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Evaluation of the Pravalence of Rathke's Cleft Cyst of Children Under 15 Years (PREVA-KPR)

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ClinicalTrials.gov Identifier: NCT03975712
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
The goal of the study was to evaluate the pravalence of Rathke's Cleft Cyst of children under 15 years of age and demonstrate that their prevalence is higher than for patients over 15 years of age, due to their embryonic origin. It is also aimed to describe their aspect on MRI and evaluate the interobserver agreement in the detection of Rathke's Cleft Cyst.

Condition or disease Intervention/treatment
Rathke's Cleft Cyst Other: Not applicable, no intervention

Detailed Description:

Rathke's cleft cysts (RCC) are benign cystic lesions in the sellar region and correspond to embryonic remnants of the Rathke's pouch. The prevalence of RCC in the literature is higher in adults than in children, but the data for children is limited and outdated. The hypothesis is that the frequency of RCC has been underestimated in children and that it actually decreases with age, especially in adults. The main objective of this descriptive study is to study the prevalence and signal of RCC in children under 15 years of age.

460 encephalic MRIs of children under 15 years of age comprising at least one sagittal sequence without T1-weighted injection and/or a T2 sagittal sequence adapted to the study of the pituitary gland, were analyzed retrospectively. Examination analyses was performed blindly by two radiologists for serous RCC, hypersignal on T2-weighted and isosignal T1-weighted sequences, and mucosal RCC, hyposignal on T2-weighted sequences and hyper or isosignal on T1-weighted sequences. The results were consensually read in case of disagreement on the presence or absence of an RCC.

Of the 460 patients included, the prevalence of RCC was 3% (14/460). 21% of the RCC cases (3/14) were serous and 79% (11/14) were mucosal. Of the 14 patients with RCC, a post-pituitary cyst was also found. The interobserver agreement was strong with a Cohen kappa coefficient of 0.85.

The prevalence of RCC in children under 15 years of age (3%) is higher than that described in the literature (1.2%) and is close to that of adults (3.9%). RCCs are thus intra-sellar lesions of relatively frequent discovery in children, i.e. to identify in order to not erroneously lead to a differential diagnosis including tumors which would lead to a different prognosis, management, and follow-up.


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Study Type : Observational
Actual Enrollment : 460 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Pravalence of Rathke's Cleft Cyst of Children Under 15 Years
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Intervention Details:
  • Other: Not applicable, no intervention
    Not applicable, no intervention


Primary Outcome Measures :
  1. Presence or absence of a strictly intra-pituitary cystic lesion which localization and signal was compatible with an RCC, which type was defined according to its signal [ Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account ]

Secondary Outcome Measures :
  1. Maximum anteroposterior diameter (parallel to the bi-callous plane) of the cyst measured in sagittal section [ Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account ]
  2. Cyst signal on T2-weighted spin echo sequence compared to cerebrospinal fluid (hypo / iso / hyper signal) and T1-weighted compared to cerebral white matter (hypo / iso / hyper signal) [ Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account ]
  3. Motive for which brain MRI was performed [ Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account ]

    The motive can be:

    • benign tumoral pathology
    • neurological manifestations
    • traumatic pathologies
    • other pathologies (deterioration of the general state, exophthalmia).

  4. Dimensions of pituitary [ Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
children aged 15 or under at the time that an MRI was performed exploring the sellar region
Criteria

Inclusion Criteria:

  • children aged 15 or under at the time that an MRI was performed exploring the sellar region
  • MRI with at least T1 spin echo (SE) sagittal slices with a slice thickness of 2.5 or 3 mm with inter-slice spacing of 0.3 mm and T2 SE with a slice thickness of 2 mm and inter-slice spacing of 0.2 mm.

Exclusion Criteria:

  • Patients with incomplete MRI protocol
  • Patients whose MRI images had artifacts (patient movement, presence of dental material)
  • Patients with suspected pituitary pathology due to endocrine symptomatology (growth retardation, puberty delay, diabetes insipidus) that could be attributed to an intrasellar injury were also excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975712


Locations
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France
Centre Hospitalier Universitaire
Besançon, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03975712     History of Changes
Other Study ID Numbers: CHU de Besançon
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019
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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Cysts
Central Nervous System Cysts
Neoplasms
Pathological Conditions, Anatomical
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities