Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

Completed

• Conditions: Hypocalcemia

• Registration Number: NCT02889952
• Lead Sponsor: Hôpital Européen Marseille

Brief Summary

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.

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 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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-05
• Status Verified: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-09-06
• Last Update Submitted: 2016-09-06
• Study First Posted: 2016-09-07
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 297

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)
number of autotransplantated parathyroids	immediate (intraoperative)	when parathyroids are impossible to preserve in situ, they are fragmented and inserted in the sternocleidomastoid muscle
number of inadvertently resected parathyroids	within 15 days after surgery (time to complete pathology examination)	When parathyroids are found on the thyroid specimen during pathology examination, they are called 'inadvertently resected'