- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04326569
Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery (Copeptin-surg)
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).
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.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bénédicte DECOUDIER
- Phone Number: 03 10 73 61 65
- Email: bdecoudier@chu-reims.fr
Study Locations
-
-
-
Reims, France
- Damien JOLLY
-
Contact:
- Bénédicte DECOUDIER
- Phone Number: 0033 03 10 73 61 65
- Email: bdecoudier@chu-reims.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: adults with trans-sphenoidal endoscopic pituitary surgery
adult with trans-sphenoidal endoscopic pituitary surgery for tumour of the sellar region
|
Blood sample to quantify copeptin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Copeptin dosage
Time Frame: Day 1
|
Immunoluminometric assay TRACE of the copeptin in pmol/l (Thermofischer)
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA20033
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pituitary Surgery
-
Vanderbilt UniversityCompletedPituitary | Robotics | Sinus Surgery | Skull Base | Endonasal SurgeryUnited States
-
Khon Kaen UniversityUnknownVoice Quality | Endoscopic Pituitary SurgeryThailand
-
University Hospital, BrestUnknownSurgery--ComplicationsFrance
-
Göteborg UniversityUnknownSurgery | Pituitary Tumor BenignSweden
-
University of North Carolina, Chapel HillWithdrawnSurgery | Blood Loss | Pituitary Tumor
-
Huashan HospitalRecruitingPituitary Adenoma | SurgeryChina
-
Washington University School of MedicineActive, not recruitingSurgery | Hyponatremia | Pituitary | Pituitary Tumor | HyponatremicUnited States
-
Zhebao WuThe First Affiliated Hospital of Nanchang University; Shanghai Zhongshan Hospital and other collaboratorsUnknownQuality of Life | Pituitary Tumor | Endoscopic Surgery | Function of NoseChina
-
Chang Gung Memorial HospitalRecruitingPostoperative Complications | Enhanced Recovery After Surgery | Pituitary TumorTaiwan
-
Central Hospital, Nancy, FranceCompletedPituitary Adenoma | Surgery-ComplicationsFrance
Clinical Trials on Blood sample
-
Memorial Sloan Kettering Cancer CenterActive, not recruiting
-
Medical University of WarsawCompletedArthroplasty | Platelet Aggregation | Methylmethacrylate EmbolismPoland
-
Meir Medical CenterCompleted
-
Centre Hospitalier Universitaire de NīmesNot yet recruitingNarcolepsy Type 1 | Bacterial TranslocationFrance
-
The First Affiliated Hospital of Soochow UniversityRecruitingGraft Vs Host DiseaseChina
-
First Affiliated Hospital of Zhejiang UniversityRecruitingComplication | Hematologic Malignancy | Hematopoietic Stem Cell Transplantation | Chronic Graft-versus-host-diseaseChina
-
University Hospital, BordeauxMinistry for Health and Solidarity, FranceRecruitingImmune Thrombocytopenia | Autoimmune Hemolytic Anemia | Autoimmune NeutropeniaFrance
-
University Hospital, ToursCompletedMetastatic Prostate Cancer | Circulating Tumor DNAFrance
-
University Hospital, BordeauxActive, not recruitingSystemic Lupus Erythematosus | Systemic SclerodermaFrance
-
University Hospital, BordeauxCompletedRenal Function Disorder | Chronic Renal Diseases