the study group patients will be submitted to a minimally invasive approach (transpalpebral mini fronto-orbital craniotomy or modified minipterional craniotomy). All patients in this group will be submitted to surgery starting at 8 o'clock in the morning. After 6 hours of the end of surgery, all patients will have a control CT scan and if the result is adequate, they are going to be discharged from the ICU with no IV drugs. The hospital discharge will be in the next day. The control group are patients that will be submitted to a classical pterional craniotomy with hospital discharge occurring in 4-5 days.
All patients will be submitted to the standard care offered by the Hospital das Clinicas. All surgical and ambulatory data will be collected by the main investigators (Dr. Mauricio Mandel and Dr. Eberval Figueiredo). The adverse events will be promptly reported to the chair of the department and to the CAPPESQ (the ethics committee of the hospital).
Ambulatory data will be collected during the regular post operative medical appointments and a web based questionnaire. The post operative follow-up is unified in only one ambulatory center and day (thursdays mornings).
Statistical analysis will compare primary and secondary objectives of the two groups, as specified in the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transpalpebral Approach | Experimental | Procedure: Aneurysm ClippingAneurysm Clipping - Patients will be submitted to a Transpalpebral Approach to Unruptured Anterior Circulation Aneurysm and they will be discharged from the hospital on the next day. |
| NanoPterional Approach | Experimental | Procedure: Aneurysm ClippingAneurysm Clipping - Patients will be submitted to a Modified MiniPterional Approach (Nanopterional) to Unruptured Anterior Circulation Aneurysm and they will be discharged from the hospital on the next day. |
| Classical Pterional Craniotomy | Sham comparator | Procedure: Aneurysm ClippingAneurysm Clipping - Patients will be submitted to a Classical Pterional Approach to Unruptured Anterior Circulation Aneurysm and they will be discharged from the hospital 4-5 days after the procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with the diagnosis of incidental unruptured cerebral aneurysms (4mm to 2cm)
Key exclusion criteria (6 listed)
- Patients who do not have adequate family care during the immediate post-operative period (the patient's family must commit to stay with the patient in the first five days after hospital discharge)
- Patients who are unable to communicate by telephone
- People with cardiovascular disease, liver or kidney failure.
- Pregnant women or breastfeeding
- Patients with coagulation abnormalities
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 |
|---|---|---|
| Aneurysm ClippingAll Patients will be submitted to a surgical intervention in order to clip their unruptured brain aneurysm | Procedure or surgery | Classical Pterional Craniotomy, NanoPterional Approach, Transpalpebral Approach |
Primary outcome
Effective Aneurysm Clipping (no residual cerebral aneurysm)
Time frame: 3 months after surgery
All patients will be submitted to a post operative angiography to asses the presence of residual cerebral aneurysm after clipping.
5 secondary outcomes
All Cause Mortality
Time frame: 1 year
Neurological Outcome
Time frame: 1 year
Cosmetic Outcome
Time frame: 1 year
Surgical Safety assessed by number and description of Surgical Complications (infection rate, postoperative epidural/ contusional hematomas, number of reoperations, need of blood transfusion)
Time frame: 1 year
Early Hospital Discharge
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Background: PubMed 17171150Ohjimi H, Taniguchi Y, Tanahashi S, Era K, Fukushima T. Accessing the Orbital Roof via an Eyelid Incision: The Transpalpebral Approach. Skull Base Surg. 2000;10(4):211-6. doi: 10.1055/s-2000-9337.
- Background: PubMed 18671651Andaluz N, Romano A, Reddy LV, Zuccarello M. Eyelid approach to the anterior cranial base. J Neurosurg. 2008 Aug;109(2):341-6. doi: 10.3171/JNS/2008/109/8/0341.
- Background: PubMed 21499147Abdel Aziz KM, Bhatia S, Tantawy MH, Sekula R, Keller JT, Froelich S, Happ E. Minimally invasive transpalpebral "eyelid" approach to the anterior cranial base. Neurosurgery. 2011 Dec;69(2 Suppl Operative):ons195-206; discussion 206-7. doi: 10.1227/NEU.0b013e31821c3ea3.
- Background: PubMed 17041490Figueiredo EG, Deshmukh V, Nakaji P, Deshmukh P, Crusius MU, Crawford N, Spetzler RF, Preul MC. An anatomical evaluation of the mini-supraorbital approach and comparison with standard craniotomies. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS212-20; discussion ONS220. doi: 10.1227/01.NEU.0000223365.55701.F2.
- Background: PubMed 18091240Figueiredo EG, Deshmukh P, Nakaji P, Crusius MU, Crawford N, Spetzler RF, Preul MC. The minipterional craniotomy: technical description and anatomic assessment. Neurosurgery. 2007 Nov;61(5 Suppl 2):256-64; discussion 264-5. doi: 10.1227/01.neu.0000303978.11752.45.
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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.
Eberval G Figueiredo, MD, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aneurysm Clipping in people with Cerebral Aneurysm and Aneurysm, Middle Cerebral Artery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 1 inclusion and 6 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 26 Jan 2015. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 Mauricio Mandel, MD (55 11 996299224, mauricio.mandel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Aneurysm Clipping (no residual cerebral aneurysm) (time frame: 3 months after surgery). 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 NCT02345395, which also lists 5 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 26 Jan 2015.