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HypocalcemiaPhase 4NCT04012476

Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy

A Phase 4 study testing Indocyanine Green in people with Hypocalcemia and Total Thyroidectomy, run by Hospital Son Espases at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Indocyanine Green
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
Nov 2016to Oct 2020
Phase
Phase 4
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

Who may be able to join

  • Patients who are going to undergo total thyroidectomy, with or without cervical lymph node dissection.
  • Visualization of 2 or more parathyroid glands during the surgical act.
  • Normal renal and hepatic functions.
  • Absence of a history of hypersensitivity reactions to iodine or indocyanine green.
  • Able to understand the nature and protocol of the study and its procedures
  • Willingness to participate with the subsequent signing of informed consent.

Who cannot join

  • Age <18 years
  • Hepatic or renal insufficiency
  • Hypersensitivity to iodine or to indocyanine green.
  • Pregnancy or lactation
  • Inability to understand the nature and procedures of the study.
  • Patients with known preoperative hyperparathyroidism.

Trial locations and contacts

1 site in 1 country.

Jaime Bonnín Pascual, MD contact

871205959

jaime.bonnin@ssib.es

Spain1 site, 1 recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca, Balearic Islands, 07120

    Jaime Bonnín Pascual, MD, 871205959, jaime.bonnin@ssib.es

    Recruiting

Other trials in Spain

About this study

The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia.

Read the detailed description

The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it. Therefore, the following points will be studied:

  • To study the correlation between parathyroid vascularization (intraoperative fluorescence intensity) and postoperative glandular function (serum calcium and parathormone levels).
  • To compare the surgeon's subjective assessment of parathyroid fluorescence in the groups of patients with and without postoperative hypocalcemia.
  • To compare the objective assessment of parathyroid fluorescence, by using specific computer software developed ad hoc, in the groups of patients with and without postoperative hypocalcemia.
Being tested
Indocyanine Green
Keywords
Hypocalcemia post-thyroidectomy, Indocyanine green, Fluorescence guided surgery, Parathyroid fluorescence
Medical subject headings
Hypocalcemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine GreenDrug

    Also called ICG

    Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light

Study groups in NCT04012476
Study groupRoleWhat they receive
ICGExperimentalPatients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green
Receives: Drug: Indocyanine Green

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Calcemia

    Serum calcium level at 24 hours postoperatively

    Measured: Day 1 after surgery

  2. Subjective parathyroid fluorescence

    Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured on a subjective analogue scale (0: no fluorescence, 1: hypofluorescence or heterogeneous fluorescence, 2: homogeneous hyperfluorescence).

    Measured: Intraoperatively

  3. Objective parathyroid fluorescence

    Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc.

    Measured: Intraoperatively

Secondary outcomes (19)

  1. Age

    Patient's age

    Measured: Baseline

  2. Sex

    Patient's gender

    Measured: Baseline

  3. Body mass index

    Patient's BMI

    Measured: Baseline

  4. Surgery date

    Day when surgery takes place

    Measured: Baseline

  5. Preoperative diagnosis

    Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis)

    Measured: Baseline

  6. Vitamin D

    Preoperative vitamin D level

    Measured: Preoperative blood test

  7. PTH preop

    Preoperative PTH level

    Measured: Immediately before surgery

  8. PTH 10 min

    PTH levels 10 minutes post-thyroidectomy

    Measured: 10 minutes post-thyroidectomy

  9. Surgery

    Scope of surgery: total thyroidectomy (TT), TT with central neck dissection, or TT with functional lateral neck dissection

    Measured: Inmediately after surgery

  10. Time

    Duration of surgery

    Measured: Inmediately after surgery

  11. Parathyroid glands

    Number of parathyroid glands located during surgery,

    Measured: During surgery

  12. Parathyroid gland location

    Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left).

