Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography

NCT05328076 | Terminated FDA Drug FDA Device

• 1 other identifier: ANGIO PARA
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid; Thyroid Cancer; Hypoparathyroidism; Vascularization

Keywords

Parathyroid; Thyroid surgery; Indocyanine green angiography

Outcome Measures

Primary Outcomes (1)

• Vascularization score

  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.

  Intraoperatively

Study Arms (1)

Surgical group

Patients who undergo thyroid surgery and receive indocyanine green angiography

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

Interventions

Indocyanine green DRUG

Indocyanine green is used to perform intraoperative angiography.

Surgical group

SPY Portable Handheld Imaging (SPY-PHI) DEVICE

The device is used to perform intraoperative angiography.

Surgical group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients who need surgical treatment for thyroid disease.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (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.

  PMID: 27839936 BACKGROUND

• 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.

  PMID: 29405252 BACKGROUND

• 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.

  PMID: 31882459 BACKGROUND

• 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.

  PMID: 24563161 BACKGROUND

• 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.

  PMID: 27515510 BACKGROUND

• 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.

  PMID: 27041628 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases; Thyroid Neoplasms; Hypoparathyroidism; Neovascularization, Pathologic

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Parathyroid Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Riccardo Rosati, Prof.

  San Raffaele Hospiral

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: May 2, 2022
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)