Iatrogenic HypocalcemiaGuiArteNCT05573828
Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function
A study testing ICG angiography to show vascular map of parathyroid glands in people with Iatrogenic Hypocalcemia, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
Trial summary
Transient and/or permanent hypoparathyroidism is the most frequent complication after total thyroidectomy. The identification of the parathyroid glands and a correct dissection during thyroidectomy have been postulated as key factors for their preservation and, consequently, to prevent hypoparathyroidism. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Iatrogenic Hypocalcemia
- What is being tested?
- ICG angiography to show vascular map of parathyroid glands
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 2 sitesSpain
- Study dates
- 11 Oct 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age with a surgical indication for total thyroidectomy with or without central cervical lymph node dissection due to thyroid pathology.
- The patient or their guardian, where applicable, has the capacity to understand the study and agrees to participate in it, signing the corresponding informed consent document.
Who cannot join
- Previous surgical intervention on the thyroid or parathyroid gland.
- Associated hyperparathyroidism that requires associating a parathyroidectomy in the same surgical act.
- Patients with contraindications for the administration of ICG.
- Current drug use or alcohol abuse that could interfere with compliance with the study requirements.
- Participation in any other drug trials in the month prior to randomization.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital UIniversitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Pablo Moreno, 34 661214772, 25108pml@gmail.com
- Recruiting
Pablo Moreno Llorente
L'Hospitalet de Llobregat, Barcelona, 08907
Pablo Moreno, 661214772, 25108pml@gmail.com
About this study
Official title: Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. GuiArte Multicentric Randomized Study.
Transient and/or permanent hypoparathyroidism is the most frequent complication after total thyroidectomy. The identification of the parathyroid glands and a correct dissection during thyroidectomy have been postulated as key factors for their preservation and, consequently, to prevent hypoparathyroidism. The use of indocyanine green (ICG) fluorescence has reliably predicted parathyroid glands functionality in the immediate postoperative period. Recently, it is proposed that showing the vascular map of the parathyroid glands before performing the thyroidectomy by means of ICG angiography prevent the development of postoperative hypoparathyroidism.
The goal of this multicentric study is to demonstrate that the preservation of the function of parathyroid glands is greater with use of arteriography than without.
Read more
Patients will be divided in two groups. In the study group, the vascular map with ICG of parathyroid glands will be showed before performing the lobectomy. Once the lobectomy is done, the function of the glands will be assessed. Whereas in the control group, arteriography with ICG will only be carried out in order to check their function at the end of the lobectomy.
Researchers will compare the study group and the control group to see which one present the lowest taxes of postoperative hypoparathyroidism.
Read the detailed description
To assess the appearance of postoperative hypoparathyroidism, a systematic determination of PTH and corrected calcium values will be carried out the morning after the intervention.
It will be considered that there is hypoparathyroidism when the patient presents symptoms of hypocalcaemia, when he has required the administration of calcium and/or vitamin D prior to this determination or when he presents corrected calcium values < 1.8 mmol/L.
- Conditions
- Iatrogenic Hypocalcemia
- Being tested
- ICG angiography to show vascular map of parathyroid glands
- Keywords
- hypocalcemia, ICG angiography, Guided thyroidectomy
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG angiography to show vascular map of parathyroid glandsProcedure or surgery
Using ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then perform the thyroidectomy. After it, ICG angiography is done to predict immediate parathyroid functio
| Study group | Role | What they receive |
|---|---|---|
| Angiography group | Experimental | Patients undergoing initially ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then, post-thyroidectomy ICG angiography to predict immediate parathyroid function. Receives: Procedure: ICG angiography to show vascular map of parathyroid glands |
| Control group | No intervention | Patients who underwent post-thyroidectomy ICG angiography to predict immediate parathyroid gland function by scoring the degree of fluorescence of the parathyroid glands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants with postoperative permanent hypoparathyroidism
Comparison of postoperative permanent hypoparathyroidism between the two groups. It is considered permanent hypoparathyroidism in the presence of symptoms of hypocalcemia or less than 1.8mmol/L of calcium in asymptomatic patients during more than 12 months.
Measured: 1 year
Secondary outcomes (2)
Rate of participants with severe permanent hypocalcemia
Comparison of the occurrence of severe permanent hypocalcemia after total thyroidectomy between the two groups. Severe hypocalcemia is considered when vitamin D is added to the treatment with calcium. Permanent hypocalcemia is defined when it lasts more than 12 months.
Measured: 1 year
Number of parathyroid glands identified and preserved
Comparison of the number of parathyroid glands identified, left in situ and with an ICG score of 2 after total thyroidectomy between the two groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start11 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Iatrogenic HypocalcemiaStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Moreno Llorente, Hospital Universitari de Bellvitge
- Investigators
- Pablo Moreno, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573828
- Sponsor's protocol ID
- PR161/21
- Acronym
- GuiArte
- Status last verified
- Mar 2025
- First submitted
- 6 Oct 2022
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.
PubMed 24402815Vidal Fortuny J, Sadowski SM, Belfontali V, Karenovics W, Guigard S, Triponez F. Indocyanine Green Angiography in Subtotal Parathyroidectomy: Technique for the Function of the Parathyroid Remnant. J Am Coll Surg. 2016 Nov;223(5):e43-e49. doi: 10.1016/j.jamcollsurg.2016.08.540. Epub 2016 Aug 24. No abstract available.
PubMed 27568330Falco J, Dip F, Quadri P, de la Fuente M, Prunello M, Rosenthal RJ. Increased identification of parathyroid glands using near infrared light during thyroid and parathyroid surgery. Surg Endosc. 2017 Sep;31(9):3737-3742. doi: 10.1007/s00464-017-5424-1. Epub 2017 Mar 31.
PubMed 28364157Benmiloud F, Penaranda G, Chiche L, Rebaudet S. Intraoperative Mapping Angiograms of the Parathyroid Glands Using Indocyanine Green During Thyroid Surgery: Results of the Fluogreen Study. World J Surg. 2022 Feb;46(2):416-424. doi: 10.1007/s00268-021-06353-4. Epub 2021 Nov 6.
PubMed 34743241Llorente PM, Francos Martinez JM, Barrasa AG. Intraoperative Parathyroid Hormone Measurement vs Indocyanine Green Angiography of Parathyroid Glands in Prediction of Early Postthyroidectomy Hypocalcemia. JAMA Surg. 2020 Jan 1;155(1):84-85. doi: 10.1001/jamasurg.2019.3652.
PubMed 31617879Moreno-Llorente P, Garcia-Barrasa A, Pascua-Sole M, Videla S, Otero A, Munoz-de Nova JL. Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. World J Surg. 2023 Feb;47(2):421-428. doi: 10.1007/s00268-022-06683-x. Epub 2022 Aug 9.
PubMed 35945357Moreno-Llorente P, Garcia-Gonzalez G, Pascua-Sole M, Garcia-Barrasa A, Videla S, Munoz-de-Nova JL; GuiArte Study Group. Indocyanine green angiography-guided thyroidectomy versus conventional thyroidectomy for preserving parathyroid function: study protocol for a randomized single-blind controlled trial. Front Endocrinol (Lausanne). 2023 May 8;14:1193900. doi: 10.3389/fendo.2023.1193900. eCollection 2023.
PubMed 37223015
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. GuiArte Multicentric Randomized Study.
- ClinicalTrials.gov ID
- NCT05573828
- Acronym / sponsor ID
- GuiArte / PR161/21
- Conditions
- Iatrogenic Hypocalcemia
- Keywords
- hypocalcemia, ICG angiography, Guided thyroidectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Oct 2022 (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.
Transient and/or permanent hypoparathyroidism is the most frequent complication after total thyroidectomy. The identification of the parathyroid glands and a correct dissection during thyroidectomy have been postulated as key factors for their preservation and, consequently, to prevent hypoparathyroidism. The use of indocyanine green (ICG) fluorescence has reliably predicted parathyroid glands functionality in the immediate postoperative period. Recently, it is proposed that showing the vascular map of the parathyroid glands before performing the thyroidectomy by means of ICG angiography prevent the development of postoperative hypoparathyroidism.
The goal of this multicentric study is to demonstrate that the preservation of the function of parathyroid glands is greater with use of arteriography than without.
Patients will be divided in two groups. In the study group, the vascular map with ICG of parathyroid glands will be showed before performing the lobectomy. Once the lobectomy is done, the function of the glands will be assessed. Whereas in the control group, arteriography with ICG will only be carried out in order to check their function at the end of the lobectomy.
Researchers will compare the study group and the control group to see which one present the lowest taxes of postoperative hypoparathyroidism.
Detailed description
To assess the appearance of postoperative hypoparathyroidism, a systematic determination of PTH and corrected calcium values will be carried out the morning after the intervention.
