Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia

Not Applicable

Completed

• Conditions: Hypocalcemia
• Interventions: Device: Near Infrared Camera (NIR)

• Registration Number: NCT02892253
• Lead Sponsor: Hôpital Européen Marseille

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-08
• Primary Completion: 2018-06
• Study Completion: 2018-12-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postoperative hypocalcemia	6 months	Postoperative day 1 and day 2 corrected calcemia (hypocalcemia when calcemia \<2mmol/l). If hypocalcemia, calcium is measured at 1 month and 6 months

Secondary Outcome Measures

Name	Time	Method
Number of identified parathyroids	immediate (intraoperative)	identified by naked eye
Number of autotransplanted parathyroids	immediate (intraoperative)	when parathyroids cannot be left in situ, they are fragmented and reinserted in a sterno-cleido-mastoid muscle
Number of inadvertently resected parathyroids	delayed (10 days)	when parathyroid tissue is found on thyroid specimen (reported on pathology report)

Trial Locations

Locations (3)

Hopital La Pitie Salpetriere; 🇫🇷 Paris, France

Hopital Europeen; 🇫🇷 Marseille, France

Hôpital Saint Joseph Marseille; 🇫🇷 Marseille, France