Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

September 6, 2016 updated by: Fares BENMILOUD, Hôpital Européen Marseille

Parathyroid Autofluorescence Visualization During Thyroid Surgery: Impact on Postoperative Hypocalcemia

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.

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 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.

Study Type

Observational

Enrollment (Actual)

297

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

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

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NIR-
All consecutive patients (n=174) who underwent conventional total thyroidectomy (TT)+/- lymph node dissection (LND) without the use of NIR - parathyroid identification was done by naked eye only- by surgeon 1, from January 2015 to January 2016 (period 1)
NIR
All consecutive patients (n=63) who underwent conventional total thyroidectomy (TT)+/- lymph node dissection (LND) with intraoperative use of NIR - surgical field was examined with NIR before any thyroid dissection- by surgeon 1, from February 2016 to May 2016 (period 2)
Device: Near infrared camera (NIR)

Surgical field was examined with NIR, during a few minutes (<5') with room lights switched off, to avoid parasite lights, then conventional open thyroidectomy was resumed conventionally. Real-time images, evocative of autofluorescent parathyroids, were checked visually.

NIR consisted 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 norm IEC 60601-2-41). It was provided by the Fluobeam® camera, which was 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 1 device).

Other Names:
  • Fluobeam® system (Fluoptics®, Grenoble, France)
Control1
Patients (n=30) patients randomly selected among the patients who underwent TT+/- LND without the use of NIR, by another surgeon in the unit (surgeon 2), during period 1.
Control2
Patients (n=30) patients randomly selected among the patients who underwent TT+/- LND without the use of NIR, by surgeon 2, during period 2.

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)
immediate (intraoperative)
number of autotransplantated parathyroids
Time Frame: immediate (intraoperative)
when parathyroids are impossible to preserve in situ, they are fragmented and inserted in the sternocleidomastoid muscle
immediate (intraoperative)
number of inadvertently resected parathyroids
Time Frame: within 15 days after surgery (time to complete pathology examination)
When parathyroids are found on the thyroid specimen during pathology examination, they are called 'inadvertently resected'
within 15 days after surgery (time to complete pathology examination)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of parathyroids identified by NIR before naked eye
Time Frame: immediate (intraoperative)
in NIR group only
immediate (intraoperative)

Collaborators and Investigators

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

Sponsor

Hôpital Européen Marseille

Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Fares BENMILOUD, MD, Hôpital Européen Marseille

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

January 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ParaFluo1

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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