Clinical Trial: Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia. A Randomized Controlled Trial

Brief Summary: This 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 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 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.


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) ]
    identified by naked eye
  • Number of autotransplanted parathyroids [ Time Frame: 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 [ Time Frame: delayed (10 days) ]
    when parathyroid tissue is found on thyroid specimen (reported on pathology report)


Original Secondary Outcome:

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


Information By: Hôpital Européen Marseille

Dates:
Date Received: September 1, 2016
Date Started: September 2016
Date Completion: December 2017
Last Updated: November 15, 2016
Last Verified: November 2016