Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia

Hôpital Européen Marseille

Status: Completed

Conditions: Hypocalcemia

Treatments: Device: Near Infrared Camera (NIR)

Study type: Interventional

Funder types: Other

Identifiers

NCT02892253

2016-A-000549-42ParaFluo2

Details and patient eligibility

About

This Multicenter, Randomized Controlled Trial evaluates the clinical impact of parathyroid autofluorescence visualization using near infrared light (NIR) during total thyroidectomy (TT). It compares patients who undergo TT associated or not with lymph node dissection (LND) with NIR vs without NIR use during surgery.

Full description

Total thyroidectomy (TT) is responsible for postoperative hypocalcemia in 20-30% of patients, which is definitive in 1-4% of operated patients (1). This complication is mainly due to surgery-induced parathyroid dysfunction, which could be improved by a better intraoperative identification of the parathyroids. Intraoperative parathyroid auto-fluorescence visualization (without any dye injection) using near infrared light (NIR) is an emerging technique, which allows correct identification of normal parathyroids in almost all cases (2), but the clinical impact of NIR is unknown.

The aim of this prospective, comparative randomized study, is to compare 2 groups of patients: patients operated with NIR (NIR+) vs patients operated without NIR (NIR-).

The main objective of this study is to assess the impact of intraoperative use of NIR camera on postoperative hypocalcemia. Secondary objectives are to assess the impact of NIR on the visualization, autotransplantation and inadvertent resection rates during TT.

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients eligible for one-stage total thyroidectomy, associated or not to lymph node dissection (TT +/- LND).

Exclusion criteria

• Combined parathyroid and thyroid disease (including patients with enlarged parathyroids incidentally found during surgery and resected)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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241 participants in 2 patient groups

NIR+ group

Experimental group

Description:

Patients who undergo conventional total thyroidectomy (TT)+/- lymph node dissection (LND). Parathyroid identification was done with the use of NIR (intervention group, NIR+ group)

Treatment:

Device: Near Infrared Camera (NIR)

NIR- group

No Intervention group

Description:

Patients who undergo conventional total thyroidectomy (TT)+/- lymph node dissection (LND) without the use of NIR - parathyroid identification was done by naked eye only (no intervention group, NIR- group)