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Completed

NCT Number: NCT04326569

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damien JOLLY

Reims, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

Blood sample to quantify copeptin

Primary outcomes

  1. Copeptin dosage

    Time frame: Day 1

    Immunoluminometric assay TRACE of the copeptin in pmol/l (Thermofischer)

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: Copeptin-surg

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2020
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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