It will be considered that there is hypoparathyroidism when the patient presents symptoms of hypocalcaemia, when he has required the administration of calcium and/or vitamin D prior to this determination or when he presents corrected calcium values < 1.8 mmol/L.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiography group | Experimental | Procedure: ICG angiography to show vascular map of parathyroid glandsPatients undergoing initially ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then, post-thyroidectomy ICG angiography to predict immediate parathyroid function. |
| Control group | No intervention | –Patients who underwent post-thyroidectomy ICG angiography to predict immediate parathyroid gland function by scoring the degree of fluorescence of the parathyroid glands |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18 years of age with a surgical indication for total thyroidectomy with or without central cervical lymph node dissection due to thyroid pathology.
- The patient or their guardian, where applicable, has the capacity to understand the study and agrees to participate in it, signing the corresponding informed consent document.
Key exclusion criteria (5 listed)
- Previous surgical intervention on the thyroid or parathyroid gland.
- Associated hyperparathyroidism that requires associating a parathyroidectomy in the same surgical act.
- Patients with contraindications for the administration of ICG.
- Current drug use or alcohol abuse that could interfere with compliance with the study requirements.
- Participation in any other drug trials in the month prior to randomization.
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 |
|---|---|---|
| ICG angiography to show vascular map of parathyroid glandsUsing ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then perform the thyroidectomy. After it, ICG angiography is done to predict immediate parathyroid functio | Procedure or surgery | Angiography group |
Primary outcome
Rate of participants with postoperative permanent hypoparathyroidism
Time frame: 1 year
Comparison of postoperative permanent hypoparathyroidism between the two groups. It is considered permanent hypoparathyroidism in the presence of symptoms of hypocalcemia or less than 1.8mmol/L of calcium in asymptomatic patients during more than 12 months.
2 secondary outcomes
Rate of participants with severe permanent hypocalcemia
Time frame: 1 year
Number of parathyroid glands identified and preserved
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 24402815Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.
- Background: PubMed 27568330Vidal Fortuny J, Sadowski SM, Belfontali V, Karenovics W, Guigard S, Triponez F. Indocyanine Green Angiography in Subtotal Parathyroidectomy: Technique for the Function of the Parathyroid Remnant. J Am Coll Surg. 2016 Nov;223(5):e43-e49. doi: 10.1016/j.jamcollsurg.2016.08.540. Epub 2016 Aug 24. No abstract available.
- Background: PubMed 28364157Falco J, Dip F, Quadri P, de la Fuente M, Prunello M, Rosenthal RJ. Increased identification of parathyroid glands using near infrared light during thyroid and parathyroid surgery. Surg Endosc. 2017 Sep;31(9):3737-3742. doi: 10.1007/s00464-017-5424-1. Epub 2017 Mar 31.
- Background: PubMed 34743241Benmiloud F, Penaranda G, Chiche L, Rebaudet S. Intraoperative Mapping Angiograms of the Parathyroid Glands Using Indocyanine Green During Thyroid Surgery: Results of the Fluogreen Study. World J Surg. 2022 Feb;46(2):416-424. doi: 10.1007/s00268-021-06353-4. Epub 2021 Nov 6.
- Background: PubMed 31617879Llorente PM, Francos Martinez JM, Barrasa AG. Intraoperative Parathyroid Hormone Measurement vs Indocyanine Green Angiography of Parathyroid Glands in Prediction of Early Postthyroidectomy Hypocalcemia. JAMA Surg. 2020 Jan 1;155(1):84-85. doi: 10.1001/jamasurg.2019.3652.
- Results publication: PubMed 35945357Moreno-Llorente P, Garcia-Barrasa A, Pascua-Sole M, Videla S, Otero A, Munoz-de Nova JL. Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. World J Surg. 2023 Feb;47(2):421-428. doi: 10.1007/s00268-022-06683-x. Epub 2022 Aug 9.
- Derived from this study: PubMed 37223015Moreno-Llorente P, Garcia-Gonzalez G, Pascua-Sole M, Garcia-Barrasa A, Videla S, Munoz-de-Nova JL; GuiArte Study Group. Indocyanine green angiography-guided thyroidectomy versus conventional thyroidectomy for preserving parathyroid function: study protocol for a randomized single-blind controlled trial. Front Endocrinol (Lausanne). 2023 May 8;14:1193900. doi: 10.3389/fendo.2023.1193900. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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.
Pablo Moreno principal investigator
Hospital Universitari de Bellvitge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG angiography to show vascular map of parathyroid glands in people with Iatrogenic Hypocalcemia, run by Hospital Universitari de Bellvitge at 2 sites in Spain.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pablo Moreno (661214772, 25108pml@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants with postoperative permanent hypoparathyroidism (time frame: 1 year). 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 NCT05573828, which also lists 7 linked publications.
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 19 Mar 2025.