Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery (Copeptin-surg)
Primary Purpose
Pituitary Surgery
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Pituitary Surgery focused on measuring Pituitary surgery, post-operative insipidus diabetes, copeptin
Eligibility Criteria
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
Sites / Locations
- Damien JOLLY
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adults with trans-sphenoidal endoscopic pituitary surgery
Arm Description
adult with trans-sphenoidal endoscopic pituitary surgery for tumour of the sellar region
Outcomes
Primary Outcome Measures
Copeptin dosage
Immunoluminometric assay TRACE of the copeptin in pmol/l (Thermofischer)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04326569
Brief Title
Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery
Acronym
Copeptin-surg
Official Title
Interest of the Copeptine Dosage in Diagnosis of Post-operative Insipidus Diabetes After Transsphenoidal Pituitary Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Surgery
Keywords
Pituitary surgery, post-operative insipidus diabetes, copeptin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
adults with trans-sphenoidal endoscopic pituitary surgery
Arm Type
Experimental
Arm Description
adult with trans-sphenoidal endoscopic pituitary surgery for tumour of the sellar region
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Blood sample to quantify copeptin
Primary Outcome Measure Information:
Title
Copeptin dosage
Description
Immunoluminometric assay TRACE of the copeptin in pmol/l (Thermofischer)
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bénédicte DECOUDIER
Phone
03 10 73 61 65
Email
bdecoudier@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénédicte DECOUDIER
Phone
03 10 73 61 65
Ext
0033
Email
bdecoudier@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery
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