Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia

NCT ID: NCT02892253

Last Updated: 2019-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-12-20

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.

Conditions

Hypocalcemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Near Infrared Camera (NIR)

Intervention Type: DEVICE

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).

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Fluobeam® system (Fluoptics®, Grenoble, France)

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)

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

Sponsors

Hôpital Européen Marseille

OTHER

Sponsor Role: lead

Responsible Party

Fares BENMILOUD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

BENMILOUD Fares, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Europeen de Marseille

BIDAUT Wahiba, Senior CRA

Role: STUDY_CHAIR

Hopital Europeen de Marseille

REBAUDET Stanislas, MD

Role: STUDY_CHAIR

Hopital Europeen de Marseille

PENARANDA Guillaume

Role: STUDY_CHAIR

Laboratoire Alphabio

Locations

Hopital Europeen

Marseille, , France

Hôpital Saint Joseph Marseille

Marseille, , France

Hopital La Pitie Salpetriere

Paris, , France

Countries

France

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)

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.

Reference Type: DERIVED

PMID: 31693081 (View on PubMed)

Other Identifiers

2016-A-000549-42ParaFluo2

Identifier Type: -

Identifier Source: org_study_id