Clinical Trial: Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Parathyroid Autofluorescence Visualization During Thyroid Surgery: Impact on Postoperative Hypocalcemia

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 Summary:

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.


Sponsor: Hôpital Européen Marseille

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • number of identified parathyroids [ Time Frame: immediate (intraoperative) ]
  • 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
  • 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'


Original Secondary Outcome: Same as current

Information By: Hôpital Européen Marseille

Dates:
Date Received: August 29, 2016
Date Started: January 2015
Date Completion:
Last Updated: September 6, 2016
Last Verified: August 2016