Near-infrared Imaging Techniques for Identifying and Preserving Viable Parathyroid Glands During Thyroidectomy

NCT05130476 | Completed DMC

• 1 other identifier: S-20200154
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

The parathyroid glands and their blood vessels are notoriously difficult to visualize and may therefore be unintentionally and irrevocably damaged during thyroid surgery. This project investigates new surgeon-performed imaging techniques that visualize the parathyroid glands and their vessels in real-time during thyroid surgery. The purpose is to examine, in a matched cohort study, whether the implementation of near-infrared-induced autofluorescence for identification of the parathyroid glands, combined with indocyanine green near-infrared angiography of the parathyroid feeding vessels, can reduce the incidence of postoperative hypocalcaemia in patients undergoing total and completion thyroidectomy at Odense University Hospital.

Conditions

Hypoparathyroidism Postprocedural

Keywords

Near-infrared fluorescence

Outcome Measures

Primary Outcomes (1)

• Permanent hypoparathyroidism 12 months after surgery

  The number of participants in the study cohort with permanent hypoparathyroidism 12 months after treatment compared to the number of participants with permanent hypoparathyroidism 12 months after treatment in a matched retrospective cohort from the same hospital that underwent surgery without NIRAF+ICGA.

  12 months postoperatively

Study Arms (1)

NIRAF+ICGA

EXPERIMENTAL

During thyroid surgery, near-infrared-induced autofluorescence is used for the identification of the parathyroid glands, combined with indocyanine green near-infrared angiography for identification of the parathyroid feeding vessels.

Procedure: Near-infrared-induced autofluorescence and indocyanine green near-infrared angiography

Interventions

Near-infrared-induced autofluorescence and indocyanine green near-infrared angiography PROCEDURE

During thyroid surgery, near-infrared-induced autofluorescence is used for the identification of the parathyroid glands, combined with indocyanine green near-infrared angiography for identification of the parathyroid feeding vessels.

NIRAF+ICGA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years and older who are scheduled to undergo total or completion thyroidectomy at the department of Oro-Rhino-Laryngology (ORL) and Head and Neck Surgery at Odense University Hospital, Denmark.

You may not qualify if:

• Not legally competent.
• Does not read or speak Danish.
• Is pregnant or nursing.
• Suffers from chronic kidney disease with an estimated glomerular filtration rate \< 45 ml/min/1.73m2.
• Has a history of allergy to iodides or to indocyanine green.
• Suffers from hyperparathyroidism, hypoparathyroidism, or hypocalcaemia prior to surgery.
• Prescription use of supplemental active vitamin D: dihydrotachysterol (ATC 11CC02), alfacalcidol (ATC A11CC03), or calcitriol (ATC A11CC04).
• Patients scheduled to have a radioactive iodine uptake study performed ≤ 7 days after the thyroidectomy.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Matched cohort study

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 23, 2021
• Study Start: October 1, 2021
• Primary Completion: October 13, 2023
• Study Completion: November 20, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)