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Comparative Study Between Different Approaches to CPA-petroclival Meningiomas

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ClinicalTrials.gov Identifier: NCT03462914
Recruitment Status : Unknown
Verified March 2018 by shady abdel raheem hassan, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
shady abdel raheem hassan, Assiut University

Brief Summary:

• Give an effective treatment for CPA-petroclival meningiomas and can detect the best approach for these tumors.

. Improve the outcome of these patients and decease rate of recurrence.


Condition or disease
Brain Neoplasms

Detailed Description:

There are several lesions arising in the petroclival region. The most frequent tumor is the petroclival meningioma, followed by chondrosarcomas, chordomas, schwannomas of the cranial nerves V and VII, and other malignant tumors [1, 2, 3, 4, 5].

Petroclival meningiomas are tumors of the skull base that present a formidable challenge to surgical resection because of their deep location and relationship to vital neurovascular structures. In the majority of the cases they are benign tumors, but may involve or infiltrate the skull base bone, the dura mater, the brainstem, and all important neurovascular structures of this region. The petroclival region comprises the anatomical location of the body of the sphenoid bone, the anterior central portion of the occipital bone, and is bordered on the lateral aspect by the petrous apex. The roof of this space is formed by the petroclival ligaments and the tentorium. This space contains important neurovascular structures that are frequently involved or displaced by the tumor in a variable pattern. The basilar artery with its branches may be embedded or displaced by the meningioma. The petrosal vein is often displaced posteriorly by the tumor. Cranial nerves III and IV are usually displaced upwardly and the nerve VI is often surrounded by tumor. Petroclival meningiomas have their origin medial to cranial nerves V, VII, VIII, IX, X, and XI, and reach the tentorium . They frequently extend to the middle cranial fossa, cavernous sinus, prepontine space, and down to the foramen magnum. These tumors frequently compress the brainstem making total removal very difficult or impossible without neurologic deficits. cerebellopontine angle (CPA) and low clivus meningiomas may reach these areas. These lesions usually need different surgical approaches as transpetrosal approach ( anterior, modified and combined ) and retrosigmoid approach

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Comparative Study Between Different Approaches to CPA -Petroclival Meningiomas
Estimated Study Start Date : March 15, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The success rate of surgery [ Time Frame: 1 year ]
    complete resection of the tumor



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with meningioma
Criteria

Inclusion Criteria:

  • Patient with a single lesion .
  • Patient with a denovo lesion.

Exclusion Criteria:

  • Patient with recurrent lesions.
  • Patient with lesions after adjuvant therapy.
Additional Information:

Publications:
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Responsible Party: shady abdel raheem hassan, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03462914    
Other Study ID Numbers: CPA-petroclival meningiomas
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningioma
Brain Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases