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NCT05781984 Clinical Trial

Role of Surgery in Management of Pineal Region Tumors in Children

Brain Tumor Clinical Trial

Official title:
Role of Surgery in Management of Pineal Region Tumors in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05781984
Other study ID # Pineal Region Tumors
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2023
Est. completion date January 2024

Study information
Verified date March 2023
Source Assiut University
Contact Mohamed Ahmed Alghriany, Master degree in Neurosurgery
Phone +201009252897
Email vetchalg@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this observational study is to learn about the role of surgery with its different approaches and modalities in the management of pineal region tumors in pediatric population.the main question it aims to answer is : How can surgery affect the outcome in children with pineal region tumors ?

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date January 2024
Est. primary completion date December 2023
Accepts healthy volunteers
Gender All
Age group 2 Months to 18 Years
Eligibility Inclusion Criteria: - All patients with pineal region tumors with age less than or equal to 18 years old and fit for surgical intervention Exclusion Criteria: - patients with pineal region tumors older than 18 years old - and pediatric patients younger than 18 years ild and unfit for surgical intervention

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Microsugical Excsosion
Microsurgical excision of pineal region tumor or endoscopic biopsy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (11)

Behari S, Garg P, Jaiswal S, Nair A, Naval R, Jaiswal AK. Major surgical approaches to the posterior third ventricular region: A pictorial review. J Pediatr Neurosci. 2010 Jul;5(2):97-101. doi: 10.4103/1817-1745.76093. No abstract available. — View Citation

Blakeley JO, Grossman SA. Management of pineal region tumors. Curr Treat Options Oncol. 2006 Nov;7(6):505-16. doi: 10.1007/s11864-006-0025-6. — View Citation

Choudhry O, Gupta G, Prestigiacomo CJ. On the surgery of the seat of the soul: the pineal gland and the history of its surgical approaches. Neurosurg Clin N Am. 2011 Jul;22(3):321-33, vii. doi: 10.1016/j.nec.2011.04.001. — View Citation

Dandy WE. EXTIRPATION OF THE PINEAL BODY. J Exp Med. 1915 Aug 1;22(2):237-46. doi: 10.1084/jem.22.2.237. — View Citation

Li Y, Zhao G, Wang H, Zhu W, Qu L, Li Y, Yu J. Use of 3D-computed tomography angiography for planning the surgical removal of pineal region meningiomas using Poppen's approach: a report of ten cases and a literature review. World J Surg Oncol. 2011 Jun 15;9:64. doi: 10.1186/1477-7819-9-64. — View Citation

Masina R, Ansaripour A, Benes V, Berhouma M, Choque-Velasquez J, Eide PK, Fedorko S, Fleck S, Hernesniemi J, Koziarski A, Majovsky M, Podgorski A, Schroeder H, Teo C, Unterberg AW, Yeung JT, Kolias A, Santarius T. Surgical treatment of symptomatic pineal cysts without hydrocephalus-meta-analysis of the published literature. Acta Neurochir (Wien). 2022 Jan;164(1):61-77. doi: 10.1007/s00701-021-05054-0. Epub 2021 Dec 2. — View Citation

Morgenstern PF, Souweidane MM. Pineal region tumors: simultaneous endoscopic third ventriculostomy and tumor biopsy. World Neurosurg. 2013 Feb;79(2 Suppl):S18.e9-13. doi: 10.1016/j.wneu.2012.02.020. Epub 2012 Feb 10. — View Citation

Mori Y, Kobayashi T, Hasegawa T, Yoshida K, Kida Y. Stereotactic radiosurgery for pineal and related tumors. Prog Neurol Surg. 2009;23:106-118. doi: 10.1159/000210057. Epub 2009 Mar 23. — View Citation

Mottolese C, Szathmari A, Beuriat PA. Incidence of pineal tumours. A review of the literature. Neurochirurgie. 2015 Apr-Jun;61(2-3):65-9. doi: 10.1016/j.neuchi.2014.01.005. Epub 2014 Aug 10. — View Citation

Poppen JL. The right occipital approach to a pinealoma. J Neurosurg. 1966 Dec;25(6):706-10. doi: 10.3171/jns.1966.25.6.0706. No abstract available. — View Citation

Wang P, Mao Q, Wang W, Zhou LX, Liu YH. Gamma knife surgery for pineal region tumors: an alternative strategy for negative pathology. Arq Neuropsiquiatr. 2014 Feb;72(2):129-35. doi: 10.1590/0004-282X20130217. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary role of surgery and its effect in improving quality of life in children with pineal region tumors evaluation of effect of surgical management with its different approaches in improvement of quality of life and performance status using Karnofsky Performance score (KPS) and radiological imaging till referral to adjuvant therapy three years
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