Parathyroid Function Low Adverse EventNCT02249780
Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy
A study testing Postoperative parathyroid function test, No postoperative parathyroid dosage and supplementation and ICG parathyroid angiography in people with Parathyroid Function Low Adverse Event, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation surgery. Create an objective basis for the decision whether or not to transplant the parathyroid glands. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parathyroid Function Low Adverse Event
- What is being tested?
- Postoperative parathyroid function test, No postoperative parathyroid dosage and supplementation and ICG parathyroid angiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to Feb 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing total thyroidectomy or a totalisation thyroid procedure.
- Patients capable of understanding and able to understand the study.
- Values visually 2 and ICG 2
Who cannot join
- Parathyroid disease or prior parathyroidectomy
- Lack of informed consent
- Altered mental status of the patient.
- ICG values <2.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospitals Geneva
Geneva, Canton of Geneva, 1205
About this study
Official title: The Use of Indocyanine Green Fluorescence to Assses the Vascularisation of the Parathyroid Glands During Thyroid Surgery
Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation surgery. Create an objective basis for the decision whether or not to transplant the parathyroid glands. Avoide postoperative serum calcium and parathyroid hormone dosages, and thus abstention of systematic supplementation with calcium and vitamin D in case of good perfusion.
Read the detailed description
Parathyroid intraoperative indocyanine green (ICG) angiography is a new concept. To simplify the procedure the investigators have classified images into three categories: ICG 2: good blood supply (the gland has a white color); ICG 1: traumatic gland (the gland has a grayish color) and ICG 0: the gland is not vascularized (she has a black color). The investigators have applied the same criteria for visual values.
The investigators will randomize 138 patients with good ICG test values (at least one gland that is visually ≥1 and ICG 2): 69 will be subject to the usual postoperative care in the investigators service: 24 hours monitoring with dosage of calcium and PTH in the morning on postoperative day 1 and routine supplementation with Calcimagon D3 Forte (1g Calcium and 800 IU of 25-OH-vitamin D) BD by mouth until postoperative follow-up appointment, which takes place between day 10 and 15. Depending on the results of blood tests patients will also be given Rocaltrol substitution (1, 25-OH-Vitamin D) 0.5mcg BD. The remaining patients will be monitored 24 hours in hospital looking for clinical signs and symptoms of hypocalcemia but without any blood dosage or systematic supplementation. If signs and / or symptoms of hypocalcemia develop (tingling, muscle spasms, Chvostek sign), a blood test will be performed and patients will be substituted by the usual protocol. All patients will be reviewed at 10 - 15 days of the intervention with the relevant balance sheet.
- Conditions
- Parathyroid Function Low Adverse Event
- Being tested
- Postoperative parathyroid function test, No postoperative parathyroid dosage and supplementation, ICG parathyroid angiography, Parathyroid supplementation
- Keywords
- Parathyroid gland angiography, Parathyroid gland indocyanine green angiography, Parathyroid gland indocyanine green fluoroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative parathyroid function testProcedure or surgery
Calcium and parathormone dosage at 24 hours and ten day after surgery
No postoperative parathyroid dosage and supplementationProcedure or surgery
Also called Parathiroid function testing
The patients will be clinically followed for 24 hours after surgery and caclium and parathormone dosage will be done at ten days after surgery. No supplementation will be given.
ICG parathyroid angiographyProcedure or surgery
Also called Indoyanine green angiography, Indoyanine green fluoroscopy
Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.
