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

NCT04326569 | Completed

• 1 other identifier: PA20033
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Surgery

Keywords

Pituitary surgery; post-operative insipidus diabetes; copeptin

Outcome Measures

Primary Outcomes (1)

• Copeptin dosage

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

  Day 1

Study Arms (1)

adults with trans-sphenoidal endoscopic pituitary surgery

EXPERIMENTAL

adult with trans-sphenoidal endoscopic pituitary surgery for tumour of the sellar region

Other: Blood sample

Interventions

Blood sample OTHER

Blood sample to quantify copeptin

adults with trans-sphenoidal endoscopic pituitary surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: January 3, 2022
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

FR (1)