Clinical trial NCT02892253: Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia
Official title: Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypocalcemia
Keywords: postoperative hypocalcemia
near infrared imaging
parathyroid autofluorescence
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This Multicenter, 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 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 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.

Eligibility criteria: Inclusion Criteria:

* All patients eligible for 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 autotransplanted parathyroids
timeFrame: immediate (intraoperative)
measure: Number of inadvertently resected parathyroids
timeFrame: delayed (10 days)
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Europeen
city: Marseille
country: France
facility: Hôpital Saint Joseph Marseille
city: Paris
country: France
facility: Hopital La Pitie Salpetriere
Study officials:
affiliation: Hopital Europeen de Marseille
name: BENMILOUD Fares, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Europeen de Marseille
name: BIDAUT Wahiba, Senior CRA
role: STUDY_CHAIR
affiliation: Hopital Europeen de Marseille
name: REBAUDET Stanislas, MD
role: STUDY_CHAIR
affiliation: Laboratoire Alphabio
name: PENARANDA Guillaume
role: STUDY_CHAIR
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.
citation: Benmiloud F, Godiris-Petit G, Gras R, Gillot JC, Turrin N, Penaranda G, Noullet S, Chereau N, Gaudart J, Chiche L, Rebaudet S. Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial. JAMA Surg. 2020 Feb 1;155(2):106-112. doi: 10.1001/jamasurg.2019.4613.