Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy

July 7, 2019 updated by: Hospital Son Espases
The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it. Therefore, the following points will be studied:

  • To study the correlation between parathyroid vascularization (intraoperative fluorescence intensity) and postoperative glandular function (serum calcium and parathormone levels).
  • To compare the surgeon's subjective assessment of parathyroid fluorescence in the groups of patients with and without postoperative hypocalcemia.
  • To compare the objective assessment of parathyroid fluorescence, by using specific computer software developed ad hoc, in the groups of patients with and without postoperative hypocalcemia.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Spain
    • Illes Balears
      • Palma De Mallorca, Illes Balears, Spain, 07120
        • Recruiting
        • Hospital Universitari Son Espases
        • Contact:

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are going to undergo total thyroidectomy, with or without cervical lymph node dissection.
  • Visualization of 2 or more parathyroid glands during the surgical act.
  • Normal renal and hepatic functions.
  • Absence of a history of hypersensitivity reactions to iodine or indocyanine green.
  • Able to understand the nature and protocol of the study and its procedures
  • Willingness to participate with the subsequent signing of informed consent.

Exclusion Criteria:

  • Age <18 years
  • Hepatic or renal insufficiency
  • Hypersensitivity to iodine or to indocyanine green.
  • Pregnancy or lactation
  • Inability to understand the nature and procedures of the study.
  • Patients with known preoperative hyperparathyroidism.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG
Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green
Drug: Indocyanine Green
Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light
Other Names:
  • ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcemia
Time Frame: Day 1 after surgery
Serum calcium level at 24 hours postoperatively
Day 1 after surgery
Subjective parathyroid fluorescence
Time Frame: Intraoperatively
Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured on a subjective analogue scale (0: no fluorescence, 1: hypofluorescence or heterogeneous fluorescence, 2: homogeneous hyperfluorescence).
Intraoperatively
Objective parathyroid fluorescence
Time Frame: Intraoperatively
Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc.
Intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Baseline
Patient's age
Baseline
Sex
Time Frame: Baseline
Patient's gender
Baseline
Body mass index
Time Frame: Baseline
Patient's BMI
Baseline
Surgery date
Time Frame: Baseline
Day when surgery takes place
Baseline
Preoperative diagnosis
Time Frame: Baseline
Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis)
Baseline
Vitamin D
Time Frame: Preoperative blood test
Preoperative vitamin D level
Preoperative blood test
PTH preop
Time Frame: Immediately before surgery
Preoperative PTH level
Immediately before surgery
PTH 10 min
Time Frame: 10 minutes post-thyroidectomy
PTH levels 10 minutes post-thyroidectomy
10 minutes post-thyroidectomy
Surgery
Time Frame: Inmediately after surgery
Scope of surgery: total thyroidectomy (TT), TT with central neck dissection, or TT with functional lateral neck dissection
Inmediately after surgery
Time
Time Frame: Inmediately after surgery
Duration of surgery
Inmediately after surgery
Parathyroid glands
Time Frame: During surgery
Number of parathyroid glands located during surgery,
During surgery
Parathyroid gland location
Time Frame: During surgery
Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left).
During surgery
Pathologic result
Time Frame: during the first month after surgery
Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis)
during the first month after surgery
Thyroid weight
Time Frame: during the first month after surgery
Thyroid weight
during the first month after surgery
PG in piece
Time Frame: during the first month after surgery
Presence of parathyroid glands in the surgical piece and number
during the first month after surgery
Stay
Time Frame: During the first month after surgery
Number of days of postoperative hospital stay until the day of hospital discharge, measured as full days of 24 hours
During the first month after surgery
Drain
Time Frame: Inmediately after surgery
Presence and number of surgical drainages
Inmediately after surgery
PTH day 1
Time Frame: Day 1 after surgery
PTH levels in the postoperative follow-up,
Day 1 after surgery
Complications
Time Frame: During the first month after surgery
Emergence of postoperative complications.
During the first month after surgery

Collaborators and Investigators

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

Sponsor

Hospital Son Espases

Collaborators

Universitat de les Illes Balears

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)

November 1, 2016

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

July 7, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 7, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICG-Parathyroid

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

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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