Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia

NCT02892253 | Completed DMC

• 1 other identifier: 2016-A-000549-42ParaFluo2
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 3

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.

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 autotransplanted parathyroids

  immediate (intraoperative)

• Number of inadvertently resected parathyroids

  delayed (10 days)

Study Arms (2)

NIR+ group

EXPERIMENTAL

Patients who undergo conventional total thyroidectomy (TT)+/- lymph node dissection (LND). Parathyroid identification was done with the use of NIR (intervention group, NIR+ group)

Device: Near Infrared Camera (NIR)

NIR- group

NO INTERVENTION

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)

Interventions

Near Infrared Camera (NIR) 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).

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

NIR+ group

Eligibility Criteria

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

You may qualify if:

• All patients eligible for 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

Study Sites (3)

Hopital Europeen

Marseille, 13003, France

Location

Hôpital Saint Joseph Marseille

Marseille, 13008, France

Location

Hopital La Pitie Salpetriere

Paris, 75013, France

Location

Related Publications (3)

• 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

• 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.

  PMID: 31693081 DERIVED

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

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

Study Officials

• BENMILOUD Fares, MD

  Hopital Europeen de Marseille

  PRINCIPAL INVESTIGATOR

• BIDAUT Wahiba, Senior CRA

  Hopital Europeen de Marseille

  STUDY CHAIR

• REBAUDET Stanislas, MD

  Hopital Europeen de Marseille

  STUDY CHAIR

• PENARANDA Guillaume

  Laboratoire Alphabio

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 8, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 20, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)