Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

NCT ID: NCT02889952

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 297 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-08-31

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.

Conditions

Hypocalcemia

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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)

No interventions assigned to this group

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)

Near infrared camera (NIR)

Intervention Type: DEVICE

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).

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Fluobeam® system (Fluoptics®, Grenoble, France)

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: collaborator

Hôpital Européen Marseille

OTHER

Sponsor Role: lead

Responsible Party

Fares BENMILOUD

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fares BENMILOUD, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Europeen Marseille

References

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.

Reference Type: BACKGROUND

PMID: 22236412 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26454675 (View on PubMed)

Other Identifiers

ParaFluo1

Identifier Type: -

Identifier Source: org_study_id