Parathyroid supplementationDrug
Also called Hypocalcemia post thyroidectomy treatment
Supplementration with Calcimagon D3 Forte (1gr Calcium and 800 IU of 25-OH-vitamin D) from surgery day to up to 10 days afeter surgery.
| Study group | Role | What they receive |
|---|---|---|
| New treatment | Experimental | In patients with at least one well perfused parathyroid gland on ICG parathyroid angiography, no postoperative parathyroid dosage and supplementation will be done. Calcium and parathormone dosage will be done 10 days after surgery. Receives: Procedure: No postoperative parathyroid dosage and supplementation; Procedure: ICG parathyroid angiography |
| Standart treatment | Active comparator | In those patients in whom at least on of the four parathyroid glands is well perused, postoperative parathyroid function test and parathyroid supplementation will be done. Calcium and parathormone dosage will be done at 24 hours and 10 days after surgery. Prophylactic supplementation of calcium and Vitamin D will be given. Receives: Procedure: Postoperative parathyroid function test; Procedure: ICG parathyroid angiography; Drug: Parathyroid supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative parathyroid function
All patients will be reviewed at 10-15 days after surgery and blood tests will be done. Investigators will check the number of patients with serum calcium and parathyroid hormone in normal ranges at ten days after surgery in both arms of the study. Low parathyroid function will be diagnosed when corrected calcium < 2mmol/l, and PTH < 1.1 pmol/l.
Measured: 10 days after surgery
Secondary outcomes (1)
Calcium and parathormone dosage after surgery
Number of patients with good calcium and parathormone values at 10 days after surgery without calcium and vitamin D supplementation in the selected group.
Measured: 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parathyroid Function Low Adverse EventStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Principal investigator, JORDI VIDAL FORTUNY, University Hospital, Geneva
- Investigators
- Frédéric Triponez, Professor, Study director, University Hospital, GenevaWolfram Karenovics, SPR, Principal investigator, University Hospital, GenevaFrédéric Ris, Consultant, Principal investigator, University Hospital, GenevaValentina Belfontali, Resident, Principal investigator, University Hospital, GenevaJordi Vidal Fortuny, SPR, Study chair, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249780
- Sponsor's protocol ID
- 14-160
- Status last verified
- Sep 2014
- First submitted
- 15 Sep 2014
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vidal Fortuny J, Sadowski SM, Belfontali V, Guigard S, Poncet A, Ris F, Karenovics W, Triponez F. Randomized clinical trial of intraoperative parathyroid gland angiography with indocyanine green fluorescence predicting parathyroid function after thyroid surgery. Br J Surg. 2018 Mar;105(4):350-357. doi: 10.1002/bjs.10783. Epub 2018 Feb 6.
PubMed 29405252
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Indocyanine Green Fluorescence to Assses the Vascularisation of the Parathyroid Glands During Thyroid Surgery
- ClinicalTrials.gov ID
- NCT02249780
- Acronym / sponsor ID
- 14-160
- Conditions
- Parathyroid Function Low Adverse Event
- Keywords
- Parathyroid gland angiography, Parathyroid gland indocyanine green angiography, Parathyroid gland indocyanine green fluoroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- Sep 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Sep 2014 (estimated)
- 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.
Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation surgery. Create an objective basis for the decision whether or not to transplant the parathyroid glands. Avoide postoperative serum calcium and parathyroid hormone dosages, and thus abstention of systematic supplementation with calcium and vitamin D in case of good perfusion.
Detailed description
Parathyroid intraoperative indocyanine green (ICG) angiography is a new concept. To simplify the procedure the investigators have classified images into three categories: ICG 2: good blood supply (the gland has a white color); ICG 1: traumatic gland (the gland has a grayish color) and ICG 0: the gland is not vascularized (she has a black color). The investigators have applied the same criteria for visual values.
