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Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery

Interest of the Copeptine Dosage in Diagnosis of Post-operative Insipidus Diabetes After Transsphenoidal Pituitary Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04326569
Acronym
Copeptin-surg
Enrollment
57
Registered
2020-03-30
Start date
2022-01-03
Completion date
2024-03-18
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Surgery

Keywords

Pituitary surgery, post-operative insipidus diabetes, copeptin

Brief 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.

Detailed 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.

Interventions

OTHERBlood sample

Blood sample to quantify copeptin

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Copeptin dosageDay 1Immunoluminometric assay TRACE of the copeptin in pmol/l (Thermofischer)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026