Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

NCT02889952 | Completed

• 1 other identifier: ParaFluo1
• Study Type: observational
• Target: 297
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypocalcemia

Keywords

postoperative hypocalcemia; near infrared imaging; parathyroid autofluorescence

Outcome Measures

Primary Outcomes (1)

• Postoperative hypocalcemia

  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 Outcomes (3)

• number of identified parathyroids

  immediate (intraoperative)

• number of autotransplantated parathyroids

  immediate (intraoperative)

• number of inadvertently resected parathyroids

  within 15 days after surgery (time to complete pathology examination)

Other Outcomes (1)

• number of parathyroids identified by NIR before naked eye

  immediate (intraoperative)

Study Arms (4)

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)

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.

Interventions

Near infrared camera (NIR) 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).

Also known as: Fluobeam® system (Fluoptics®, Grenoble, France)

NIR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients who underwent one-stage total thyroidectomy, associated or not to lymph node dissection (TT +/- LND)

You may not qualify if:

• Combined parathyroid and thyroid disease (including patients with enlarged parathyroids incidentally found during surgery and resected)

Sponsors & Collaborators

• Hôpital Européen Marseille: lead
• Assistance Publique Hopitaux De Marseille: collaborator

Related Publications (2)

• 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.

  PMID: 22236412 BACKGROUND

• 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.

  PMID: 26454675 BACKGROUND

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Study Officials

• Fares BENMILOUD, MD

  Hopital Europeen Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 7, 2016
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share