Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function (GuiArte)

• ClinicalTrials.gov Identifier: NCT05573828
• Recruitment Status: Recruiting
• First Posted: October 10, 2022
• Last Update Posted: February 8, 2023
• Sponsor: Hospital Universitari de Bellvitge
• Information provided by (Responsible Party): Pablo Moreno Llorente, Hospital Universitari de Bellvitge

Tracking Information

• First Submitted Date: October 6, 2022
• First Posted Date: October 10, 2022
• Last Update Posted Date: February 8, 2023
• Actual Study Start Date: October 11, 2022
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 2, 2023)

Rate of participants with postoperative permanent hypoparathyroidism [ Time Frame: 1 year ]

Comparison of postoperative permanent hypoparathyroidism between the two groups. It is considered permanent hypoparathyroidism in the presence of symptoms of hypocalcemia or less than 1.8mmol/L of calcium in asymptomatic patients during more than 12 months.

Original Primary Outcome Measures (submitted: October 6, 2022)

Hypocalcemia [ Time Frame: 1 year ]

Comparison of post-thyroidectomy hypocalcemia between the two groups. We consider hypocalcemia in the presence of symptoms of hypocalcemia or less than 1.8mmol/L in asymptomatic patients.

Current Secondary Outcome Measures (submitted: February 2, 2023)

• Rate of participants with severe permanent hypocalcemia [ Time Frame: 1 year ]
  Comparison of the occurrence of severe permanent hypocalcemia after total thyroidectomy between the two groups. Severe hypocalcemia is considered when vitamin D is added to the treatment with calcium. Permanent hypocalcemia is defined when it lasts more than 12 months.
• Number of parathyroid glands identified and preserved [ Time Frame: 1 year ]
  Comparison of the number of parathyroid glands identified, left in situ and with an ICG score of 2 after total thyroidectomy between the two groups.

Original Secondary Outcome Measures (submitted: October 6, 2022)

• Severe and permanent hypocalcemia [ Time Frame: 1 year ]
  Comparison of the occurrence of severe and permanent hypocalcemia after total thyroidectomy. We consider severe hypocalcemia when vitamin D is added to the treatment with calcium. We define permanent hypocalcemia when it lasts more than 12 months.
• Number of parathyroid glands [ Time Frame: 1 year ]
  Comparison of the number of parathyroid glands identified, left in situ and with an ICG score of 2 after total thyroidectomy. The outcomes are recorded with a number from 0 to 4 to each item.

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

Descriptive Information

• Brief Title: Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function
• Official Title: Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. GuiArte Multicentric Randomized Study.

Brief Summary

Transient and/or permanent hypoparathyroidism is the most frequent complication after total thyroidectomy. The identification of the parathyroid glands and a correct dissection during thyroidectomy have been postulated as key factors for their preservation and, consequently, to prevent hypoparathyroidism. The use of indocyanine green (ICG) fluorescence has reliably predicted parathyroid glands functionality in the immediate postoperative period. Recently, it is proposed that showing the vascular map of the parathyroid glands before performing the thyroidectomy by means of ICG angiography prevent the development of postoperative hypoparathyroidism.

The goal of this multicentric study is to demonstrate that the preservation of the function of parathyroid glands is greater with use of arteriography than without.

Patients will be divided in two groups. In the study group, the vascular map with ICG of parathyroid glands will be showed before performing the lobectomy. Once the lobectomy is done, the function of the glands will be assessed. Whereas in the control group, arteriography with ICG will only be carried out in order to check their function at the end of the lobectomy.

Researchers will compare the study group and the control group to see which one present the lowest taxes of postoperative hypoparathyroidism.

Detailed Description

To assess the appearance of postoperative hypoparathyroidism, a systematic determination of PTH and corrected calcium values will be carried out the morning after the intervention.

It will be considered that there is hypoparathyroidism when the patient presents symptoms of hypocalcaemia, when he has required the administration of calcium and/or vitamin D prior to this determination or when he presents corrected calcium values < 1.8 mmol/L.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Iatrogenic Hypocalcemia

Intervention

Procedure: ICG angiography to show vascular map of parathyroid glands

Using ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then perform the thyroidectomy. After it, ICG angiography is done to predict immediate parathyroid functio

Study Arms

• Experimental: Angiography group
  Patients undergoing initially ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then, post-thyroidectomy ICG angiography to predict immediate parathyroid function.
  Intervention: Procedure: ICG angiography to show vascular map of parathyroid glands
• No Intervention: Control group
  Patients who underwent post-thyroidectomy ICG angiography to predict immediate parathyroid gland function by scoring the degree of fluorescence of the parathyroid glands

Publications *

• Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.
• Vidal Fortuny J, Sadowski SM, Belfontali V, Karenovics W, Guigard S, Triponez F. Indocyanine Green Angiography in Subtotal Parathyroidectomy: Technique for the Function of the Parathyroid Remnant. J Am Coll Surg. 2016 Nov;223(5):e43-e49. doi: 10.1016/j.jamcollsurg.2016.08.540. Epub 2016 Aug 24. No abstract available.
• Falco J, Dip F, Quadri P, de la Fuente M, Prunello M, Rosenthal RJ. Increased identification of parathyroid glands using near infrared light during thyroid and parathyroid surgery. Surg Endosc. 2017 Sep;31(9):3737-3742. doi: 10.1007/s00464-017-5424-1. Epub 2017 Mar 31.
• Benmiloud F, Penaranda G, Chiche L, Rebaudet S. Intraoperative Mapping Angiograms of the Parathyroid Glands Using Indocyanine Green During Thyroid Surgery: Results of the Fluogreen Study. World J Surg. 2022 Feb;46(2):416-424. doi: 10.1007/s00268-021-06353-4. Epub 2021 Nov 6.
• Llorente PM, Francos Martinez JM, Barrasa AG. Intraoperative Parathyroid Hormone Measurement vs Indocyanine Green Angiography of Parathyroid Glands in Prediction of Early Postthyroidectomy Hypocalcemia. JAMA Surg. 2020 Jan 1;155(1):84-85. doi: 10.1001/jamasurg.2019.3652.
• Moreno-Llorente P, Garcia-Barrasa A, Pascua-Sole M, Videla S, Otero A, Munoz-de Nova JL. Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. World J Surg. 2023 Feb;47(2):421-428. doi: 10.1007/s00268-022-06683-x. Epub 2022 Aug 9.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 6, 2022): 394
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients ≥ 18 years of age with a surgical indication for total thyroidectomy with or without central cervical lymph node dissection due to thyroid pathology.
• The patient or their guardian, where applicable, has the capacity to understand the study and agrees to participate in it, signing the corresponding informed consent document.

Exclusion Criteria:

• Previous surgical intervention on the thyroid or parathyroid gland.
• Associated hyperparathyroidism that requires associating a parathyroidectomy in the same surgical act.
• Patients with contraindications for the administration of ICG.
• Current drug use or alcohol abuse that could interfere with compliance with the study requirements.
• Participation in any other drug trials in the month prior to randomization.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Pablo Moreno; 661214772; 25108pml@gmail.com

• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT05573828
• Other Study ID Numbers: PR161/21
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Pablo Moreno Llorente, Hospital Universitari de Bellvitge
• Original Responsible Party: Pablo Moreno Llorente, Hospital Universitari de Bellvitge, Ph
• Current Study Sponsor: Hospital Universitari de Bellvitge
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Pablo Moreno; Hospital Universitari de Bellvitge

• PRS Account: Hospital Universitari de Bellvitge
• Verification Date: February 2023