Hypocalcemia
Conditions
Keywords
postoperative hypocalcemia, near infrared imaging, parathyroid autofluorescence
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.
Interventions
Surgical field was examined with NIR, during a few minutes (\<5') with room lights switched off, to avoid parasite lights, then conventional open thyroidectomy was resumed conventionally. Real-time images, evocative of autofluorescent parathyroids, were checked visually. NIR consisted of a 750 nm class 1 laser excitation, with a power \<20mW/cm2 (5 times less than the limit of 100mw/cm2, fixed by the international norm IEC 60601-2-41). It was provided by the Fluobeam® camera, which was inserted into a sterile cover and hold at a 15-20 cm distance from the patient. The system has an FDA 510(k) authorization for clinical use in parathyroid surgery and a European Community certification (Class 1 device).
Sponsors
Assistance Publique Hopitaux De Marseille
Hôpital Européen Marseille
Study design
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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' |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of parathyroids identified by NIR before naked eye | immediate (intraoperative) | in NIR group only |
Outcome results
None listed