Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia

January 4, 2019 updated by: Fares BENMILOUD, Hôpital Européen Marseille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

241

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13003
        • Hôpital Européen
      • Marseille, France, 13008
        • Hôpital Saint Joseph Marseille
      • Paris, France, 75013
        • Hôpital La Pitié Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of identified parathyroids
Time Frame: immediate (intraoperative)
identified by naked eye
immediate (intraoperative)
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
immediate (intraoperative)
Number of inadvertently resected parathyroids
Time Frame: delayed (10 days)
when parathyroid tissue is found on thyroid specimen (reported on pathology report)
delayed (10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Européen Marseille

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A-000549-42ParaFluo2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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