The investigators will randomize 138 patients with good ICG test values (at least one gland that is visually ≥1 and ICG 2): 69 will be subject to the usual postoperative care in the investigators service: 24 hours monitoring with dosage of calcium and PTH in the morning on postoperative day 1 and routine supplementation with Calcimagon D3 Forte (1g Calcium and 800 IU of 25-OH-vitamin D) BD by mouth until postoperative follow-up appointment, which takes place between day 10 and 15. Depending on the results of blood tests patients will also be given Rocaltrol substitution (1, 25-OH-Vitamin D) 0.5mcg BD. The remaining patients will be monitored 24 hours in hospital looking for clinical signs and symptoms of hypocalcemia but without any blood dosage or systematic supplementation. If signs and / or symptoms of hypocalcemia develop (tingling, muscle spasms, Chvostek sign), a blood test will be performed and patients will be substituted by the usual protocol. All patients will be reviewed at 10 - 15 days of the intervention with the relevant balance sheet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New treatment | Experimental | Procedure: No postoperative parathyroid dosage and supplementation, Procedure: ICG parathyroid angiographyIn patients with at least one well perfused parathyroid gland on ICG parathyroid angiography, no postoperative parathyroid dosage and supplementation will be done. Calcium and parathormone dosage will be done 10 days after surgery. |
| Standart treatment | Active comparator | Procedure: Postoperative parathyroid function test, Procedure: ICG parathyroid angiography, Drug: Parathyroid supplementationIn those patients in whom at least on of the four parathyroid glands is well perused, postoperative parathyroid function test and parathyroid supplementation will be done. Calcium and parathormone dosage will be done at 24 hours and 10 days after surgery. Prophylactic supplementation of calcium and Vitamin D will be given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients undergoing total thyroidectomy or a totalisation thyroid procedure.
- Patients capable of understanding and able to understand the study.
- Values visually 2 and ICG 2
Key exclusion criteria (4 listed)
- Parathyroid disease or prior parathyroidectomy
- Lack of informed consent
- Altered mental status of the patient.
- ICG values <2.
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 |
|---|---|---|
| Postoperative parathyroid function testCalcium and parathormone dosage at 24 hours and ten day after surgery | Procedure or surgery | Standart treatment |
| No postoperative parathyroid dosage and supplementationAlso: Parathiroid function testingThe patients will be clinically followed for 24 hours after surgery and caclium and parathormone dosage will be done at ten days after surgery. No supplementation will be given. | Procedure or surgery | New treatment |
| ICG parathyroid angiographyAlso: Indoyanine green angiography, Indoyanine green fluoroscopyInjection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal. | Procedure or surgery | New treatment, Standart treatment |
| Parathyroid supplementationAlso: Hypocalcemia post thyroidectomy treatmentSupplementration with Calcimagon D3 Forte (1gr Calcium and 800 IU of 25-OH-vitamin D) from surgery day to up to 10 days afeter surgery. | Drug | Standart treatment |
Primary outcome
Postoperative parathyroid function
Time frame: 10 days after surgery
All patients will be reviewed at 10-15 days after surgery and blood tests will be done. Investigators will check the number of patients with serum calcium and parathyroid hormone in normal ranges at ten days after surgery in both arms of the study. Low parathyroid function will be diagnosed when corrected calcium < 2mmol/l, and PTH < 1.1 pmol/l.
1 secondary outcome
Calcium and parathormone dosage after surgery
Time frame: 10 days after surgery
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 18 Apr 2016.
- Derived from this study: PubMed 29405252Vidal Fortuny J, Sadowski SM, Belfontali V, Guigard S, Poncet A, Ris F, Karenovics W, Triponez F. Randomized clinical trial of intraoperative parathyroid gland angiography with indocyanine green fluorescence predicting parathyroid function after thyroid surgery. Br J Surg. 2018 Mar;105(4):350-357. doi: 10.1002/bjs.10783. Epub 2018 Feb 6.
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.
Frédéric Triponez, Professor study director
University Hospital, Geneva
Wolfram Karenovics, SPR principal investigator
University Hospital, Geneva
Frédéric Ris, Consultant principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative parathyroid function test, No postoperative parathyroid dosage and supplementation and ICG parathyroid angiography in people with Parathyroid Function Low Adverse Event, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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 18 Apr 2016. 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 Switzerland. 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?
Postoperative parathyroid function (time frame: 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02249780, which also lists 1 linked publication.
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 18 Apr 2016.