Supratentorial Brain TumorNCT01864499
Perioperative Evaluation of Intracranial Hypertension by Ultrasound Measurement of Variations in the Diameter of the Sheath of the Optic Nerve in the Excision of a Tumor or Biopsy Supratentorial Brain
A study testing ultrasound measurement of variations in the diameter of the sheath of the optic nerve in people with Supratentorial Brain Tumor, run by Poitiers University Hospital.
Trial summary
Neurosurgery for supratentorial brain tumor is frequently associated with preoperative intracranial hypertension. The evaluation of intracranial pressure is available noninvasively by measuring the diameter of the optic nerve sheath ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Supratentorial Brain Tumor
- What is being tested?
- ultrasound measurement of variations in the diameter of the sheath of the optic nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Jun 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 99 years
- All sexes
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Hospitalized for surgery of intracerebral tumors in the study group.
- Hospitalized for a biopsy of intracerebral tumor lesion in the control group.
Who cannot join
- Age <18 years
- Enucleation Prohibited to the achievement of an ocular ultrasound
- Hypersensitivity to gel
- Eye Wound
- Massive facial fracture
- Skin Infection Site
About this study
Neurosurgery for supratentorial brain tumor is frequently associated with preoperative intracranial hypertension. The evaluation of intracranial pressure is available noninvasively by measuring the diameter of the optic nerve sheath ultrasound.
The evaluation of intracranial pressure by measuring the DNO in perioperative is not described in the literature. The investigators propose a pilot study to assess intracranial pressure perioperative surgery for supratentorial brain tumor. The investigators consider a diameter of the optic nerve sheath as normal and predictive of intracranial pressure below 20 mm Hg when less than 5.7 mm (on the average of two measurements on each eye). DNO the normal healthy adult unanesthetized is 5 mm.
Read more
The main objective of the study is to compare the mean change in diameter of the optic nerve between the postoperative and D2 between groups of patients undergoing resection of a brain tumor and patients undergoing biopsy brain tumor.
Pilot Study: Prospective, single-center, controlled, non-randomized, the number of patients is estimated according to the recruiting capabilities of neurosurgery for this type of patient in the institution, A total of 40 patients: 20 patients Tumor Resection, control group: 20 patients Biopsy Brain Tumor.
- Conditions
- Supratentorial Brain Tumor
- Being tested
- ultrasound measurement of variations in the diameter of the sheath of the optic nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound measurement of variations in the diameter of the sheath of the optic nerveProcedure or surgery
pre-and postoperative optic nerve and J2 and J5 for all patients
| Study group | Role | What they receive |
|---|---|---|
| Tumor Resection | Experimental | Not described Receives: Procedure: ultrasound measurement of variations in the diameter of the sheath of the optic nerve |
| Biopsy Brain Tumor | Active comparator | Not described Receives: Procedure: ultrasound measurement of variations in the diameter of the sheath of the optic nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean changes that the sheath of postoperative optic nerve
Difference in mean changes that the sheath of postoperative optic nerve and J2 between groups of patients undergoing resection of brain tumor patients undergoing biopsy for brain tumor
Measured: 2 days
Secondary outcomes (1)
Difference in diameter of the sheath of the pre-and postoperative optic nerve
Difference in diameter of the sheath of the pre-and postoperative optic nerve and J2 and J5 for all patients undergoing resection of brain tumor patients undergoing biopsy for brain tumor.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supratentorial Brain TumorStudies of the same condition, open and under way.
- More trials run by Poitiers University 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
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand DEBAENE, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864499
- Sponsor's protocol ID
- DINO-NEURO
- Status last verified
- Oct 2016
- First submitted
- 14 May 2013
- Last updated
- 11 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Evaluation of Intracranial Hypertension by Ultrasound Measurement of Variations in the Diameter of the Sheath of the Optic Nerve in the Excision of a Tumor or Biopsy Supratentorial Brain
- ClinicalTrials.gov ID
- NCT01864499
- Acronym / sponsor ID
- DINO-NEURO
- Conditions
- Supratentorial Brain Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Primary completion
- Jun 2015 (actual)
- First posted
- 29 May 2013 (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.
Neurosurgery for supratentorial brain tumor is frequently associated with preoperative intracranial hypertension. The evaluation of intracranial pressure is available noninvasively by measuring the diameter of the optic nerve sheath ultrasound.
The evaluation of intracranial pressure by measuring the DNO in perioperative is not described in the literature. The investigators propose a pilot study to assess intracranial pressure perioperative surgery for supratentorial brain tumor. The investigators consider a diameter of the optic nerve sheath as normal and predictive of intracranial pressure below 20 mm Hg when less than 5.7 mm (on the average of two measurements on each eye). DNO the normal healthy adult unanesthetized is 5 mm.
The main objective of the study is to compare the mean change in diameter of the optic nerve between the postoperative and D2 between groups of patients undergoing resection of a brain tumor and patients undergoing biopsy brain tumor.
Pilot Study: Prospective, single-center, controlled, non-randomized, the number of patients is estimated according to the recruiting capabilities of neurosurgery for this type of patient in the institution, A total of 40 patients: 20 patients Tumor Resection, control group: 20 patients Biopsy Brain Tumor.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor Resection | Experimental | Procedure: ultrasound measurement of variations in the diameter of the sheath of the optic nerve |
| Biopsy Brain Tumor | Active comparator | Procedure: ultrasound measurement of variations in the diameter of the sheath of the optic nerve |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Hospitalized for surgery of intracerebral tumors in the study group.
- Hospitalized for a biopsy of intracerebral tumor lesion in the control group.
Key exclusion criteria (6 listed)
- Age <18 years
- Enucleation Prohibited to the achievement of an ocular ultrasound
- Hypersensitivity to gel
- Eye Wound
- Massive facial fracture
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 |
|---|---|---|
| ultrasound measurement of variations in the diameter of the sheath of the optic nervepre-and postoperative optic nerve and J2 and J5 for all patients | Procedure or surgery | Biopsy Brain Tumor, Tumor Resection |
Primary outcome
Difference in mean changes that the sheath of postoperative optic nerve
Time frame: 2 days
Difference in mean changes that the sheath of postoperative optic nerve and J2 between groups of patients undergoing resection of brain tumor patients undergoing biopsy for brain tumor
1 secondary outcome
Difference in diameter of the sheath of the pre-and postoperative optic nerve
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
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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.
Bertrand DEBAENE principal investigator
Poitiers University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound measurement of variations in the diameter of the sheath of the optic nerve in people with Supratentorial Brain Tumor, run by Poitiers University Hospital.
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 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: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean changes that the sheath of postoperative optic nerve (time frame: 2 days). 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 11 Oct 2016.