Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy

Phase 3

Not yet recruiting

Brief Summary: Compare the incidence of albumin-corrected hypocalcaemia (blood calcium less than 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the group using indocyanine green and the group not using indocyanine green.

Recruitment & Eligibility

Inclusion Criteria

Patients requiring total thyroidectomy

Signed consent

Patient covered by a social security scheme

Exclusion Criteria

Patients under 18 years of age

Protected adult or person incapable of giving consent to the study

Pregnant and breast-feeding women

Total thyroidectomy (removal of the remaining thyroid lobe in a patient who has already had a hemi thyroidectomy)

Previous thyroid or parathyroid surgery

Refusal to participate

Known allergic reaction to indocyanine green (ICG)

Women of childbearing age not using an adequate method of contraception

Primary Outcome Measures

Name	Time	Method
Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery		Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery

Secondary Outcome Measures

Name	Time	Method
Occurrence (yes/no) of post-operative hypocalcaemia corrected by albumin (<2mmol/L) at D8, M1 and M6		Occurrence (yes/no) of post-operative hypocalcaemia corrected by albumin (<2mmol/L) at D8, M1 and M6
Modification (yes/no) of the surgical procedure by improving detection of the parathyroids or their vascularisation during thyroidectomy with the use of indocyanine green angiography		Modification (yes/no) of the surgical procedure by improving detection of the parathyroids or their vascularisation during thyroidectomy with the use of indocyanine green angiography
Intraoperative parathyroid vitality score when using indocyanine green angiography		Intraoperative parathyroid vitality score when using indocyanine green angiography
Occurrence (yes/no) of hypoPTH on D1 and D2 post-op (<10ng/L)		Occurrence (yes/no) of hypoPTH on D1 and D2 post-op (<10ng/L)
Occurrence (yes/no) of mild (asymptomatic and >1.7mmol/l), moderate (symptomatic and >1.7mmol/l) and profound (<1.7mmol/l) hypocalcaemia in the 48 postoperative hours		Occurrence (yes/no) of mild (asymptomatic and >1.7mmol/l), moderate (symptomatic and >1.7mmol/l) and profound (<1.7mmol/l) hypocalcaemia in the 48 postoperative hours
Occurrence of an adverse reaction linked to the injection of indocyanine green		Occurrence of an adverse reaction linked to the injection of indocyanine green

Locations (1): Centre Hospitalier Regional Et Universitaire De Brest
🇫🇷
Brest, France
Centre Hospitalier Regional Et Universitaire De Brest
🇫🇷Brest, France
Jean-Christophe LECLERE
Site contact
0298223630
jean-christophe.leclere@chu-brest.fr