NCT05781984

Brief 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 ?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

March 12, 2023

Last Update Submit

March 12, 2023

Conditions

Keywords

pineal region

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Microsurgical excision of pineal region tumor or endoscopic biopsy

Also known as: Endoscopic Biopsy

Eligibility Criteria

Age2 Months - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric population with age of 18 years old or younger diagnosed with pineal region tumor and fit for surgical intervention

You may qualify if:

  • All patients with pineal region tumors with age less than or equal to 18 years old and fit for surgical intervention

You may not qualify if:

  • patients with pineal region tumors older than 18 years old
  • and pediatric patients younger than 18 years ild and unfit for surgical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 21801980BACKGROUND
  • 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.

    PMID: 21676231BACKGROUND
  • 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.

    PMID: 17032562BACKGROUND
  • 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.

    PMID: 25113513BACKGROUND
  • 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.

    PMID: 19329865BACKGROUND
  • 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.

    PMID: 24604367BACKGROUND
  • 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.

    PMID: 21559151BACKGROUND
  • 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.

    PMID: 5925731BACKGROUND
  • Dandy WE. EXTIRPATION OF THE PINEAL BODY. J Exp Med. 1915 Aug 1;22(2):237-46. doi: 10.1084/jem.22.2.237.

    PMID: 19867913BACKGROUND
  • 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.

    PMID: 22381843BACKGROUND
  • 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.

    PMID: 34854993BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Mohamed Ahmed Alghriany, Master degree in Neurosurgery

CONTACT

Roshdy Abdelaziz Elkhayat, MD, Professor of Neurosurgery

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistan lecturer of Neurosurgery

Study Record Dates

First Submitted

March 12, 2023

First Posted

March 23, 2023

Study Start

April 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

March 23, 2023

Record last verified: 2023-03