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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02889952
Other study ID # ParaFluo1
Secondary ID
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


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
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