Clinical trial NCT02889952: Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery
Official title: Parathyroid Autofluorescence Visualization During Thyroid Surgery: Impact on Postoperative Hypocalcemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypocalcemia
Keywords: postoperative hypocalcemia
near infrared imaging
parathyroid autofluorescence
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
Collaborators: name: Assistance Publique Hopitaux De Marseille
First posted: 2016-09-07
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who underwent one-stage total thyroidectomy, associated or not to lymph node dissection (TT +/- LND) in the European Hospital Marseilles were consecutively included in this study, from January 2015 to May 2016.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Postoperative hypocalcemia
timeFrame: 6 months
Secondary outcomes:
measure: number of identified parathyroids
timeFrame: immediate (intraoperative)
measure: number of autotransplantated parathyroids
timeFrame: immediate (intraoperative)
measure: number of inadvertently resected parathyroids
timeFrame: within 15 days after surgery (time to complete pathology examination)
Other outcomes:
measure: number of parathyroids identified by NIR before naked eye
timeFrame: immediate (intraoperative)
Locations:
Study officials:
affiliation: Hopital Europeen Marseille
name: Fares BENMILOUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duclos A, Peix JL, Colin C, Kraimps JL, Menegaux F, Pattou F, Sebag F, Touzet S, Bourdy S, Voirin N, Lifante JC; CATHY Study Group. Influence of experience on performance of individual surgeons in thyroid surgery: prospective cross sectional multicentre study. BMJ. 2012 Jan 10;344:d8041. doi: 10.1136/bmj.d8041.
citation: McWade MA, Sanders ME, Broome JT, Solorzano CC, Mahadevan-Jansen A. Establishing the clinical utility of autofluorescence spectroscopy for parathyroid detection. Surgery. 2016 Jan;159(1):193-202. doi: 10.1016/j.surg.2015.06.047. Epub 2015 Oct 9.