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

NCT04326569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-06-13

No results posted yet for this study

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.

Conditions

  • Pituitary Surgery

Interventions

OTHER

Blood sample

Blood sample to quantify copeptin

Sponsors & Collaborators

  • CHU de Reims

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2024-03-18
Completion
2024-03-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04326569 on ClinicalTrials.gov