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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04326569
Other study ID # PA20033
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2022
Est. completion date March 18, 2024

Study information

Verified date June 2024
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Endoscopic trans-sphenoidal pituitary endoscopic surgery is one of the main axes of management of tumours of the sellar region. Central diabetes insipidus is a frequent complication of endoscopic trans-sphenoidal pituitary endoscopic surgery, with a prevalence of up to 30% of cases. It is the consequence of insufficient secretion of the anti-diuretic hormone arginine vasopressin (AVP) by the posterior pituitary (Melmed et al, 2017). In the absence of specific treatment, diabetes insipidus can lead to severe ionic and osmotic disorders, mainly acute dehydration with the risk of severe consequences particularly neurological. Monitoring for the appearance of diabetes insipidus is therefore necessary from the immediate post-operative period. To date, diabetes insipidus is initially suspected before the appearance of major polyuria. Several biological assays (urinary density, natraemia, urinary osmolarity and plasma) can help to confirm the diagnosis, but the sensitivity and specificity of these biomarkers remains quite low for this indication. The determination of MVA is difficult because this hormone is unstable ex vivo. To date, its use in current practice remains complicated. MVA and copeptin are derived from the same precursor and are therefore co-secreted by the pituitary gland in equimolar proportions. Copeptin has a relatively short in vivo half-life of about 25 minutes, as does MVA, but is more stable in vitro when blood has been drawn. Its use in the early diagnosis of diabetes insipidus after pituitary surgery could therefore be of interest.


Description:

Objective is to study the interest of copeptin dosage as an early predictive marker for the diagnosis of post-operatice diabetes insipidus in trans-sphenoidal endoscopic pituitary surgery.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date March 18, 2024
Est. primary completion date March 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility inclusion criteria : adult patient patient undergoing pituitary surgery for tumour of the sellar region patient consenting to participate to the study patient enrolled in the national healthcare insurance program exclusion criteria : Patient with preoperative diabetes insipidus. Patient undergoing pituitary surgery for suspicion of craniopharyngioma Patient undergoing pituitary surgery for pituitary metastases Patient under 18 years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sample
Blood sample to quantify copeptin

Locations

Country Name City State
France Damien JOLLY Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Copeptin dosage Immunoluminometric assay TRACE of the copeptin in pmol/l (Thermofischer) Day 1