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
|Condition or disease||Intervention/treatment|
|Rathke's Cleft Cyst||Other: Not applicable, no intervention|
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The prevalence of RCC in the literature is higher in adults than in children, but the data for children is limited and outdated.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.
|Study Type :||Observational|
|Actual Enrollment :||460 participants|
|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|
- Other: Not applicable, no intervention
Not applicable, no intervention
- 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 ]
- 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 ]
- 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 ]
- 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).
- Dimensions of pituitary [ Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account ]
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
|Centre Hospitalier Universitaire|