Clinical trial

The Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical Trial

Name

B1262021000021

Description

* 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.

Trial arms

Trial start

2021-11-01

Estimated PCD

2024-10-31

Trial end

2025-05-31

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Autofluorescent detection and injection of indocyanine green

Other names:

ICG Injection

Gold standard of visual identification and evaluation of viability of the parathyroid glands.

Arms:

Control group

Size

300

Primary endpoint

Postoperative hypocalcemia

One week after surgery

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, comparative, randomized, single-blind, controlled trial against the gold standard of visual identification and viability evaluation.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Simple blind (Only participant)', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

Updated at

2024-04-05

1 organization

1 product

2 indications

Organization

Onze Lieve Vrouw Hospital

Product

Indocyanine Green

Indication

Thyroid Disorder

Indication

Hypoparathyroidism Postprocedural