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

July 3, 2024 updated by: Riccardo Maggiore, IRCCS San Raffaele

Analysis of Parathyroid Vascularization During Total Thyroidectomy Using Quantitative Real-time Indocyanine Green Angiography

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

22

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

  • Italy
      • Milan, Italy, 20132
        • San Raffaele Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Inpatients who need surgical treatment for thyroid disease.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical group
Patients who undergo thyroid surgery and receive indocyanine green angiography
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperatively

Collaborators and Investigators

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

Sponsor

IRCCS San Raffaele

Investigators

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

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)

May 2, 2022

Primary Completion (Actual)

January 19, 2023

Study Completion (Actual)

January 19, 2023

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANGIO PARA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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