Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

Hypocalcemia Clinical Trial

Official title:

Parathyroid Autofluorescence Visualization During Thyroid Surgery: Impact on Postoperative Hypocalcemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889952
• Other study ID #: ParaFluo1
• Status: Completed
• Phase: N/A
• First received: August 29, 2016
• Last updated: September 6, 2016
• Start date: January 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypocalcemia

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hôpital Européen Marseille	Assistance Publique Hopitaux De Marseille

References & 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. — View Citation

McWade MA, Sanders ME, Broome JT, Solórzano 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of parathyroids identified by NIR before naked eye	in NIR group only	immediate (intraoperative)	No
Primary	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	No
Secondary	number of identified parathyroids		immediate (intraoperative)	No
Secondary	number of autotransplantated parathyroids	when parathyroids are impossible to preserve in situ, they are fragmented and inserted in the sternocleidomastoid muscle	immediate (intraoperative)	No
Secondary	number of inadvertently resected parathyroids	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)	No