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Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy

Sponsor
Onze Lieve Vrouw Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05117853
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
42.9
Anticipated Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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.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 :
Nov 1, 2021
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
May 31, 2025

Arms and Interventions

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 Names:
  • 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

    Primary Outcome Measures

    1. Postoperative hypocalcemia [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 [1 hour after surgery]

      Visual identification and confirmation with autofluorescence

    2. The number of reimplanted parathyroid glands [1 hour after surgery]

      Visual identification and decision to re-implant after ICG

    3. The presence of late or permanent hypocalcemia [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Onze Lieve Vrouw Hospital Aalst Belgium 9300

    Sponsors and Collaborators

    • Onze Lieve Vrouw Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Nov 11, 2021
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Hypocalcemia
    Hypoparathyroidism
    Thyroid Diseases
    Parathyroid Hormone

    Study Results

    No Results Posted as of Apr 21, 2022