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Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy

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ClinicalTrials.gov Identifier: NCT05117853
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Klaas Van Den Heede, Onze Lieve Vrouw Hospital

Study Description
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Brief Summary:
  • Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy.
  • The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia.
  • Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery.
  • Injecting indocyanine green and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands.
  • This randomized clinical trial aims to investigate whether using autofluorescence and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia.

Condition or disease Intervention/treatment Phase
Thyroid Disease Hypoparathyroidism Postprocedural Drug: Autofluorescent detection + Injection of indocyanine green Procedure: Gold standard of visual identification and evaluation of viability of the parathyroid glands. Phase 3

Detailed Description:

Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy. When defined as corrected serum calcium levels below 2.10 mmol/L, the temporary rates of hypocalcemia after a total thyroidectomy excluding lymph node neck dissection still easily exceed 20% (BAETS fifth national audit report, 2017). When extending the follow-up period to more than six months after surgery, late or permanent hypocalcemia is seen in over 5% of patients after a total thyroidectomy. These British numbers have been confirmed in large European and American databases. A large, Belgian, single-center analysis, including redo-surgery and lymph node neck dissections, confirmed temporary and permanent rates of hypocalcemia of 32% and 3%, respectively.

While temporary hypocalcemia results in a reduced quality of life, additional medical costs to the patients and the society, and hypocalcemia-related symptoms, permanent hypocalcemia adds an increased risk of developing renal failure, basal ganglia calcifications, neuropsychiatric derangements, and infections.

The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia. The visual evaluation of parathyroid gland vascularization is even more challenging, prone to subjectivity, and depending on surgical experience and surgical volume. Moreover, even experienced endocrine surgeons appear to be unreliable in using visual scores to assess the viability of parathyroid glands.

Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery. However, this signal does not provide any information on viability and vascularization of the parathyroid glands. Injecting indocyanine green (ICG) and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands. The combined technique of autofluorescent and ICG-enhanced imaging suffers from lack of standardization, optimal technique, dosage, and timing of the ICG administration, and still must prove its possible benefit in a clinical setting.

Hence, this randomized clinical trial aims to investigate whether using autofluorescence (AF) and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia. By using parathyroid gland detection via autofluorescence imaging and verifying their viability after ICG injection, the authors aim to identify patients at risk of hypocalcemia.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center, comparative, randomized, single-blind, controlled trial against the gold standard of visual identification and viability evaluation.
Masking: Single (Participant)
Masking Description: Simple blind (Only participant)
Primary Purpose: Prevention
Official Title: The Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical Trial
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Autofluorescent detection and injection of indocyanine green

Drug: indocyanine green (ICG)

Autofluorescence detection of the parathyroid glands and injection of indocyanine green at two predefined timepoints will be performed to evaluate the vascularization of the parathyroid glands.

 Drug: Autofluorescent detection + Injection of indocyanine green

All four parathyroid glands will be actively sought for in every case selected for the use of AF/ICG, with AF verification of parathyroid tissue.

The timepoints of AF will be:

  • 1 = after lateral dissection side 1 (side 1)
  • 2= after lateral dissection side 2 (side 2)

The timepoints of ICG injection will be:

  • 1 = after the first thyroid lobectomy (side 1)
  • 2 = after the second thyroid lobectomy (side 2)

Scoring of the viability of parathyroid glands (adapted from Vidal Fortuny et al., 2016):

  • 1 = black = not viable/vascularized
  • 2 = grey = moderately viably/ moderately vascularized
  • 3 = white = viable/well-vascularized
Other Name: ICG Injection
Placebo Comparator: Control group
Gold standard of visual identification and evaluation of viability.
 Procedure: Gold standard of visual identification and evaluation of viability of the parathyroid glands.
Gold standard of visual identification and evaluation of viability of the parathyroid glands.


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative hypocalcemia [ Time Frame: One week after surgery ]
    Defined as parathyroid hormone (PTH) levels <15 pg/mL, serum calcium levels <2.10 mmol/L, or the intake of calcium or activated vitamin D supplements after total thyroidectomy.


Secondary Outcome Measures :
  1. The number of identified parathyroid glands [ Time Frame: 1 hour after surgery ]
    Visual identification and confirmation with autofluorescence

  2. The number of reimplanted parathyroid glands [ Time Frame: 1 hour after surgery ]
    Visual identification and decision to re-implant after ICG

  3. The presence of late or permanent hypocalcemia [ Time Frame: Six months after surgery ]
    Defined as persistent PTH levels <15 pg/mL, persistent serum calcium levels <2.10 mmol/L, or continued intake of calcium or activated vitamin D supplements more than six months after surgery.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients undergoing a total thyroidectomy without previous neck surgery.

Exclusion Criteria:

  • Children and teenagers (<18 years old)
  • Patients refusing participation or unable/unwilling to sign the informed consent
  • Patients with a completion thyroidectomy
  • Patients with planned central and lateral neck lymph node dissections (thyroid cancer)
  • Patients with previous neck surgery
  • Patients with a known allergy/hypersensitivity to indocyanine green
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): NCT05117853


Contacts
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Contact: Klaas Van Den Heede, MD 0032472893861 klaasvandenheede@hotmail.com
Contact: Sam Van Slycke, MD, PhD 003253724506 sam.van.slycke@olvz-aalst.be

Locations
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Belgium
Onze Lieve Vrouw Hospital Recruiting
Aalst, Belgium, 9300
Contact: Klaas Van Den Heede, MD    0032472893861    klaasvandenheede@hormail.com   
Contact: Sam Van Slycke, MD, PhD    003253724506    sam.van.slycke@olvz-aalst.be   
Sub-Investigator: Nele Brusselaers, MD, PhD         
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
More Information
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Publications:

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Responsible Party: Klaas Van Den Heede, Principal Investigator / Scientific Fellow, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT05117853    
Other Study ID Numbers: B1262021000021
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication.
Supporting Materials: Study Protocol
Time Frame: Data will be available from 1 year after till 20 years after final study completion.
Access Criteria: Data access request will be reviewed by the ethics committee of the Onze Lieve Vrouw Hospital, Aalst. Any request will require signing and completing a data access agreement.

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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
Additional relevant MeSH terms:
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Hypocalcemia
Hypoparathyroidism
Thyroid Diseases
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
 Metabolic Diseases
Water-Electrolyte Imbalance
Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs