Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography
NCT ID: NCT05328076
Last Updated: 2024-07-05
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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TERMINATED
22 participants
OBSERVATIONAL
2022-05-02
2023-01-19
Brief Summary
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The main objective of the study is to identify a quantitative score of parathyroid vascularization as an outcome of angiography that correlates with the absence of postoperative hypoparathyroidism.
It is planned to enroll 66 patients.
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Detailed Description
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Although the cause of postoperative hypoparathyroidism is multifactorial, one of the most important factors is vascularization of parathyroid glands left in situ that is insufficient or impaired by surgical manipulation. Therefore, one of the goals of thyroid surgery is not only to recognize the parathyroid glands during dissection but also to respect their vascularization in order to preserve well perfused and viable glands.
The general objective of this study is to quantitatively assess the vascularization of the parathyroids following total thyroid removal.
In particular, the investigators intend to obtain data regarding parathyroid vascularization during total thyroidectomy with indocyanine green angiography. During standard surgery, angiography will be performed using a special camera after having administered intravenously indocyanine green. This technique is used to objectively assess the degree of fluorescence of the parathyroid glands.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgical group
Patients who undergo thyroid surgery and receive indocyanine green angiography
Indocyanine green
Indocyanine green is used to perform intraoperative angiography.
SPY Portable Handheld Imaging (SPY-PHI)
The device is used to perform intraoperative angiography.
Interventions
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Indocyanine green
Indocyanine green is used to perform intraoperative angiography.
SPY Portable Handheld Imaging (SPY-PHI)
The device is used to perform intraoperative angiography.
Eligibility Criteria
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Inclusion Criteria
* Indication to total thyroidectomy
* No contraindication to indocyanine green administration
Exclusion Criteria
* Allergy to iodinated contrast
* Chronic kidney failure
* Pregnancy or lactation
18 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Riccardo Maggiore
Principal Investigator
Principal Investigators
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Riccardo Rosati, Prof.
Role: STUDY_DIRECTOR
San Raffaele Hospiral
Locations
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San Raffaele Hospital
Milan, , Italy
Countries
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References
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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.
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.
Spartalis E, Ntokos G, Georgiou K, Zografos G, Tsourouflis G, Dimitroulis D, Nikiteas NI. Intraoperative Indocyanine Green (ICG) Angiography for the Identification of the Parathyroid Glands: Current Evidence and Future Perspectives. In Vivo. 2020 Jan-Feb;34(1):23-32. doi: 10.21873/invivo.11741.
Puzziello A, Rosato L, Innaro N, Orlando G, Avenia N, Perigli G, Calo PG, De Palma M. Hypocalcemia following thyroid surgery: incidence and risk factors. A longitudinal multicenter study comprising 2,631 patients. Endocrine. 2014 Nov;47(2):537-42. doi: 10.1007/s12020-014-0209-y. Epub 2014 Feb 22.
Ji YB, Song CM, Sung ES, Jeong JH, Lee CB, Tae K. Postoperative Hypoparathyroidism and the Viability of the Parathyroid Glands During Thyroidectomy. Clin Exp Otorhinolaryngol. 2017 Sep;10(3):265-271. doi: 10.21053/ceo.2016.00724. Epub 2016 Aug 13.
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.
Other Identifiers
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ANGIO PARA
Identifier Type: -
Identifier Source: org_study_id
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