Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery

Not Applicable

• Conditions: Hypocalcemia; Hypoparathyroidism Postprocedural; Surgery--Complications
• Interventions: Device: NIR optical imaging camera

• Registration Number: NCT04193332
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-08-16
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-14
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plus NIR optical imaging	NIR optical imaging camera	NIR optical imaging assisted identification of parathyroid glands during thyroid surgery

Primary Outcome Measures

Name	Time	Method
Postoperative hypoparathyroidism	24 months-follow-up	Hypoparathyroidism defined as: PTH \< 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline

Secondary Outcome Measures

Name	Time	Method
Time	Immediately after surgery	Duration of surgery
Parathyroidglands identified by NIR light	During surgery	Number of identified by NIR light vs. white light
Postoperative hypocalcemia	12 months follow-up	Hypocalcemia defined as: ionized Calcium \< 1,15 mmol/L

Trial Locations

Locations (2)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark; 🇩🇰 Køge, Denmark