Pituitary SurgeryCopeptin-surgNCT04326569
Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery
A study testing Blood sample in people with Pituitary Surgery, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Surgery
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2022to 18 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of the Copeptine Dosage in Diagnosis of Post-operative Insipidus Diabetes After Transsphenoidal 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).
Read more
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.
Read the 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.
- Conditions
- Pituitary Surgery
- Being tested
- Blood sample
- Keywords
- Pituitary surgery, post-operative insipidus diabetes, copeptin
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample to quantify copeptin
| Study group | Role | What they receive |
|---|---|---|
| adults with trans-sphenoidal endoscopic pituitary surgery | Experimental | adult with trans-sphenoidal endoscopic pituitary surgery for tumour of the sellar region Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Copeptin dosage
Immunoluminometric assay TRACE of the copeptin in pmol/l (Thermofischer)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start3 Jan 2022
- Primary completion18 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary SurgeryStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326569
- Sponsor's protocol ID
- PA20033
- Acronym
- Copeptin-surg
- Status last verified
- Jun 2024
- First submitted
- 26 Mar 2020
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Copeptine Dosage in Diagnosis of Post-operative Insipidus Diabetes After Transsphenoidal Pituitary Surgery
- ClinicalTrials.gov ID
- NCT04326569
- Acronym / sponsor ID
- Copeptin-surg / PA20033
- Conditions
- Pituitary Surgery
- Keywords
- Pituitary surgery, post-operative insipidus diabetes, copeptin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults with trans-sphenoidal endoscopic pituitary surgery | Experimental | Other: Blood sampleadult with trans-sphenoidal endoscopic pituitary surgery for tumour of the sellar region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood sample to quantify copeptin | Other | adults with trans-sphenoidal endoscopic pituitary surgery |
Primary outcome
Copeptin dosage
Time frame: Day 1
Immunoluminometric assay TRACE of the copeptin in pmol/l (Thermofischer)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Pituitary Surgery, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Copeptin dosage (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.