    Measured: During surgery

  13. Pathologic result

    Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis)

    Measured: during the first month after surgery

  14. Thyroid weight

    Thyroid weight

    Measured: during the first month after surgery

  15. PG in piece

    Presence of parathyroid glands in the surgical piece and number

    Measured: during the first month after surgery

  16. Stay

    Number of days of postoperative hospital stay until the day of hospital discharge, measured as full days of 24 hours

    Measured: During the first month after surgery

  17. Drain

    Presence and number of surgical drainages

    Measured: Inmediately after surgery

  18. PTH day 1

    PTH levels in the postoperative follow-up,

    Measured: Day 1 after surgery

  19. Complications

    Emergence of postoperative complications.

    Measured: During the first month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2019
  2. Study startNov 2016
  3. Primary completionMar 2020 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

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 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Single group: patients undergoing total thyroidectomy with intraoperative infusion of intravenous indocyanine green A prospective unicentric and open clinical trial in which the fluorescence intensity of the parathyroid glands after indocyanine administration will be compared between two groups of patients: those with post-thyroidectomy hypocalcemia and patients who do not present it.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04012476
Sponsor's protocol ID
ICG-Parathyroid
Status last verified
Jul 2019
First submitted
28 Jun 2019
Last updated
9 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vidal Fortuny J, Belfontali V, Sadowski SM, Karenovics W, Guigard S, Triponez F. Parathyroid gland angiography with indocyanine green fluorescence to predict parathyroid function after thyroid surgery. Br J Surg. 2016 Apr;103(5):537-43. doi: 10.1002/bjs.10101. Epub 2016 Feb 11.

    PubMed 26864909

  • 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

  • Lang BH, Wong CK, Hung HT, Wong KP, Mak KL, Au KB. Indocyanine green fluorescence angiography for quantitative evaluation of in situ parathyroid gland perfusion and function after total thyroidectomy. Surgery. 2017 Jan;161(1):87-95. doi: 10.1016/j.surg.2016.03.037. Epub 2016 Nov 10.

    PubMed 27839936

  • Zaidi N, Bucak E, Yazici P, Soundararajan S, Okoh A, Yigitbas H, Dural C, Berber E. The feasibility of indocyanine green fluorescence imaging for identifying and assessing the perfusion of parathyroid glands during total thyroidectomy. J Surg Oncol. 2016 Jun;113(7):775-8. doi: 10.1002/jso.24237. Epub 2016 Apr 4.

    PubMed 27041628

  • Galvez-Pastor S, Torregrosa NM, Rios A, Febrero B, Gonzalez-Costea R, Garcia-Lopez MA, Balsalobre MD, Pastor-Perez P, Moreno P, Vazquez-Rojas JL, Rodriguez JM. Prediction of hypocalcemia after total thyroidectomy using indocyanine green angiography of parathyroid glands: A simple quantitative scoring system. Am J Surg. 2019 Nov;218(5):993-999. doi: 10.1016/j.amjsurg.2018.12.074. Epub 2019 Jan 4.

    PubMed 30665612

  • Rudin AV, McKenzie TJ, Thompson GB, Farley DR, Lyden ML. Evaluation of Parathyroid Glands with Indocyanine Green Fluorescence Angiography After Thyroidectomy. World J Surg. 2019 Jun;43(6):1538-1543. doi: 10.1007/s00268-019-04909-z.

    PubMed 30659346

  • Bonnin-Pascual J, Alvarez-Segurado C, Jimenez-Segovia M, Bianchi A, Bonnin-Pascual F, Molina-Romero FX, Gonzalez-Argente FX. Contributions of fluorescence to endocrine surgery. Cir Esp (Engl Ed). 2018 Nov;96(9):529-536. doi: 10.1016/j.ciresp.2018.09.005. Epub 2018 Oct 14. English, Spanish.

    PubMed 30327136

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Indocyanine Green in people with Hypocalcemia and Total Thyroidectomy, run by Hospital Son Espases at 1 site 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Jul 2019. 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 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jaime Bonnín Pascual, MD (871205959, jaime.bonnin@ssib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Calcemia (time frame: Day 1 after surgery). The study lists 3 primary outcomes in all. 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 NCT04012476, 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 9 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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