Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

Hôpital Européen Marseille

Status: Completed

Conditions: Hypocalcemia

Treatments: Device: Near infrared camera (NIR)

Study type: Observational

Funder types: Other

Identifiers

NCT02889952

ParaFluo1

Details and patient eligibility

About

This Before-and-after Controlled Study study evaluates the clinical impact of parathyroid autofluorescence visualization using near infrared light (NIR) during total thyroidectomy (TT).

It compares two groups of consecutive patients who underwent TT associated or not to lymph node dissection (LND) with and without intraoperative use of NIR, by the same surgeon.

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 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.

The investigators compare 2 groups of patients operated by one surgeon during 2 consecutive but distinct periods (before and after the use of NIR) with control groups operated by another surgeon during the same periods. This study is observational since there was no predefined protocol nor sample size calculation of study groups prior to data collection.

Enrollment: 297 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who underwent 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

297 participants in 4 patient groups

NIR-

Description:

All consecutive patients (n=174) who underwent conventional total thyroidectomy (TT)+/- lymph node dissection (LND) without the use of NIR - parathyroid identification was done by naked eye only- by surgeon 1, from January 2015 to January 2016 (period 1)

NIR

Description:

All consecutive patients (n=63) who underwent conventional total thyroidectomy (TT)+/- lymph node dissection (LND) with intraoperative use of NIR - surgical field was examined with NIR before any thyroid dissection- by surgeon 1, from February 2016 to May 2016 (period 2)

Treatment:

Device: Near infrared camera (NIR)

Control1

Description:

Patients (n=30) patients randomly selected among the patients who underwent TT+/- LND without the use of NIR, by another surgeon in the unit (surgeon 2), during period 1.

Control2

Description:

Patients (n=30) patients randomly selected among the patients who underwent TT+/- LND without the use of NIR, by surgeon 2, during period 2.