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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

Primary Purpose

Supratentorial Brain Tumor

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

ultrasound measurement of variations in the diameter of the sheath of the optic nerve

About this trial

This is an interventional trial for Supratentorial Brain Tumor

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

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.

Exclusion Criteria:

Age <18 years
Enucleation Prohibited to the achievement of an ocular ultrasound
Hypersensitivity to gel
Eye Wound
Massive facial fracture
Skin Infection Site

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tumor Resection

Biopsy Brain Tumor

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01864499

First Posted

May 14, 2013

Last Updated

October 10, 2016

Sponsor

Poitiers University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01864499

Brief 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

June 2015 (Actual)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poitiers University Hospital

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Supratentorial Brain Tumor

7. Study Design

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Arm Title

Tumor Resection

Arm Type

Experimental

Arm Title

Biopsy Brain Tumor

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

ultrasound measurement of variations in the diameter of the sheath of the optic nerve

Intervention Description

pre-and postoperative optic nerve and J2 and J5 for all patients

Primary Outcome Measure Information:

Title

Difference in mean changes that the sheath of postoperative optic nerve

Description

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

Time Frame

2 days

Secondary Outcome Measure Information:

Title

Difference in diameter of the sheath of the pre-and postoperative optic nerve

Description

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.

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Age <18 years Enucleation Prohibited to the achievement of an ocular ultrasound Hypersensitivity to gel Eye Wound Massive facial fracture Skin Infection Site

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bertrand DEBAENE

Organizational Affiliation

Poitiers University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

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