Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery

Rigshospitalet

Status: Unknown

Conditions: Hypoparathyroidism Postprocedural; Surgery--Complications; Hypocalcemia

Treatments: Device: NIR optical imaging camera

Study type: Interventional

Funder types: Other

Identifiers

NCT04193332

H19010211

Details and patient eligibility

About

The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.

Full description

Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to:

1. Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence.
2. Control: Conventional thyroidectomy and parathyroid identification by the surgeon.

Measurements:

PTH and ionized-Ca blood samples are collected preoperatively, within 12 hours postoperatively and at 1-, 3-, 9- and 12-months follow-up.

Anticipated 214 patients are included, all of which participate in 3 months follow-up. Only patients with persistent hypoparathyroidism at this point continue til maximum 12 months follow-up.

An interim analysis will be conducted when inclusion of anticipated 128 patients and 3 months follow-up is reached.

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand patient information and to give written informed consent
• Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.

Exclusion criteria

• Not able to understand patient information and to give written informed consent
• Previous parathyroid surgery or other parathyroid decease
• Age under 18

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 2 patient groups

Plus NIR optical imaging

Experimental group

Description:

NIR optical imaging assisted identification of parathyroid glands during thyroid surgery

Treatment:

Device: NIR optical imaging camera

Minus NIR optical imaging

No Intervention group

Description:

Conventional identification of parathyroid glands during thyroid surgery