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

February 6, 2023 updated by: Pablo Moreno Llorente, Hospital Universitari de Bellvitge

Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. GuiArte Multicentric Randomized Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

394

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Pablo Moreno Llorente
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital UIniversitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 11, 2022

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (ACTUAL)

October 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR161/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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