Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography (ANGIO_PARA)

• ClinicalTrials.gov Identifier: NCT05328076
• Recruitment Status: Active, not recruiting
• First Posted: April 14, 2022
• Last Update Posted: September 28, 2023
• Sponsor: IRCCS San Raffaele
• Information provided by (Responsible Party): Riccardo Maggiore, IRCCS San Raffaele

Tracking Information

• First Submitted Date: April 7, 2022
• First Posted Date: April 14, 2022
• Last Update Posted Date: September 28, 2023
• Actual Study Start Date: May 2, 2022
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 14, 2022)

Vascularization score [ Time Frame: Intraoperatively ]

A quantitative score of parathyroid vascularization as an outcome of indocyanine green angiography during thyroidectomy that correlates with the absence of postoperative hypoparathyroidism. The score will be reported as a percentage (range 0% - 200%) where the higher score means the better outcome.

Original Primary Outcome Measures (submitted: April 7, 2022)

Vascularization score [ Time Frame: Intraoperatively ]

A quantitative score of parathyroid vascularization as an outcome of ICG angiography during thyroidectomy that correlates with the absence of postoperative hypoparathyroidism.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography
• Official Title: Analysis of Parathyroid Vascularization During Total Thyroidectomy Using Quantitative Real-time Indocyanine Green Angiography

Brief Summary

Prospective, observational, single-center study about the use of indocyanine green angiography during total thyroidectomy.

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.

Detailed Description

Postoperative hypoparathyroidism and subsequent hypocalcemia are the most frequent complications after thyroid surgery. The incidence ranges from 19-38%, depending on the definition of hypoparathyroidism and hypocalcemia.

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Inpatients who need surgical treatment for thyroid disease.

Condition

• Thyroid
• Thyroid Cancer
• Hypoparathyroidism
• Vascularization

Intervention

• Drug: Indocyanine green
  Indocyanine green is used to perform intraoperative angiography.
• Device: SPY Portable Handheld Imaging (SPY-PHI)
  The device is used to perform intraoperative angiography.

Study Groups/Cohorts

Surgical group

Patients who undergo thyroid surgery and receive indocyanine green angiography

Interventions:

• Drug: Indocyanine green
• Device: SPY Portable Handheld Imaging (SPY-PHI)

Publications *

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: April 7, 2022): 66
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Able to sign informed consent
• Indication to total thyroidectomy
• No contraindication to indocyanine green administration

Exclusion Criteria:

• Evidence of parathyroid disease
• Allergy to iodinated contrast
• Chronic kidney failure
• Pregnancy or lactation

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT05328076
• Other Study ID Numbers: ANGIO PARA
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Riccardo Maggiore, IRCCS San Raffaele
• Original Responsible Party: Riccardo Maggiore, IRCCS San Raffaele, Dr.
• Current Study Sponsor: IRCCS San Raffaele
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Riccardo Rosati, Prof.; San Raffaele Hospiral

• PRS Account: IRCCS San Raffaele
• Verification Date: September 2023