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NCT Number: NCT02889952

Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

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.

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Key information

Conditions

Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Near infrared camera (NIR)

Device

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).

Other names: Fluobeam® system (Fluoptics®, Grenoble, France)

Primary outcomes

  1. Postoperative hypocalcemia

    Time frame: 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 outcomes

  1. number of identified parathyroids

    Time frame: immediate (intraoperative)

  2. number of autotransplantated parathyroids

    Time frame: immediate (intraoperative)

    when parathyroids are impossible to preserve in situ, they are fragmented and inserted in the sternocleidomastoid muscle

  3. number of inadvertently resected parathyroids

    Time frame: 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 outcomes

  1. number of parathyroids identified by NIR before naked eye

    Time frame: immediate (intraoperative)

    in NIR group only

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille

Other

Collaborators

  • Assistance Publique Hopitaux De Marseille

Registry information

Official study title

Parathyroid Autofluorescence Visualization During Thyroid Surgery: Impact on Postoperative Hypocalcemia

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 7, 2016
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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