Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia

Sponsor

Hôpital Européen Marseille (Other)

Overall Status

Completed

CT.gov ID

NCT02892253

Collaborator

(none)

241

Enrollment

Locations

Arms

27.6

Actual Duration (Months)

80.3

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypocalcemia	Device: Near Infrared Camera (NIR)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

241 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Dec 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NIR+ group Patients who undergo conventional total thyroidectomy (TT)+/- lymph node dissection (LND). Parathyroid identification was done with the use of NIR (intervention group, NIR+ group)	Device: Near Infrared Camera (NIR) Surgical field is examined with NIR, during a few minutes (<5') with room lights switched off, to avoid parasite lights, then open thyroidectomy is resumed conventionally. Real-time images, evocative of autofluorescent parathyroids, are checked visually. NIR consists 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 standard IEC 60601-2-41). It is provided by the Fluobeam® camera, which is 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 2A device). Other Names: Fluobeam® system (Fluoptics®, Grenoble, France)
No Intervention: NIR- group Patients who undergo conventional total thyroidectomy (TT)+/- lymph node dissection (LND) without the use of NIR - parathyroid identification was done by naked eye only (no intervention group, NIR- group)

Arm

Intervention/Treatment

Experimental: NIR+ group

Patients who undergo conventional total thyroidectomy (TT)+/- lymph node dissection (LND). Parathyroid identification was done with the use of NIR (intervention group, NIR+ group)

Device: Near Infrared Camera (NIR)

Surgical field is examined with NIR, during a few minutes (<5') with room lights switched off, to avoid parasite lights, then open thyroidectomy is resumed conventionally. Real-time images, evocative of autofluorescent parathyroids, are checked visually. NIR consists 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 standard IEC 60601-2-41). It is provided by the Fluobeam® camera, which is 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 2A device).

Other Names:

Fluobeam® system (Fluoptics®, Grenoble, France)

No Intervention: NIR- group

Patients who undergo conventional total thyroidectomy (TT)+/- lymph node dissection (LND) without the use of NIR - parathyroid identification was done by naked eye only (no intervention group, NIR- group)

Outcome Measures

Primary Outcome Measures

Postoperative hypocalcemia [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hopital Europeen	Marseille	France	13003
2	Hôpital Saint Joseph Marseille	Marseille	France	13008
3	Hopital La Pitie Salpetriere	Paris	France	75013

Sponsors and Collaborators

Hôpital Européen Marseille

Investigators

Principal Investigator: BENMILOUD Fares, MD, Hopital Europeen de Marseille
Study Chair: BIDAUT Wahiba, Senior CRA, Hopital Europeen de Marseille
Study Chair: REBAUDET Stanislas, MD, Hopital Europeen de Marseille
Study Chair: PENARANDA Guillaume, Laboratoire Alphabio

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Fares BENMILOUD, MD, Hôpital Européen Marseille

ClinicalTrials.gov Identifier:

NCT02892253

Other Study ID Numbers:

2016-A-000549-42ParaFluo2

First Posted:

Sep 8, 2016

Last Update Posted:

Jan 7, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Fares BENMILOUD, MD, Hôpital Européen Marseille

postoperative hypocalcemia

near infrared imaging

parathyroid autofluorescence

Additional relevant MeSH terms:

Hypocalcemia

Study Results

No Results Posted as of Jan 7, 2019