Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
NCT ID: NCT04012476
Last Updated: 2019-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2016-11-30
2020-10-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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ICG
Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green
Indocyanine Green
Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light
Interventions
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Indocyanine Green
Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Universitat de les Illes Balears
OTHER
Hospital Son Espases
OTHER
Responsible Party
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Locations
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Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ICG-Parathyroid
Identifier Type: -
Identifier Source: org_study_id
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