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

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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Iatrogenic Hypocalcemia Procedure: ICG angiography to show vascular map of parathyroid glands Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. GuiArte Multicentric Randomized Study.
Actual Study Start Date : October 11, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05573828


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

Locations
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Spain
Pablo Moreno Llorente Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Pablo Moreno    661214772    25108pml@gmail.com   
Hospital UIniversitari de Bellvitge Recruiting
L'Hospitalet De Llobregat, Barcelona, Spain, 08907
Contact: Pablo Moreno    34 661214772    25108pml@gmail.com   
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
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Principal Investigator: Pablo Moreno Hospital Universitari de Bellvitge
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Pablo Moreno Llorente, Head of Endocrine Surgery, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT05573828    
Other Study ID Numbers: PR161/21
First Posted: October 10, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Pablo Moreno Llorente, Hospital Universitari de Bellvitge:
hypocalcemia
ICG angiography
Guided thyroidectomy
Additional relevant MeSH terms:
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Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
 Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs